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Purpose: The original aim of the study was to determine, in a double-blind 3-arm crossover human trial (n = 7), the effect of supplemental levels of iron (25 mg) and zinc (30 mg) on β-carotene (synthetic) bioavailability (10 h postprandial). However, despite the high dose of supplemental β-carotene (15 mg) consumed with the high fat (18 g), dairy-based breakfast test meal, there was a negligible postprandial response in plasma and triglyceride rich fraction β-carotene concentrations. We then systematically investigated the possible reasons for this low bioavailability of β-carotene. Methods: We determined (1) if the supplemental β-carotene could be micellised and absorbed by epithelial cells, using a Caco-2 cell model, (2) if the fat from the test meal was sufficiently bioavailable to facilitate β-carotene bioavailability, (3) the extent to which the β-carotene could have been metabolised and converted to retinoic acid/retinol and (4) the effect of the test meal matrix on the β-carotene bioaccessibility (in vitro digestion) and Caco-2 cellular uptake. Results: We found that (1) The supplemental β-carotene could be micellised and absorbed by epithelial cells, (2) the postprandial plasma triacylglycerol response was substantial (approximately 75–100 mg dL−1 over 10 h), indicating sufficient lipid bioavailability to ensure β-carotene absorption, (3) the high fat content of the meal (approximately 18 g) could have resulted in increased β-carotene metabolism, (4) β-carotene bioaccessibility from the dairy-based test meal was sixfold lower (p < 0.05) than when digested with olive oil. Conclusion: The low β-carotene bioavailability is probably due to a combination of the metabolism of β-carotene to retinol by BCMO1 and interactions of β-carotene with the food matrix, decreasing the bioaccessibility. Trail registration: The human trail was retrospectively registered (ClinicalTrail.gov ID: NCT05840848). [ABSTRACT FROM AUTHOR]

Background: Previous studies have linked sports-related concussions and repeated subconcussive head impacts in contact sport athletes to elevated brain injury biomarkers. Docosahexaenoic acid (DHA), the primary omega-3 (n-3) highly unsaturated fatty acid (HUFA) in the brain, has shown neuroprotective effects in animal models after brain injury, but clinical research has shown mixed results. Methods: We conducted a randomized, double-blind, placebo-controlled study on 29 Division 1 collegiate American football players, exploring the impact of DHA (2.5 g) and eicosapentaenoic acid (EPA) (1.0 g) supplied as ethyl esters, on levels of plasma lipids shown to cross the blood-brain barrier. Dietary intake data was collected using food frequency questionnaires (FFQ). Complex lipids and unesterified fatty acids were isolated from plasma, separated via reversed-phase liquid chromatography and analyzed by targeted lipidomics analysis. Results: FFQ results indicated that participants had low dietary n-3 HUFA intake and high omega-6 (n-6):n-3 polyunsaturated fatty acids (PUFA) and HUFA ratios at baseline. After DHA + EPA supplementation, plasma lysophosphatidylcholine (LPC) containing DHA and EPA significantly increased at all timepoints (weeks 17, 21, and 26; p < 0.0001), surpassing placebo at Weeks 17 (p < 0.05) and 21 (p < 0.05). Phosphatidylcholine (PC) molecular species containing DHA or EPA, PC38:6 PC36:6, PC38:7, PC40:6, and PC40:8, increased significantly in the DHA + EPA treatment group at Weeks 17 (and 21. Plasma concentrations of non-esterified DHA and EPA rose post-supplementation in Weeks 17 and 21. Conclusions: This study demonstrates that n-3 HUFA supplementation, in the form of ethyl esters, increased the DHA and EPA containing plasma lipid pools the have the capacity to enrich brain lipids and the potential to mitigate the effects of sports-related concussions and repeated subconcussive head impacts. Trial Registration: All deidentified data are available at ClinicalTrials.gov #NCT0479207. [ABSTRACT FROM AUTHOR]

Background: Evidence suggests that statins can improve survival outcomes and ameliorate treatment-related side-effects in certain malignancies. Statins exhibit various mechanisms of action, including apoptosis induction, proliferation inhibition, tumor radiosensitization, lipid production suppression, and anti-inflammatory effects. This trial aimed to assess the impact of lovastatin on patients with locally advanced head and neck squamous cell carcinoma (HNSCC) undergoing definitive chemoradiation. Method: In this double-blinded randomized phase 2 clinical trial, 35 patients were randomly allocated to receive either 80 mg of lovastatin daily in conjunction with chemoradiotherapy (case group, n=18) or a placebo (control group, n=17). Primary outcomes included the response rate (RR) after three months, the occurrence of acute and late side-effects, median progression-free survival (PFS), and overall survival (OS). Results: The complete RR was slightly higher in the statin group (83.3% vs. 64.7%), although it did not reach statistical significance (P = 0.592). Acute adverse events did not significantly differ between the two groups. Grade 3 dermatitis occurred more frequently in the placebo group (35.3% vs. 11.1%), while grade 3 mucositis was more common in the statin group (38.9% vs. 11.8%). The median OS was 22 months (confidence interval (CI) 95% = 6.3-37.6) in the statin group and 17 months (CI 95% = 4.9-29.1) in the control group (P = 0.50). Median PFS was 20 months (CI 95% = 15.8-24.1) in the statin group and 15 months (CI 95% = 8.2-21.7) in the control group (P = 0.609). Conclusion: Combining lovastatin with chemoradiation augments the therapeutic effect in HNSCC. Larger-scale studies incorporating advanced radiotherapy techniques and baseline lipid profile assessments are necessary to investigate statins' efficacy in HNSCC further. [ABSTRACT FROM AUTHOR]

• Wheat germ improved markers of glucose homeostasis in overweight adults. • Wheat germ reduced the pro-inflammatory adipokine, resistin. • Gut microbiota and gut integrity markers were unaffected by wheat germ. Wheat germ (WG), a by-product of flour milling, is rich in bioactive substances that may help improve health complications associated with increased adiposity. This study investigated the effects of WG on gut health, metabolic, and inflammatory markers in adults classified as overweight. We hypothesized that WG, because of its many bioactive components, would improve gut health and metabolic, and inflammatory markers in overweight adults. Forty adults (18–45 years old) and with a body mass index between 25 and 30 kg/m2 participated in this single-blinded randomized controlled pilot study. Participants consumed the study supplements containing 30 g of either cornmeal (control, CL) or WG daily for 4 weeks. Primary outcome variables were gut health markers including gut microbiota, gut integrity markers, and fecal short-chain fatty acids, whereas secondary outcome variables included metabolic and inflammatory parameters assessed at baseline and at the end of supplementation. Thirty-nine participants (n = 19 and 20 for CL and WG group, respectively) completed the study. The genus Faecalibacterium was significantly higher in the WG group compared to CL post-supplementation but no significant changes in other gut health markers, short-chain fatty acids, inflammatory markers, and lipid profiles were observed. Compared with baseline, WG improved markers of glucose homeostasis including insulin (P =.02), homeostatic model assessment of insulin resistance (P =.03), glycated hemoglobin (P =.07), and the pro-inflammatory adipokine, resistin (P =.04). However, these parameters after intervention were not different with control. Our findings suggest that WG supplementation have modest effects on gut health but may provide an economical option for individuals to improve glycemic control. Daily consumption of 30 g of wheat germ supplement for 4 weeks by adults classified as overweight maintained the bacterial genus Faecalibacterium and improved several markers of glucose homeostasis including insulin, HOMA-IR, and HbA1c, and reduced the pro-inflammatory adipokine, resistin. Abbreviations: HbA1c, glycated hemoglobin; HOMA-IR, homeostatic model assessment of insulin resistance. [Display omitted] [ABSTRACT FROM AUTHOR]

Nutritional education is pivotal in the medical nutritional therapy of type 2 diabetes mellitus (T2DM). The extended parallel process model (EPPM) is a health education method for inducing desirable health behaviours. The present study aimed to investigate the effect of nutritional education based on the EPPM in T2DM patients on knowledge, attitude, practice, anthropometric indices, glycaemic factors, lipid profile and adherence to the diabetic diet. A randomised, double-blind, controlled, factorial field trial was designed for T2DM patients aged 30–59 years (n 88). Participants were randomly allocated into four groups to receive EPPM-based nutritional education through gain framed message (GFM), loss framed message (LFM), their combination (G\LFM) or usual diabetic education in the control group (CG). Participants were assessed before and after the study duration. After 3 months of intervention, eighty participants finished the study. The EPPM-based intervention increased participants' knowledge, behavioural intention, perceived sensitivity, severity, self-efficacy (P < 0·001 for all) and response efficacy (P = 0·029) in comparison with CG. GFM (P = 0·004) and G\FLM (P = 0·034) reduced carbohydrate intake and LFM (P = 0·034) and G\LFM (P = 0·047) decreased fat intake. Between-group analysis indicated interventions reduced weight (P = 0·046), BMI (P = 0·038), fasting blood sugar (P = 0·030), 2-hour postprandial blood glucose (P = 0·027) and TAG (P = 0·002) in comparison with the CG. Results were NS for protein intake, waist and hip circumference, waist:hip ratio, HbA1c, total cholesterol, LDL and HDL. Nutritional education based on EPPM could increase the knowledge and awareness of T2DM patients. Also, it could be beneficial for blood glucose amendment. Further investigations are recommended. [ABSTRACT FROM AUTHOR]

Background: This study aimed to assess the response patterns of circulating lipids to exercise and diet interventions in nonalcoholic fatty liver disease (NAFLD). Methods: The 8.6-month four-arm randomized controlled study comprised 115 NAFLD patients with prediabetes who were assigned to aerobic exercise (AEx; n = 29), low-carbohydrate diet (Diet; n = 28), AEx plus low-carbohydrate diet (AED; n = 29), and nonintervention (NI, n = 29) groups. Hepatic fat content (HFC) was quantified by proton magnetic resonance spectroscopy. Serum lipidomic analytes were measured using liquid chromatography-mass spectrometry. Results: After intervention, the total level of phosphatidylcholine (PC) increased significantly in the AEx group (P = 0.043), whereas phosphatidylethanolamine (PE) and triacylglycerol decreased significantly in the AED group (P = 0.046 and P = 0.036, respectively), and phosphatidylserine decreased in the NI group (P = 0.002). Changes of 21 lipid metabolites were significantly associated with changes of HFC, among which half belonged to PC. Most of the molecules related to insulin sensitivity belonged to sphingomyelin (40 of 79). Controlling for the change of visceral fat, the significant associations between lipid metabolites and HFC remained. In addition, baseline serum lipids could predict the response of HFC to exercise and/or diet interventions (PE15:0/18:0 for AED, area under the curve (AUC) = 0.97; PE22:6(4Z,7Z,10Z,13Z,16Z,19Z)/0:0 for AEx, AUC = 0.90; and PC14:1(9Z)/19:1(9Z) for Diet, AUC = 0.92). Conclusions: Changes of lipidome after exercise and/or diet interventions were associated with HFC reductions, which are independent of visceral fat reduction, particularly in metabolites belonging to PC. Importantly, baseline PE could predict the HFC response to exercise, and PC predicted the response to diet. These results indicate that a circulating metabolomics panel can be used to facilitate clinical implementation of lifestyle interventions for NAFLD management. [ABSTRACT FROM AUTHOR]

Background: Several studies showed the hypoglycemic and hypolipidemic effects of Satureja Khuzestanica (SK) in animal models. This study aimed to determine the effect of SK supplementation on glycemic and lipid outcomes of patients with type 2 diabetes mellitus (T2DM). Methods: The study was designed as a double-blind, placebo-controlled, randomized clinical trial using block randomization. Seventy-eight T2DM patients were randomly assigned to intervention (n = 39) or placebo (n = 39) groups. They received SK or placebo in 500 mg capsules daily for 12 weeks. Anthropometric, blood pressure, liver enzymes, glycemic, and lipid outcomes were measured before and after the intervention. Results: At baseline, there were no significant differences in age, sex, or glycated hemoglobin (HbA1c) levels between the groups. SK supplementation led to a significant decrease in FBS (-12.6 ± 20.7 mg/dl in the intervention group versus 3.5 ± 31.9 mg/dl; p = 0.007), HbA1c (-0.28 ± 0.45 in the intervention group versus 0.11 ± 0.54% in the placebo group; p = < 0.001), insulin (-1.65 ± 6.18 in the intervention group versus 2.09 ± 5.90 mIU/L in the placebo group; p = 0.03), total cholesterol (-14.6 ± 21.1 mg/dl in the intervention group versus 8.2 ± 30.9 mg/dl in the placebo group; p < 0.001), LDL-cholesterol (-4.6 ± 15.2 mg/dl in the intervention group versus 5.8 ± 14.6 mg/dl in placebo group; p < 0.001) levels, and significant increase in HDL-cholesterol (3.9 ± 4.9 mg/dl in the intervention group versus 0.9 ± 5.2 mg/dl in placebo group; p = 0.005). Conclusion: Based on the study results, SK supplementation may improve glycemic indices and lipid profile of patients with T2DM. Our findings may provide novel complementary treatments without adverse effects for diabetes complications. These results need to be further confirmed in clinical trials. Registration: : This trial has been registered in the Iranian Registry of Clinical Trials (IRCT ID: IRCT20190715044214N1, registration date: 21/02/2021). [ABSTRACT FROM AUTHOR]

Background: Rosa species are rich sources of polyphenols with physiological functions. In this study a polyphenol-rich Rosa multiflora (var. platyphylala) petal extract (RoseFit™) was investigated for weight loss in humans. Methods: In a randomized, placebo-controlled, parallel-group, double-blind clinical trial seventy overweight male and female subjects (20–50 years) with body mass index (BMI) 25–30 kg/m2 were randomly allocated to the active treatment group (RoseFit) and placebo group in a 1:1 ratio. The subjects received 300 mg capsules twice daily for 12 weeks. The primary efficacy outcome measures included body weight, BMI, and body composition, as determined using Dual-energy X-ray absorptiometry (DEXA). Secondary measures consisted of serum lipid profile and appetite marker (leptin and ghrelin) analyses. Safety analyses included biochemical and hematological assessments. Results: At the end of the study, a marked reduction in body weight (-1.20 ± 2.62 kg, p < 0.05) and BMI from baseline was observed in the RoseFit group. In addition, the body fat % (RoseFit = -1.69 ± 2.59%, placebo = 0.96 ± 3.21%; p < 0.001) and fat mass (RoseFit = -1.75 ± 1.80 kg, placebo = 1.61 ± 3.82 kg; p < 0.001) were significantly abated in RoseFit group. Importantly, the lean mass was maintained during the intervention. RoseFit ingestion significantly increased the serum leptin levels compared to the placebo (4.85%; p < 0.05). Further, RoseFit group showed reduction in the hunger hormone ghrelin level (2.27%; p < 0.001) from baseline to the end of study, compared to the placebo. The subjective evaluation of appetite using visual analog scale (VAS) questionnaires further confirmed the appetite-suppression effects of RoseFit. The lipid profile significantly improved in RoseFit-treated subjects. No serious adverse events were observed during the study, indicating the tolerability of RoseFit. Conclusions: Supplementation with RoseFit significantly impacts body weight management and can thus be a potential nutraceutical ingredient for sustainable weight loss. Trial registration: CTRI/2019/10/021584 dated 09/10/2019 [ABSTRACT FROM AUTHOR]

Anti-inflammatory activities of catechin-rich green tea extract (GTE) in obese rodents protect against metabolic endotoxemia by decreasing intestinal permeability and absorption of gut-derived endotoxin. However, translation to human health has not been established. We hypothesized that GTE would reduce endotoxemia by decreasing gut permeability and intestinal and systemic inflammation in persons with metabolic syndrome (MetS) compared with healthy persons. A randomized, double-blind, placebo-controlled, crossover trial in healthy adults (n = 19, 34 ± 2 years) and adults with MetS (n = 21, 40 ± 3 years) examined 4-week administration of a decaffeinated GTE confection (890 mg/d total catechins) on serum endotoxin, intestinal permeability, gut and systemic inflammation, and cardiometabolic parameters. Compared with the placebo, the GTE confection decreased serum endotoxin (P =.023) in both healthy persons and those with MetS, while increasing concentrations of circulating catechins (P <.0001) and γ-valerolactones (P =.0001). Fecal calprotectin (P =.029) and myeloperoxidase (P =.048) concentrations were decreased by GTE regardless of health status. Following the ingestion of gut permeability probes, urinary lactose/mannitol (P =.043) but not sucralose/erythritol (P >.05) was decreased by GTE regardless of health status. No between-treatment differences (P >.05) were observed for plasma aminotransferases, blood pressure, plasma lipids, or body mass nor were plasma tumor necrosis factor-α, interleukin-6, or the ratio of lipopolysaccharide-binding protein/soluble cluster of differentiation-14 affected. However, fasting glucose in both study groups was decreased (P =.029) by the GTE confection compared with within-treatment arm baseline concentrations. These findings demonstrate that catechin-rich GTE is effective to decrease circulating endotoxin and improve glycemic control in healthy adults and those with MetS, likely by reducing gut inflammation and small intestinal permeability but without affecting systemic inflammation. • A novel green tea extract (GTE) confection was provided to healthy adults and adults with metabolic syndrome. • GTE increased circulating catechins and valerolactones regardless of health status. • GTE decreased intestinal inflammation and small intestinal permeability. • GTE decreased circulating endotoxin. • GTE decreased fasting glucose without affecting systemic inflammation. • Gut-level benefits by GTE support research translation for cardioprotection by green tea. Healthy adults and adults with metabolic syndrome were randomized to a placebo or GTE (1 g; 890 mg catechins) confection for 1 month and then crossed-over to the alternative treatment following a 1-month washout. Regardless of health status, the GTE confection decreased fecal biomarkers of intestinal inflammation (calprotectin and myeloperoxidase) and small intestinal permeability based on a differential sugar absorption test while decreasing serum endotoxin. Abbreviations: GTE, green tea extract; MetS, metabolic syndrome [Display omitted] [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to assess the possible clinical effects of vitamin K4 supplementation in individuals with type 2 diabetes namely insulin resistance, glycaemic control, and lipid profile. Methods: This was a prospective randomised double-blind placebo-controlled clinical trial. A total of 106 patients were randomised to receive either 1 mg of vitamin K4 (menadiol diacetate) or placebo for 24 weeks. Results: Ninety patients (n = 45 in each study group) were included in the final analysis. After 24 weeks, homeostatic model assessment of insulin resistance (HOMA-IR) (16.54 ± 7.81 vs. 29.09 ± 36.56, P = 0.027) and fasting serum insulin (FSI) (6.86 ± 3.45 vs. 11.13 ± 12.66 µU/ml, P = 0.032) were significantly lower in the vitamin K group compared to placebo. Additionally, triglycerides (TG) (144.94 ± 50.7 vs. 172.8 ± 101.5 mg/dl, P = 0.031) and very low-density lipoproteins (VLDL) levels (28.9 ± 9.88 vs. 34.6 ± 20.30 mg/dl, P = 0.027) decreased significantly in the vitamin K group after 24 weeks compared to baseline. Moreover, more patients in the vitamin K group (35.6%) had their antidiabetic medication doses reduced after 24 weeks compared to placebo (13.3%, P = 0.029). Conclusion: Vitamin K4 supplementation for 24 weeks is capable of improving insulin resistance and TG levels in individuals with type 2 diabetes. In addition, the improvement in insulin resistance was reflected in the decrease in antidiabetic medication doses. However, it did not affect fasting plasma glucose (FPG) or glycated haemoglobin (HbA1c). Trial registration: The study was registered on clinicaltrials.gov with ID: NCT04285450. [ABSTRACT FROM AUTHOR]

Euglena gracilis (Euglena) is a microalgae found in most freshwater environments that produces paramylon, an insoluble β-1,3-glucan linked to human immunity. We hypothesized that Euglena powder has effects on immune function in apparently healthy adults. The study included male or female volunteers between the ages of 20 and 70 years who had white blood cell counts ranging from 4 × 103/µL to 10 × 103/µL, a "severe" rating on the stress questionnaire from the Korea National Health and Nutrition Examination Survey, and at least 2 upper respiratory infections with cold-like symptoms in the previous year. Participants received either a placebo or 700 mg of Euglena powder daily for 8 weeks. The study measured natural killer cell activity, cytokine concentrations, and blood lipid profiles to confirm the immune effect of Euglena consumption. In conclusion, Euglena improved immunological function through natural killer cell activity. Safety assessment showed no significant changes in vital signs or clinical chemistry indicators, and there were no adverse events associated with Euglena consumption. Euglena supplementation may help boost the immune systems of healthy individuals. Euglena gracilis is a freshwater microalgae that produces paramylon, which benefits human immunity. This study examined the effects of Euglena on immune function in apparently healthy subjects. Participants received either a placebo or 700 mg of Euglena powder daily for 8 weeks. Results showed improved immune function through natural killer (NK) cell activity, with no adverse events or safety concerns. Euglena supplementation may enhance the immune systems of apparently healthy individuals. [Display omitted] [ABSTRACT FROM AUTHOR]

Global rates of adolescent obesity have led the World Health Organization to consider the disease a pandemic that needs focus. In search of new anti-obesity agents, Crocus sativus, popularly known as saffron, is a nutraceutical agent, praised for its beneficial effects. The study aimed to investigate the possible effect of Kozanis saffron administration on weight management of obese prediabetic adolescents. Seventy-four obese prediabetic adolescents participated in a double-blind placebo-controlled trial of three arms, randomly assigned to receive either Kozanis saffron (n = 25, 60 mg/day), metformin (n = 25, 1000 mg/day) or a placebo (n = 24), for twelve weeks. Anthropometry, glycemic markers and lipid profiles were investigated at baseline and post-intervention. Saffron supplementation significantly reduced the weight z-score, BMI, BMI z-score and waist circumference (WC) of obese adolescents; however, this reduction was less significant compared to the effect of metformin. Metformin administration offered a significantly more profound improvement in anthropometry compared to saffron administration. Saffron administration also provided significant improvements in weight, weight z-scores, BMI values, BMI z-scores and WCs compared to the placebo. Saffron supplementation failed to change any glycemic marker, but provided a significant reduction in fasting triglyceride levels and also a significant increase in fasting HDL levels. Saffron Kozanis constitutes a promising nutraceutical option for adolescents and children with obesity and prediabetes in need of weight management. [ABSTRACT FROM AUTHOR]

Introduction: Menopause is a condition for metabolic disorders. This study aimed to evaluate the effect of Nigella sativa (NS), curcumin nanomicelle (CN), lipid profile, glycemic status and 17-β estradiol (ES) levels in postmenopausal women. Methods: Triple-blind randomized clinical trial was conducted on 120 postmenopausal women. Participants were randomly assigned to four groups: 1) NS capsule 1000 mg and CN placebo, 2) 80 mg CN capsule and NS placebo, 3) both NS and CN capsules and 4) NS and CN placebo. Participants received a single dose daily for 6 months. The serum lipid profile, glycemic control biomarkers, and ES were measured pre-and post-intervention using biochemical methods. Results: Total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, fasting blood sugar (FBS), fasting insulin (FI), insulin resistance (IR), and ES showed significant improvement in NS group. CN significantly reduced TC, FI, and IR, and significantly increased ES. The combination of NS-CN significantly decreased TC, LDL, FI, and IR, and increased HDL and ES. The comparison of the studied with the placebo groups showed that these changes were significant in glycemic indices and NS significantly increased estrogen. Conclusion: NS, CN and NS-CN improved lipid profiles, blood sugar, and hormone levels. However, this improvement was significant in glycemic indices and estrogen levels compared to the placebo group. No superiority of combined NS-CN over NS or CN was found in this trial. [ABSTRACT FROM AUTHOR]

Olive oil (OO) polyphenols have been shown to improve HDL anti-atherogenic function, thus demonstrating beneficial effects against cardiovascular risk factors. The aim of the present study was to investigate the effect of extra virgin high polyphenol olive oil (HPOO) v. low polyphenol olive oil (LPOO) on the capacity of HDL to promote cholesterol efflux in healthy adults. In a double-blind, randomised cross-over trial, fifty participants (aged 38·5 (sd 13·9) years, 66 % females) were supplemented with a daily dose (60 ml) of HPOO (320 mg/kg polyphenols) or LPOO (86 mg/kg polyphenols) for 3 weeks. Following a 2-week washout period, participants crossed over to the alternate treatment. Serum HDL-cholesterol efflux capacity, circulating lipids (i.e. total cholesterol, TAG, HDL, LDL) and anthropometrics were measured at baseline and follow-up. No significant between-group differences were observed. Furthermore, no significant changes in HDL-cholesterol efflux were found within either the LPOO and HPOO treatment arms; mean changes were 0·54 % (95 % CI (0·29, 1·37)) and 0·10 % (95 % CI (0·74, 0·94)), respectively. Serum HDL increased significantly after LPOO and HPOO intake by 0·13 mmol/l (95 % CI (0·04, 0·22)) and 0·10 mmol/l (95 % CI (0·02, 0·19)), respectively. A small but significant increase in LDL of 0·14 mmol/l (95 % CI (0·001, 0·28)) was observed following the HPOO intervention. Our results suggest that additional research is warranted to further understand the effect of OO with different phenolic content on mechanisms of cholesterol efflux via different pathways in multi-ethnic populations with diverse diets. [ABSTRACT FROM AUTHOR]

Objective: Metabolic syndrome is a potential side effect of atypical antipsychotics which are the current standard treatment for schizophrenia. Therefore, we aimed to examine the effect of barberry root (Berberis vulgaris) on the prevention of metabolic syndrome caused by atypical antipsychotic drugs in patients with schizophrenia. Method: Our research was a three-blind randomized clinical trial. The participants included all patients who were diagnosed with schizophrenia through the SCID-5 questionnaire and based on the DSM-5-TR criteria by two psychiatric experts. These patients were randomly divided into intervention and placebo groups. During a three-month treatment period, the intervention group received three 500 mg capsules of barberry root extract daily, whereas the placebo group received the same capsules containing 500 mg of starch powder. Metabolic syndrome variables including fasting blood glucose, serum lipids (triglyceride and cholesterol), blood pressure, weight and waist circumference were measured before and after the treatment as outcome measure. Chi-square and t-tests were used for data analysis using SPSS-22 software. Results: At the beginning of the study, there was no significant difference between the intervention group (n = 41) and the placebo group (n = 47) in terms of demographic factors, and pre-treatment assessments including weight, waist size, fasting blood HDL, fasting blood triglycerides and systolic and diastolic blood pressure and fasting blood glucose (P > 0.05). Within group analysis showed that some metabolic factors significantly increased in both groups after the treatment (P < 0.05). Indeed, in both groups, metabolic syndrome measures worsened after the three-month treatment period. The parameters of weight and waist size were significantly higher in the intervention group than the placebo group after treatment (P < 0.05). Conclusion: Barberry root extract was not able to control the Effects of antipsychotic drugs on metabolic syndrome in schizophrenia. [ABSTRACT FROM AUTHOR]

Introduction: Cardiovascular disease (CVD) has become a leading cause of morbidity and mortality among people with HIV. Atorvastatin is known to reduce cardiovascular risk. We (1) compared atorvastatin concentrations between different boosted protease inhibitors (PIs) and with lipid outcomes and (2) compared pre‐atorvastatin 25‐OH vitamin D levels with atorvastatin concentrations and with lipid outcomes, in people with HIV with suppressed HIV‐1 RNA and low‐density lipoprotein cholesterol (LDL‐C) <130 mg/dL. Methods: A5275 was a randomized, double‐blind, placebo‐controlled crossover study of atorvastatin in virally suppressed people with HIV with fasting LDL‐C <130 mg/dL. We analyzed results over the 20 weeks of active atorvastatin treatment. Atorvastatin was initiated at 10 mg daily and increased to 20 mg daily after 4 weeks if there were no findings of toxicity. Atorvastatin trough concentrations were measured at week 20. Participants took combination antiretroviral therapy (ART) that included a boosted PI throughout. Results: Overall (n = 67), 70% of participants were male, and the median age was 51 years. There was no apparent association between atorvastatin trough concentrations and pre‐atorvastatin vitamin D levels (r = 0.01, p = 0.9) or by boosted PI (p = 0.20). Median pre‐ to post‐atorvastatin change was −39.0 mg/dL in fasting total cholesterol, −40.4 ng/mL in lipoprotein‐associated phospholipase A2 (LP‐PLA2), and −13.8 U/L in oxidized LDL, with all changes negatively correlated with atorvastatin trough concentrations (r = −0.19, −0.09, −0.21; p ≥ 0.096). Conclusions: No apparent associations between pre‐atorvastatin vitamin D levels and outcomes were observed (all p > 0.70). In virologically suppressed people with HIV, higher atorvastatin concentrations were marginally associated with greater decreases in lipid outcomes. [ABSTRACT FROM AUTHOR]

Middle-aged women have an increased risk of chronic degenerative diseases and reduced physical strength, which can lead to decreased vascular function and an increased risk of cardiovascular disease. However, these problems can be treated or prevented with healthy nutrition and regular exercise. We focused on these benefits as recent studies have reported the potential synergistic effects of suspension training and nutrition. Therefore, in this study, we investigated the effects of 12 weeks of adlay intake and suspension training on improvements in body composition, physical fitness, blood lipids, and arterial stiffness in middle-aged women. Neither the adlay + suspension exercise (ASEG) nor suspension exercise groups (SEG) showed significant changes in body composition. Nonetheless, with respect to physical fitness, there was a difference in time among all variables except flexibility, though the ASEG showed a more significant effect than the SEG. Regarding blood lipids, significant interaction effects were found for triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol, while only the ASEG significantly improved these parameters. Furthermore, pulse wave velocity was only significantly decreased in the ASEG. In summary, performing suspension exercises for 12 weeks improved physical strength in middle-aged women. Additionally, when adlay was consumed simultaneously, blood lipids and arterial stiffness were improved. [ABSTRACT FROM AUTHOR]

Background and Hypotheses Weight gain and adverse cardiometabolic effects often limit the clinical utility of olanzapine. In ENLIGHTEN-2, combining olanzapine with the opioid receptor antagonist samidorphan (OLZ/SAM) mitigated olanzapine-associated weight gain. These analyses tested the hypothesis that OLZ/SAM would be associated with reduced adverse cardiometabolic effects compared with olanzapine. Study Design This phase 3 double-blind study randomized adults with schizophrenia to OLZ/SAM or olanzapine for 24 weeks. Post hoc analyses assessed changes from baseline to week 24 in cardiometabolic risk parameters, including body mass index (BMI), risk of developing obesity (BMI ≥30 kg/m2) or metabolic syndrome, waist circumference, along with mean and potentially clinically significant changes in blood pressure, glucose, and lipids. Results After 24 weeks' treatment, compared with olanzapine, OLZ/SAM was associated with smaller least-squares mean (LSM) changes from baseline in systolic blood pressure (LSM difference, −2.63 mm Hg; 95% CI: −4.78, −0.47), diastolic blood pressure (LSM difference, −0.75 mm Hg; 95% CI: −2.31, 0.80), and BMI (LSM difference, −0.65 kg/m2; 95% CI: −1.01, −0.28). OLZ/SAM treatment was also associated with reduced risk of shifting from normal blood pressure to stage 1/2 hypertension (odds ratio [OR], 0.48; 95% CI: 0.24, 0.96), becoming obese (OR, 0.52; 95% CI: 0.32, 0.82), and developing metabolic syndrome (OR, 0.55; 95% CI: 0.31, 0.99) compared with olanzapine. No treatment group differences were noted for risk of hyperglycemia or hyperlipidemia. Conclusions OLZ/SAM treatment was associated with lower risk of worsening cardiometabolic risk factors related to obesity, hypertension, and metabolic syndrome relative to olanzapine. NCT02694328, https://clinicaltrials.gov/ct2/show/NCT02694328. [ABSTRACT FROM AUTHOR]

• In familial dysbetalipoproteinemia (FD), evolocumab reduced non-HDL-C by 49%. • Non-HDL-C treatment goals were achieved by 89% of patients using evolocumab. • Evolocumab likely results in CVD reduction in FD. Familial dysbetalipoproteinemia (FD) is the second most common monogenic lipid disorder (prevalence 1 in 850-3500), characterized by postprandial remnant accumulation and associated with increased cardiovascular disease (CVD) risk. Many FD patients do not achieve non-HDL-C treatment goals, indicating the need for additional lipid-lowering treatment options. To evaluate the effect of the PCSK9 monoclonal antibody evolocumab added to standard lipid-lowering therapy on fasting and post fat load lipids and lipoproteins in patients with FD. A randomized placebo-controlled double-blind crossover trial comparing evolocumab (140 mg subcutaneous every 2 weeks) with placebo during two 12-week treatment periods. At the start and end of each treatment period patients received an oral fat load. The primary endpoint was the 8-hour post fat load non-HDL-C area under the curve (AUC). Secondary endpoints included fasting and post fat load lipids and lipoproteins. In total, 28 patients completed the study. Mean age was 62±9 years and 93% had an Ɛ2Ɛ2 genotype. Evolocumab reduced the 8-hour post fat load non-HDL-C AUC with 49% (95%CI 42-55) and apolipoprotein B (apoB) AUC with 47% (95%CI 41-53). Other fasting and absolute post fat load lipids and lipoproteins including triglycerides and remnant-cholesterol were also significantly reduced by evolocumab. However, evolocumab did not have significant effects on the rise above fasting levels that occurred after consumption of the oral fat load. Evolocumab added to standard lipid-lowering therapy significantly reduced fasting and absolute post fat load concentrations of non-HDL-C, apoB and other atherogenic lipids and lipoproteins in FD patients. The clinically significant decrease in lipids and lipoproteins can be expected to translate into a reduction in CVD risk in these high-risk patients. [Display omitted] [ABSTRACT FROM AUTHOR]

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Introduction: Oligonol, an oligomerized-polyphenol from Litchi chinensis extract, has been shown to alleviate metabolic syndrome. The aim of this study was to evaluate the effects of oligonol in patients with nonalcoholic fatty liver disease (NAFLD). Methods: Adult patients with NAFLD defined by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) ≥11% were enrolled and then randomly assigned to receive either oligonol or placebo capsules. Primary endpoint was ≥30% reduction in MRI-PDFF at 24 weeks. Secondary outcomes were reductions in bodyweight, waist circumference, alanine transaminase, fasting blood sugar, and lipid profiles at week 24. Results: Forty patients were enrolled (n = 20/group). Primary endpoint was achieved in 20% in the oligonol group and 15% in the placebo group (p = 0.50). The authors found a reduction in MRI-PDFF between weeks 0 and 24 in the oligonol group; however, the change was not different from the placebo group. Secondary outcomes were similar between two groups. Discussion: Oligonol has not shown a significant therapeutic effect in NAFLD. Future studies with a longer duration of therapy might be needed to achieve the primary endpoint. Clinical Trial Registration Number: Thai Clinical Trial Registry identification number: TCTR20200814001. [ABSTRACT FROM AUTHOR]

Daily pecan consumption improves fasting and postprandial triglycerides, but its effect on angiopoietin-like proteins (ANGPTLs) is unknown. The objective of this study was to investigate the impact of daily pecan consumption for 8 weeks on fasting and postprandial ANGPTL3, −8, and −4. This was an 8-week, randomized, controlled trial with three treatments: two pecan groups and a nut-free control group (n = 16). The ADD group (n = 15) consumed pecans (68 g) as part of a free-living diet, and the SUB group (n = 16) substituted the pecans (68 g) for isocaloric foods from their habitual diet. Fifty-six participants were randomized but nine subjects did not begin or finish the 8-week intervention and/or testing visits. At pre- and post-intervention, a high saturated fat meal was consumed with 3.5 h postprandial blood draws to determine changes in ANGPTL3, −8, and −4. There was a significant suppression in postprandial ANGPTL3 from pre- to post-intervention within ADD and SUB (P = .004 and P = .002, respectively) but not control (ns). There were no other changes within or between groups for fasting and postprandial outcomes. Daily pecan consumption improved postprandial ANGPTL3, which may mediate improvements in lipid metabolism. [ABSTRACT FROM AUTHOR]

• EPA and DHA lowered plasma TG concentrations. • Changes in TG concentrations were inversely associated with changes in LPL activity. • DHA increased LDL-C concentrations. • EPA and DHA plasma lipid changes varied by sex. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been shown to similarly lower plasma TG concentrations but differentially regulate plasma LDL-C and HDL-C concentrations. The aim of this study was to evaluate the common and differential effects of these ω-3 fatty acids on plasma lipids and lipoproteins and to assess the metabolic mechanisms of the effects. In a randomized, double-blind, crossover study, we assessed the effect of 10-week supplementation with 3 g/d pure EPA and pure DHA (both as ethyl ester, ≥97% purity) on plasma lipid and lipoprotein concentrations and activities of lipoprotein lipase (LPL), cholesteryl ester transfer protein (CETP) and lecithin:cholesterol acyl transferase (LCAT) in 21 older (>50 y) men and postmenopausal women with some characteristics of metabolic syndrome and low-grade chronic inflammation. Both EPA and DHA lowered plasma TG concentrations and increased LDL-C/apoB and HDL-C/apoA-I ratios, but only DHA increased LDL-C concentrations. The reductions in plasma TG were inversely associated with the changes in LPL activity after both EPA and DHA supplementation. EPA lowered CETP, while DHA lowered LCAT activity. EPA and DHA worked differently in men and women, with DHA increasing LPL activity and LDL-C concentrations in women, but not in men. EPA and DHA exerted similar effects on plasma TG, but differences were observed in LDL-C concentrations and activities of some enzymes involved in lipoprotein metabolism. It was also noted that EPA and DHA worked differently in men and women, supporting sex-specific variations in lipoprotein metabolism. [ABSTRACT FROM AUTHOR]

Background. Sumac fruit is an antioxidant and reduces serum triglyceride (TG) and cholesterol (CHOL) levels. Therefore, this study aimed to investigate the effect of sumac fruit on serum lipids and body mass index (BMI) of hemodialysis (HD) patients. Materials and Methods. This triple-blind randomized clinical trial study was conducted for 12 weeks on HD patients. Participants were randomly divided into three groups of 2-gram sumac (N = 40), 3-gram sumac (N = 40), and placebo (N = 40) by nonprobability consecutive sampling and stratified block randomization method based on inclusion criteria. Serum lipids and BMI were measured at the beginning of the study and also at the end of the sixth and the twelfth weeks. The physical activity and 24-hour dietary recall questionnaires were used to collect data. Results. No significant difference was found between the level of nutrient and micronutrient intake (P > 0.05), physical activity (P = 0.159), and BMI (P = 0.718) of patients in the three groups before and after the intervention. However, the difference in serum low-density lipoprotein (LDL) levels in each studied group was significant over time (P < 0.001). The difference was not statistically significant between the groups before the intervention, 6 and 12 weeks after the intervention (group effect), and between the study groups over time (time-group interaction). No statistically significant difference was observed between the mean levels of TG (P = 0.875), CHOL level (P = 0.969), LDL level (P = 0.998), high-density lipoprotein (HDL) level (P = 0.136), and BMI (P = 0.608) in the groups over time. Conclusion. Consumption of sumac fruit significantly changed the LDL level over time. Although BMI and serum lipids changed in HD patients, these changes were not significant. Future studies are needed to determine the effective dose of sumac and any dose increase should take toxicity into account and consider a larger sample size and longer intervention and follow-up times. [ABSTRACT FROM AUTHOR]

Aims: To compare the effects of replacing regular dietary oils intake with sesame (SO), canola (CO), and sesame–canola (SCO) oils (a novel blend), on cardiometabolic markers in adults with type 2 diabetes mellitus (T2DM), in a triple-blind, three-way, randomized, crossover clinical trial. Methods: Participants were assigned to receive SO, CO, and SCO in three 9-week phases (4 weeks apart). Cardiometabolic makers (serum lipids, Apolipoprotein, cardiovascular risk scores, kidney markers, and blood pressure) were considered at the beginning and the end of intervention phases. Results: Ninety-two, ninety-five, and ninety-five participants completed the SO, SCO, and CO periods, respectively. After CO consumption, serum Apo A-1 concentrations were significantly higher compared with the SCO period in the whole population (p < 0.05). A considerable reduction in visceral adiposity index values was seen in the CO compared with the SO period in males (p < 0.05). Serum high-density lipoprotein concentration was also significantly higher after the SO intake compared with SCO in females (p < 0.05). The between-period analysis showed a substantial reduction in diastolic blood pressure in the SCO period compared with the CO and SO periods and lower systolic blood pressure after SCO versus CO intake in males (p < 0.05). Conclusions: Canola oil might protect CVD through improving Apo A-1 levels in patients with T2DM (particularly in females) and visceral adiposity index in male patients. However, the blend oil might beneficially affect blood pressure in men. Future sex-specific studies might warrant the current findings. Registry of clinical trials: This trial was registered in the Iranian Registry of Clinical Trials (IRCT, registration ID: IRCT2016091312571N6). [ABSTRACT FROM AUTHOR]

Background: Chitosan is one of dietary fiber that has received great attention in improving obesity-related markers, but little is known on its effects on adolescents.Objectives: To analyze the effects of chitosan supplementation on obesity-related cardiometabolic markers and appetite-related hormones in adolescents with overweight or obesity.Methods and Analysis: A randomized clinical trial was performed on 64 adolescents with overweight and obesity, who were randomly allocated to receive chitosan supplementation (n = 32) or placebo as control (n = 32) for 12 weeks. Anthropometric measures, lipid and glycemic profiles, and appetite-related hormones were examined.Results: Sixty-one participants completed study (chitosan = 31, placebo = 30). Chitosan supplementation significantly improved anthropometric indicators of obesity (body weight: - 3.58 ± 2.17 kg, waist circumference: - 5.00 ± 3.11 cm, and body mass index: - 1.61 ± 0.99 kg/m2 and - 0.28 ± 0.19 Z-score), lipid (triglycerides: - 5.67 ± 9.24, total cholesterol: - 14.12 ± 13.34, LDL-C: - 7.18 ± 10.16, and HDL-C: 1.83 ± 4.64 mg/dL) and glycemic markers (insulin: - 5.51 ± 7.52 μIU/mL, fasting blood glucose: - 5.77 ± 6.93 mg/dL, and homeostasis model assessment of insulin resistance: - 0.24 ± 0.44), and appetite-related hormones (adiponectin: 1.69 ± 2.13 ng/dL, leptin - 19.40 ± 16.89, and neuropeptide Y: - 41.96 ± 79.34 ng/dL). When compared with the placebo group, chitosan supplementation had greater improvement in body weight, body mass index (kg/m2 and Z-score), waist circumference, as well as insulin, adiponectin, and leptin levels. Differences were significant according to P-value < 0.05.Conclusion: Chitosan supplementation can improve cardiometabolic parameters (anthropometric indicators of obesity and lipid and glycemic markers) and appetite-related hormones (adiponectin, leptin, and NPY) in adolescents with overweight or obesity. [ABSTRACT FROM AUTHOR]

Vegetable oils having unsaturated fatty acids in the sn-2 position of triglyceride (TG) backbone might not raise serum cholesterol levels. We investigated the chronic effects of diets enriched with palm olein (IV64) (PO), cocoa butter (CB), or extra virgin olive oil (EVOO) with oleic acid primarily at the sn-2 position (66%, 75%, 87% sn-2 oleic acid, respectively) of the TG molecule in 40 healthy volunteers participated in this randomized, controlled, single-blinded, crossover trial. Following a 2-week run-in period, the subjects were given standardization meals (breakfast, lunch, and dinner) cooked with palm olein (IV72). Subjects were randomized to 1 of the 3 intervention groups; receiving baked products (brownies for breakfast and cookies for teatime) prepared with respective test fats accompanied with standardized low-fat meals for breakfast, lunch, and dinner prepared with palm olein (IV72) for all groups for 4 weeks in a crossover manner with 2-week washout period (given standardization meals). Anthropometric measurements, blood samples, and dietary intakes were measured before run-in and pre- and post-intervention. No significant difference was observed on the primary outcome of the study total: high-density lipoprotein cholesterol. All 3 test fats were found to exhibit similar lipid responses (total cholesterol, TG, lipoprotein (a), apolipoprotein-A1, apolipoprotein-B/A-1). Statistical difference was found on low-density lipoprotein cholesterol (CB>EVOO by 0.3 mmol/L, P =.003), high-density lipoprotein cholesterol (PO>CB by 0.04 mmol/L, P =.02) and apolipoprotein-B (EVOO

Objective: Due to insufficient data on the metabolic consequences of long-term whey protein consumption, in this trial, we aimed to examine the effects of whey protein, as fortified bread, on glycemic status, lipid profile, and blood pressure in overweight/obese women with type 2 diabetes mellitus. Methods: In a 12-week double-blind placebo-controlled randomized clinical trial, 48 overweight/obese women with type 2 diabetes mellitus were randomly allocated into either whey protein (bread fortified by 20 g whey protein concentrate) or placebo (unfortified bread) group. At pre- and postintervention phase, physical activity, blood pressure, serum levels of glucose, insulin, glycosylated hemoglobin A1C, lipid profile, and dietary intakes were assessed. The homeostatic model assessment for insulin resistance was used for the estimation of insulin resistance. Results: Totally 35 patients completed the trial. At the endpoint, there were no significant between-group differences for the assessed glycemic parameters (P > .05), except glycosylated hemoglobin A1C, which was higher in the whey protein group after adjusting for the confounders and baseline values (P < .05). Fasting blood glucose was significantly increased in whey protein group (P < .05). There was a significant increase in HOMA-IR and serum level of insulin in both whey protein and placebo groups (P < .05). There were no significant within- or between-group changes in the lipid profile and blood pressure of the patients (P > .05). Conclusion: Three-month consumption of the whey protein concentrate fortified bread has no effects on lipid profile and blood pressure. It may cause some undesirable changes in some glycemic indices among overweight/obese women with type 2 diabetes mellitus. [ABSTRACT FROM AUTHOR]

Background Osteoarthritis (OA) is a major cause of chronic pain and disability worldwide. Treatment generally focuses on symptom relief through nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics, which may incur side effects. Krill oil, rich in anti-inflammatory long-chain (LC) omega-3 (ω–3) PUFAs and astaxanthin, may be a safe and effective alternative treatment. Objectives This study sought to investigate the effects of a commercially available krill oil supplement on knee pain in adults with mild to moderate knee OA. Secondary outcomes were knee stiffness; physical function; NSAID use; Omega-3 Index; and lipid, inflammatory, and safety markers. Methods Healthy adults (n  = 235, 40–65 y old, BMI >18.5 to <35 kg/m2), clinically diagnosed with mild to moderate knee OA, regular knee pain, and consuming <0.5 g/d LC ω-3 PUFAs, participated in a 6-mo double-blind, randomized, placebo-controlled, multicenter trial. Participants consumed either 4 g krill oil/d (0.60 g EPA/d, 0.28 g DHA/d, 0.45 g astaxanthin/d) or placebo (mixed vegetable oil). Knee outcomes were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) numeric scale (normalized to scores of 0–100). Outcomes were assessed at baseline, 3 mo, and 6 mo. Results Omega-3 Index increased with the krill oil supplement compared with placebo (from 6.0% to 8.9% compared with from 5.5% to 5.4%, P  < 0.001). Knee pain score improved in both groups with greater improvements for krill oil than for placebo (difference in adjusted mean change between groups at 6 mo: −5.18; 95% CI: −10.0, −0.32; P  = 0.04). Knee stiffness and physical function also had greater improvements with krill oil than with placebo (difference in adjusted mean change between groups at 6 mo: −6.45; 95% CI: −12.1, −0.9 and −4.67; 95% CI: −9.26, −0.05, respectively; P  < 0.05). NSAID use, serum lipids, and inflammatory and safety markers did not differ between groups. Conclusions Krill oil was safe to consume and resulted in modest improvements in knee pain, stiffness, and physical function in adults with mild to moderate knee OA. This trial was registered at clinicaltrials.gov as NCT03483090. [ABSTRACT FROM AUTHOR]

Background: The aim of the present study was to investigate the effects of melatonin supplementation along with nonsurgical periodontal therapy (NSPT) in patients with type 2 diabetes mellitus (T2DM) and chronic periodontitis (CP). Materials and Methods: The present study was a double-blind clinical trial. Fifty diabetic patients with periodontitis were randomly allocated to control (n = 25) and intervention groups (n = 25). Two tablets of 250 mg melatonin (6 mg net melatonin) or placebo were received by the intervention or control groups once a day for 8 weeks. Fasting blood glucose (FBG), glycosylated hemoglobin levels (HbA1c), lipid profile, systolic and diastolic blood pressure (SBP and DBP), anthropometric indices including weight, waist and hip circumference (WC and HC), and body mass index (BMI) were measured in patients at the beginning and end of the intervention. Results: Forty-four patients (22 patients in each group) completed the study. In the intervention group, a significant reduction was observed in HbA1c (P = 0.004), weight, BMI, WC, HC (all P < 0.001), DBP (P = 0.017), and SBP (P = 0.006). The high-density lipoprotein-cholesterol was significantly increased in the intervention group after the intervention (P = 0.007). Moreover, after the adjustment of confounding factors, the mean changes of HbA1c (mean difference: -1.30, confidence interval [CI]: -2.41-0.19, P = 0.02), weight (mean difference: -3.90, CI: -5.30-2.50, P < 0.001), WC (mean difference: -1.37, CI: -2.19-0.55, P = 0.002), BMI (mean difference: -1.41, CI: -1.92-0.89, P < 0.001), HC (mean difference: -3.55, CI: -4.74-2.35, P < 0.001), and SBP (mean difference: -1.24, CI: -2.41-0.06, P = 0.03) improved significantly in the intervention group by comparison with the control group. No side effects were reported during the study. Conclusion: The adjunct therapy of NSPT and melatonin may be useful in controlling the glycemic index, lipid profile, BP, and weight in T2DM with CP. [ABSTRACT FROM AUTHOR]

Purpose: Heart rate reduction (HR) is a cornerstone in heart failure therapy as it improves patient outcomes. The aim of this study is to evaluate short-term effect of ivabradine on NT-Pro BNP and neopterin in heart failure patients and assess the association between HR and these biomarkers. Methods: Sixty patients on standard heart failure therapy were randomly allocated into ivabradine group (n = 30) and non-ivabradine group (n = 30). Ivabradine 5 mg twice daily was given for 3 months. Lipid profile and kidney functions were performed and blood samples for NT-Pro BNP and neopterin were analysed at baseline and after 3 months of intervention in both groups. Results: There was a significant improvement in NYHA class in ivabradine group (p < 0.001). Ejection fraction was improved in ivabradine and non-ivabradine groups after intervention (p < 0.001), with a greater improvement in ivabradine group (p = 0.026). Heart rate was reduced in ivabradine group (p < 0.001) and non-ivabradine group (p < 0.001) yet greater reduction was seen in ivabradine group (p < 0.001). Serum creatinine and blood urea nitrogen were reduced in ivabradine group (Scr: p = 0.001, BUN: p = 0.001). NT-Pro BNP and neopterin levels significantly decreased in ivabradine group (NT-Pro BNP: p < 0.001, neopterin p < 0.001). Significant positive correlation was found between HR and biomarker levels after intervention (NT-Pro BNP: r = 0.475, p < 0.001, neopterin: r = 0.384, p = 0.002). Conclusion: Ivabradine therapy reduced levels of both biomarkers which correlated well with HR. Biomarker levels might provide a tool for assessing ivabradine effectiveness in HF. Trial registration Date: June 26, 2020. Identifier: NCT04448899. Link: Ivabradine in Patients with Congestive Heart Failure—Full Text View—ClinicalTrials.gov. [ABSTRACT FROM AUTHOR]

Purpose: Polycystic ovary syndrome (PCOS) is a common endocrine disorder among reproductive-age women. Insulin resistance and dyslipidemia are linked to PCOS. l-Carnitine supplementation as a management strategy for women with PCOS has been proposed. The effect of l-carnitine supplementation on insulin resistance, sex hormone-binding globulin (SHBG) and lipid profile in overweight/obese women with PCOS was investigated. Methods: This randomized, double-blind, controlled clinical trial, was conducted on 62overweight/obese women with PCOS. Participants were randomly assigned into two groups to receive 1000 mg/day l-carnitine or placebo (1000 mg starch) for 12 weeks. Results: l-Carnitine supplementation compared to the placebo showed a significant improvement in insulin [− 0.7 (− 7.3 to 4.0) vs. 0.7 (− 3.0 to 5.2); P = 0.001], homeostatic model assessment for insulin resistance [− 0.4 (− 1.7 to 1.1) vs. 0.0 (− 0.7 to 1.3); P = 0.002], quantitative insulin sensitivity check index (+ 0.01 ± 0.02 vs. − 0.01 ± 0.01; P = 0.02) and a non-significant change toward improvement in SHBG (+ 11.5 ± 40.2 vs. − 3.2 ± 40.2; P = 0.2). However, there was no significant differences between the two groups in serum levels of fasting plasma glucose, total cholesterol, triglyceride, low density lipoprotein-cholesterol and high density lipoprotein cholesterol (P > 0.05). Conclusion: 12-week l-carnitine supplementation in overweight or obese women with PCOS ameliorate insulin resistance, but has no effect on SHBG and lipid profile. Studies with higher dosages and duration of l-carnitine intake are required. The trial was registered on 30 December 2019 at Iranian Registry of Clinical Trials IRCT20191016045131N1. Trial registration: Registered on 30th December 2019 at Iranian Registry of Clinical Trials (IRCT20191016045131N1). [ABSTRACT FROM AUTHOR]

Background: Despite significant advances in the management of cardiovascular disease (CVDs), there is still a large burden of CVD in the world. The inclusion of functional foods in the diet may provide beneficial effects on CVD. Purple-black barberry due to its richness in anthocyanins and berberine has shown beneficial effects on cardiometabolic factors. We investigated the effects of barberry on plasma lipids as well as inflammatory biomarkers in subjects with cardiovascular risk factors. Methods: This was an 8-weeks, single-blinded, randomized controlled clinical trial that the participants were randomly assigned to a barberry (10 g/day dried barberry) or placebo group. At baseline and end of the study, plasma lipid profiles including total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), small-dense LDL-C (sd-LDL-C), non-HDL-C, and TC/HDL-C, as well as inflammatory biomarkers including C-reactive protein (CRP) and interleukin-6 (IL-6), were determined. An intention-to-treat analysis was performed. Results: Eighty-four participants were randomly assigned to study groups. The mean (± SD) participants' age was 54.06 ± 10.19 years. Body weight, body mass index (BMI), physical activity, and dietary intake were not different between the two groups at baseline and the end of the study. After adjusting for baseline values, we observed a significant decrease in plasma levels of TG, TC, LDL-C, sd-LDL-C, non-HDL-C, and TC/HDL-C (p < 0.001, p = 0.011, p = 0.015, p = 0.019, p = 0.004, and p = 0.039 respectively) as well as CRP (p = 0.020) in the barberry group compared to the placebo group. Conclusions: Our results indicate that purple-black barberry consumption decreases plasma levels of CRP and improves lipid profile in subjects with cardiovascular risk factors. Trial registration: This clinical trial was registered at ClinicalTrials.gov (NCT number: NCT04084847). [ABSTRACT FROM AUTHOR]

Background: In previous study, we found that coenzyme Q10 (CoQ10) improved glucolipid profile in dyslipidemic individuals, but the mechanism is not yet clear. Adipokines have been demonstrated to be vital targets of metabolic diseases. The hypothesis that adipokines mediate the association of CoQ10 on glucolipid metabolism needs to be further studied in human. Methods: In this randomized, double-blinded, placebo-controlled trial, 101 dyslipidemic individuals were administrated to 120 mg CoQ10 or placebo for 24 weeks. Anthropometric parameters, glucolipid profile, serum total adiponectin, leptin, and resistin were evaluated at baseline, week 12 and week 24. Results: CoQ10 treatment significantly increased serum adiponectin levels at week 12 (165 [0, 362] ng/mL, p < 0.001) and at week 24 (523 [0, 1056] ng/mL, p < 0.001]), which was significant different compared with placebo (p < 0.001). The increase of adiponectin was negative associated with decrease in index of homeostasis model assessment of insulin resistance (HOMA-IR, r = − 0.465, p = 0.001), triglyceride (TG, r = − 0.297, p = 0.047), and low-density lipoprotein cholesterol (LDL-c, r = − 0.440, p = 0.002) at week 24 only in CoQ10-treated group. Resistin was reduced by CoQ10 only at week 24 (− 1.19 [− 4.35, 0.00] ng/mL, p < 0.001), which was significant different compared with placebo (p < 0.001). Reduction of resistin was positively correlated with the change in HOMA-IR (r = 0.343, p = 0.021) and TG (r = 0.323, p = 0.030) at week 24 in CoQ10-treated group but not placebo group. Leptin was not influenced by CoQ10 treatment. Mediation analysis indicated that the improvement of HOMA-IR, TG and LDL-c by CoQ10 was mediated by adiponectin but not resistin. Conclusions: Our study shows that CoQ10 ameliorates glucolipid profile and adipokines dysfunction in dyslipidemic patients in 24 weeks' intervention. The beneficial effect of CoQ10 on glucolipid profile was mediated by adiponectin. Trial registration: ClinicalTrials.gov, NCT02407548. Registered on April 3, 2015, https://clinicaltrials.gov/ct2/show/NCT02407548. [ABSTRACT FROM AUTHOR]

Background Prenatal multiple micronutrient supplementation (MMS) and lipid-based nutrient supplementation (LNS) can improve birth outcomes relative to iron-folic acid supplementation (IFA); however, effects on child postnatal growth remain unclear. Objectives The aim was to compare the effect of prenatal MMS, medium-quantity LNS (MQ-LNS), and IFA on child growth up to 2 y of age. Methods We conducted a cluster randomized controlled trial of prenatal nutritional supplementation in Madarounfa, Niger. Villages were randomly assigned for pregnant women to receive IFA (17 villages, 1105 women), MMS (18 villages, 1083 women) or MQ-LNS (18 villages, 1144 women). Pregnant women received nutritional supplements weekly until delivery, and children were followed up monthly from 6-8 wk to 24 mo of age. We assessed the effect of prenatal MMS and MQ-LNS compared with IFA and the effect of prenatal MMS compared with MQ-LNS on child length-for-age z scores (LAZ), weight-for-age z scores (WAZ), and weight-for-length z scores (WLZ) at 24 mo of age using generalized linear models. In secondary analyses, we used mixed-effects models to assess the trajectories of anthropometric z scores longitudinally from 6–8 wk to 24 mo. Results Compared with IFA, MMS and MQ-LNS had no effect on child LAZ, WAZ, or WLZ at 24 mo of age (P > 0.05). Children in the MQ-LNS arm had significantly higher mid-upper arm circumference at 24 mo than children in the MMS arm: mean difference 0.50 cm (95% CI 0.10, 0.91 cm). WAZ and WLZ trajectories were more negative in the MQ-LNS arm compared with IFA and MMS, with lower z scores from 14 to 20 mo of age. However, WAZ and WLZ trajectories converged after 20 mo of age, and there were no differences by 24 mo of age. Conclusions Prenatal MMS and MQ-LNS had limited effect on anthropometric measures of child growth up to 24 mo of age as compared with IFA in rural Niger. [ABSTRACT FROM AUTHOR]

Background The effects of a dietary supplementation with the vegetable ω-3 α-linolenic acid (ALA) on cardiovascular homeostasis are unclear. In this context, it would be interesting to assess the effects of camelina oil. Objective This study aimed to assess the cardiovascular and metabolic effects of camelina oil in hypertensive patients with metabolic syndrome. Methods In a double-blind, placebo-controlled randomized study, treated essential hypertensive patients with metabolic syndrome received, during 6 mo, either cyclodextrin-complexed camelina oil containing ≈ 1.5 g ALA/d (n  = 40) or an isocaloric placebo (n  = 41), consisting of the same quantity of cyclodextrins and wheat starch. Anthropometric data, plasma lipids, glycemia, insulinemia, creatininemia, TBARs, high-sensitivity C-reactive protein, and n–3, n–6, and n–9 fatty acids in erythrocyte membranes were measured. Peripheral and central blood pressures, arterial stiffness, carotid intima-media thickness, and brachial artery endothelium-dependent flow-mediated dilatation (FMD) and endothelium-independent dilatation were assessed. Results Compared with placebo, camelina oil increased ALA (mean ± SD: 0 ± 0.04 compared with 0.08 ± 0.06%, P  <0.001), its elongation product EPA (0 ± 0.5 compared with 0.16 ± 0.65%, P  <0.05), and the n–9 gondoic acid (GA; 0 ± 0.04 compared with 0.08 ± 0.04%, P  <0.001). No between-group difference was observed for cardiovascular parameters. However, changes in FMD were associated with the magnitude of changes in EPA (r = 0.26, P  = 0.03). Compared with placebo, camelina oil increased fasting glycemia (–0.2 ± 0.6 compared with 0.3 ± 0.5 mmol/L, P  <0.001) and HOMA-IR index (–0.8 ± 2.5 compared with 0.5 ± 0.9, P  <0.01), without affecting plasma lipids, or inflammatory and oxidative stress markers. Changes in HOMA-IR index were correlated with the magnitude of changes in GA (r = 0.32, P  <0.01). Nutritional intake remained similar between groups. Conclusion ALA supplementation with camelina oil did not improve vascular function but adversely affected glucose metabolism in hypertensive patients with metabolic syndrome. Whether this adverse effect on insulin sensitivity is related to GA enrichment, remains to be elucidated. [ABSTRACT FROM AUTHOR]

Background: Despite advances in surgery and pharmacotherapy, there remains significant residual ischemic risk after coronary artery bypass grafting surgery.Methods: In REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial), a multicenter, placebo-controlled, double-blind trial, statin-treated patients with controlled low-density lipoprotein cholesterol and mild to moderate hypertriglyceridemia were randomized to 4 g daily of icosapent ethyl or placebo. They experienced a 25% reduction in risk of a primary efficacy end point (composite of cardiovascular death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina) and a 26% reduction in risk of a key secondary efficacy end point (composite of cardiovascular death, myocardial infarction, or stroke) when compared with placebo. The current analysis reports on the subgroup of patients from the trial with a history of coronary artery bypass grafting.Results: Of the 8179 patients randomized in REDUCE-IT, a total of 1837 (22.5%) had a history of coronary artery bypass grafting, with 897 patients randomized to icosapent ethyl and 940 to placebo. Baseline characteristics were similar between treatment groups. Randomization to icosapent ethyl was associated with a significant reduction in the primary end point (hazard ratio [HR], 0.76 [95% CI, 0.63-0.92]; P=0.004), in the key secondary end point (HR, 0.69 [95% CI, 0.56-0.87]; P=0.001), and in total (first plus subsequent or recurrent) ischemic events (rate ratio, 0.64 [95% CI, 0.50-0.81]; P=0.0002) compared with placebo. This yielded an absolute risk reduction of 6.2% (95% CI, 2.3%-10.2%) in first events, with a number needed to treat of 16 (95% CI, 10-44) during a median follow-up time of 4.8 years. Safety findings were similar to the overall study: beyond an increased rate of atrial fibrillation/flutter requiring hospitalization for at least 24 hours (5.0% vs 3.1%; P=0.03) and a nonsignificant increase in bleeding, occurrences of adverse events were comparable between groups.Conclusions: In REDUCE-IT patients with a history of coronary artery bypass grafting, treatment with icosapent ethyl was associated with significant reductions in first and recurrent ischemic events. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01492361. [ABSTRACT FROM AUTHOR]

Introduction: Recently, a modified intermittent fasting protocol was demonstrated to be able to maintain muscle mass and strength, decrease fat mass, and improve some inflammation and cardiovascular risk factors in healthy resistance-trained males after 2 months. The present study sought to investigate the long-term effects on these parameters. Methods : The experiment was a single-blind randomized study. Twenty healthy subjects were enrolled and underwent 12 months of either a time-restricted eating (TRE) diet or a normal diet (ND) protocol, along with resistance training. In the TRE protocol, subjects consumed their energy needs in three meals during an 8-h period of time each day (1 PM, 4 PM, and 8 PM). Subjects in the ND group also had three meals, which were consumed at 8 AM, 1 PM, and 8 PM. Groups were matched for kilocalories consumed and macronutrient distribution at baseline. Results : After 12 months of TRE, body mass, fat mass, insulin-like growth factor 1, and testosterone were significantly lower compared with ND. Moreover, inflammatory markers (interleukin 6, interleukin 1[beta], and tumor necrosis factor [alpha]), insulin sensitivity (fasting glucose, insulin, and homeostatic model assessment for insulin resistance index), and lipid profile (cholesterol, HDL, and LDL) significantly improved after TRE compared with ND. Finally, subjects in TRE spontaneously decreased their daily energy intake, whereas those in ND maintained their starting kilocalories per day. No adverse events were reported. Conclusions: Our results suggest that long-term TRE combined with a resistance training program is feasible, safe, and effective in reducing inflammatory markers and risk factors related to cardiovascular and metabolic diseases. [ABSTRACT FROM AUTHOR]

Background: Chronic kidney disease is associated with adverse outcomes among patients with established cardiovascular disease (CVD) or diabetes. Commonly used medications to treat CVD are less effective among patients with reduced kidney function.Methods: REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial) was a multicenter, double-blind, placebo-controlled trial that randomly assigned statin-treated patients with elevated triglycerides (135-499 mg/dL) who had CVD or diabetes and 1 additional risk factor to treatment with icosapent ethyl (4 g daily) or placebo. Patients from REDUCE-IT were categorized by prespecified estimated glomerular filtration rate (eGFR) categories to analyze the effect of icosapent ethyl on the primary end point (composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina) and key secondary end point (a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke).Results: Among the 8179 REDUCE-IT patients, median baseline eGFR was 75 mL·min-1·1.73 m-2 (range, 17-123 mL·min-1·1.73 m-2). There were no meaningful changes in median eGFR for icosapent ethyl versus placebo across study visits. Treatment with icosapent ethyl led to consistent reduction in both the primary and key secondary composite end points across baseline eGFR categories. Patients with eGFR <60 mL·min-1·1.73 m-2 treated with icosapent ethyl had the largest absolute and similar relative risk reduction for the primary composite end point (icosapent ethyl versus placebo, 21.8% versus 28.9%; hazard ratio [HR], 0.71 [95% CI, 0.59-0.85]; P=0.0002) and key secondary composite end point (16.8% versus 22.5%; HR 0.71 [95% CI, 0.57-0.88]; P=0.001). The numeric reduction in cardiovascular death was greatest in the eGFR <60 mL·min-1·1.73 m-2 group (icosapent ethyl: 7.6%; placebo: 10.6%; HR, 0.70 [95% CI, 0.51-0.95]; P=0.02). Although patients with eGFR <60 mL·min-1·1.73 m-2 treated with icosapent ethyl had the highest numeric rates of atrial fibrillation/flutter (icosapent ethyl: 4.2%; placebo 3.0%; HR 1.42 [95% CI, 0.86-2.32]; P=0.17) and serious bleeding (icosapent ethyl: 5.4%; placebo 3.6%; HR, 1.40 [95% CI, 0.90-2.18]; P=0.13), HRs for atrial fibrillation/flutter and serious bleeding were similar across eGFR categories (P-interaction for atrial fibrillation/flutter=0.92; P-interaction for serious bleeding=0.76).Conclusions: In REDUCE-IT, icosapent ethyl reduced fatal and nonfatal ischemic events across the broad range of baseline eGFR categories. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01492361. [ABSTRACT FROM AUTHOR]

The association between fish consumption and decreased risk of CVD is well documented. However, studies on health effects of fish consumption suggest that other components than n-3 PUFA have beneficial cardiometabolic effects, including effects on glucose metabolism. The aim of the present study was to investigate effects of salmon fish protein on cardiometabolic risk markers in a double-blind, randomised controlled parallel trial. We hypothesised that daily intake of a salmon fish protein supplement for 8 weeks would improve glucose tolerance in persons with increased risk of type 2 diabetes mellitus (T2DM). Our primary outcome measure was serum glucose (s-glucose) 2 h after a standardised oral glucose tolerance test. In total, eighty-eight adults with elevated s-glucose levels were randomised to 7·5 g of salmon fish protein/d or placebo, and seventy-four participants were included in the analysis. We found no significant effect of salmon fish protein supplementation on our primary outcome or other markers related to glucose tolerance, serum lipids, weight or blood pressure compared with placebo. The present study does not support the hypothesis that daily intake of a salmon fish protein supplement for 8 weeks improves glucose tolerance in persons with increased risk of T2DM. [ABSTRACT FROM AUTHOR]

Context: Studies in rodents and humans suggest that high-fructose corn syrup (HFCS)-sweetened diets promote greater metabolic dysfunction than sucrose-sweetened diets.Objective: To compare the effects of consuming sucrose-sweetened beverage (SB), HFCS-SB, or a control beverage sweetened with aspartame on metabolic outcomes in humans.Methods: A parallel, double-blinded, NIH-funded study. Experimental procedures were conducted during 3.5 days of inpatient residence with controlled feeding at a research clinic before (baseline) and after a 12-day outpatient intervention period. Seventy-five adults (18-40 years) were assigned to beverage groups matched for sex, body mass index (18-35 kg/m2), and fasting triglyceride, lipoprotein and insulin concentrations. The intervention was 3 servings/day of sucrose- or HFCS-SB providing 25% of energy requirement or aspartame-SB, consumed for 16 days. Main outcome measures were %hepatic lipid, Matsuda insulin sensitivity index (ISI), and Predicted M ISI.Results: Sucrose-SB increased %hepatic lipid (absolute change: 0.6 ± 0.2%) compared with aspartame-SB (-0.2 ± 0.2%, P < 0.05) and compared with baseline (P < 0.001). HFCS-SB increased %hepatic lipid compared with baseline (0.4 ± 0.2%, P < 0.05). Compared with aspartame-SB, Matsuda ISI decreased after consumption of HFCS- (P < 0.01) and sucrose-SB (P < 0.01), and Predicted M ISI decreased after consumption of HFCS-SB (P < 0.05). Sucrose- and HFCS-SB increased plasma concentrations of lipids, lipoproteins, and uric acid compared with aspartame-SB. No outcomes were differentially affected by sucrose- compared with HFCS-SB. Beverage group effects remained significant when analyses were adjusted for changes in body weight.Conclusion: Consumption of both sucrose- and HFCS-SB induced detrimental changes in hepatic lipid, insulin sensitivity, and circulating lipids, lipoproteins and uric acid in 2 weeks. [ABSTRACT FROM AUTHOR]

Objectives: Single sex after-school physical activity programs show potential to prevent unhealthy weight gain. The aim of this study was to assess the acceptability and potential efficacy of single-sex after-school physical activity programs for overweight and at-risk children from low-income communities. Design: 7-month, 2-arm parallel-group, RCT, conducted at an elementary school in a disadvantaged area in Wollongong, Australia (March-November 2010). Methods: 20 boys and 17 girls were randomized to intervention (PA) or active comparison groups (HL). Primary outcomes included implementation, acceptability, percentage body fat and BMI z-score. Results: The PA programs were acceptable with high implementation and enjoyment rates. At 7 months postintervention girls in the PA group displayed greater changes in percentage body fat (adjust diff. = -1.70, [95% CI -3.25, -0.14]; d = -0.83) and BMI z-score (-0.19 [-0.36, -0.03]; d= -1.00). At 7 months boys in the PA group showed greater changes in waist circumference (-3.87 cm [-7.80, 0.15]; d= -0.90) and waist circumference z-score (-0.33 [-0.64, -0.03]; d= -0.98). For both boys' and girls' PA groups, changes in adiposity were not maintained at 12-month follow-up. Conclusions: Single-sex after-school physical activity programs are acceptable and potentially efficacious in preventing unhealthy weight gain among overweight and at-risk children. However improvements are hard to sustain once programs finish operating. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the impact of the Dietary Approaches to Stop Hypertension (DASH) diet on glycaemic control and consumption of processed (PF) and ultraprocessed (UPF) foods in pregnant women with pre-gestational diabetes mellitus (PGDM). This is a randomised, controlled, single-blind clinical trial with forty-nine adult women with PGDM, followed at a public maternity hospital in Rio de Janeiro, Brazil. The control group (CG) received a standard diet consisting of 45–55 % of the total energy intake of carbohydrates, 15–20 % of proteins and 25–30 % of lipids. The DASH group (DG) received an adapted DASH diet, which did not differ from the standard diet in the percentage of macronutrients, but had higher contents of fibre, unsaturated fats and minerals such as Ca, Mg and K; and lower contents of Na and saturated fats than the standard diet. In the analysis by protocol, the DG presented a higher incidence of glycaemic control after 12 weeks of intervention (57·1 v. 8·3 %, P = 0·01, moderate effect size) and a lower mean consumption of UPF (−9·9 %, P = 0·01) compared with the CG. There was no statistically significant difference in fasting and postprandial blood glucose concentrations, or in the consumption of PF between the groups (P > 0·05). The DASH diet may be a strategy for glycaemic control in pregnant women with PGDM, favouring the adoption of a nutritionally adequate diet with lower consumption of UPF. Further studies are needed to investigate the effect of the DASH diet on glycaemic profile, and maternal and perinatal outcomes in women with PGDM. [ABSTRACT FROM AUTHOR]

Background: Diabetes is a chronic disease and the prevalence of it is rapidly increasing. Recently, the use of natural products in chronic diseases such as diabetes has gained more attention. Chlorella, a single-celled green alga, is one of them. There have been some studies on the effects of chlorella supplementation in chronic diseases such as NAFLD, prediabetes, and diabetic mice, but none of them examined the effects of chlorella in patients with T2DM. The present study was designed to evaluate the effects of chlorella supplementation on glycemic control, lipid profile, and anthropometric indices in type 2 diabetic patients. Methods: This study is a double-blind, randomized controlled trial. 84 patients with T2DM assigned into two groups, receiving 1500 mg/day C. vulgaris or placebo for 8 weeks. Anthropometric information, blood pressure, 24-h food intake recall, and blood samples were collected at the beginning and end of the study to determine the changes of FBS, HbA1c, insulin concentration, insulin resistance, and lipid profile. Results: None of the variables investigated in this study showed a significant change after 8 weeks of intervention with C. vulgaris. Conclusion: According to the findings of this study, supplementation with C. vulgaris with a dosage of 1500 mg/day for 8 weeks, does not improve the anthropometric measurements, glycemic status, and lipid profile as well. Thus, it cannot be considered as a complementary therapeutic approach to common medications at this dosage and duration. However, future studies with a higher dosage of C. vulgaris and more prolonged than 8 weeks are needed to be done. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to investigate the effects of vitamin K2 supplementation in the form of menaquinone-7 (MK-7) on glucose, insulin, and lipid metabolism in patients with type 2 diabetes mellitus (T2DM). Methods: In this double-blinded, placebo-controlled, randomized trial, 68 insulin-independent people with diabetes received either 180 µg MK-7 twice a day or placebo for 12 weeks. We assessed fasting plasma glucose (FPG) and insulin concentrations (primary outcomes), glycated hemoglobin (HbA1c), insulin sensitivity indices, and lipid profiles (secondary outcomes) at baseline and end of the trial. Results: At the end of the trial, FPG (effect size (ES) = − 0.68; p-adjusted = 0.031) and HbA1c (ES = − 0.36; p-adjusted = 0.004) were significantly lower in the vitamin K2 group compared with the placebo at the end of the trial. The number of participants achieved the target levels of glycemic control based on FPG, and HbA1c concentrations were significantly higher in the vitamin K2 group compared to the placebo group. Insulin concentrations (ES = − 0.29; p = 0.019) and homeostatic model assessment for insulin resistance (HOMA-IR) significantly decreased in the vitamin K2 group (ES = − 0.29; p = 0.019) compared to baseline, but their values were not significantly different compared to the placebo group at the end of the trial. No significant variation was observed in lipid profiles. Conclusion: Daily intake of 360 µg Vitamin K2 in the form of MK-7 for 12-weeks reduces FPG and HbA1c in patients with T2DM but does not have a lipid-lowering effect. [ABSTRACT FROM AUTHOR]

Background: Prediabetes is a high-risk state for developing diabetes at an annual rate of 5%-10%. Early intervention can prevent further complications, including metabolic syndrome. Bisphosphonates are commonly used for osteoporotic postmenopausal women. The purpose of this study was to assess the effects of bisphosphonates on lipid profile including triglyceride (TG), total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) of prediabetic postmenopausal women with osteopenia. Materials and Methods: In this triple-blind randomized controlled trial, sixty prediabetic, postmenopausal women with sufficient Vitamin D and osteopenia, aged 45-60 years, were randomly enrolled in two groups of intervention (receiving 70-mg alendronate for 12 weeks [duration for maximum metabolic effect of bisphosphonates], n = 30) and control (receiving placebo, n = 30) according to a randomized block procedure of size 2 and 1:1 allocation ratio. The primary outcome of the study, the lipid profile, was evaluated before and after the interventions. The effect of the intervention was assessed using analysis of covariance. Results: The lipid profiles showed no significant differences to the mean values at the baseline in both the groups (all P > 0.05). At the end of the study, the differences between the groups were not significant for 25(OH) D3 (mean difference: -11.09, 95% confidence interval: -32.43-10.25), T (4.19, -30.58-38.97), cholesterol (8.13, -13.07-29.33), LDL-cholesterol (5.07, -10.18-20.31), and HDL-cholesterol (-0.86, -6.04-4.31) when the baseline values and confounders were adjusted (all P > 0.05). Conclusion: No statistically significant difference was detected in the serum lipid profile of prediabetic postmenopausal women with osteopenia as a result of alendronate intervention. More studies with larger sample sizes and longer intervention periods are recommended. [ABSTRACT FROM AUTHOR]

A glyceride mixture of monoglyceride, diglyceride and TAG increases solubilisation and enhances emulsification of n-3 fatty acid (FA)-containing lipids in the stomach. This allows for better access of digestive enzymes, pivotal for the release of bioactive n-3 FA. The objective was to compare the effect of a glyceride formulation and an ethyl ester formulation of EPA + DHA on concentrations of EPA and DHA in plasma following single dosing. We conducted a double-blind crossover trial in which twenty healthy adults aged 50–70 years consumed a single dose (2·8 g EPA + DHA) of each EPA + DHA formulation without a meal in random order separated by a 2-week washout period. EPA and DHA were measured in plasma total lipid over the following 12 h. EPA and DHA in plasma total lipid increased over 12 h with both formulations. A 10-fold greater Δ concentration of EPA, 3-fold greater Δ concentration of DHA and 5-fold greater Δ concentration of EPA + DHA were seen with the glyceride-EPA + DHA. The time at which the maximal concentrations of n-3 FA occurred was 4 h earlier for EPA, 1 h earlier for DHA and 2 h earlier for EPA + DHA when consuming glyceride-EPA + DHA. A mixture of monoglyceride, diglyceride and TAG results in greater and faster incorporation of EPA and DHA into blood plasma lipid in the absence of a fatty meal. This may provide benefit to individuals on a low-fat diet or with digestive impairments and could result in greater efficacy in clinical trials using n-3 FA. [ABSTRACT FROM AUTHOR]

Metabolic syndrome (MetS) represents a cluster of metabolic abnormalities that include hypertension, central obesity, insulin resistance, and dyslipidemia and is strongly associated with an increased risk of diabetes, cardiovascular diseases (CVD), and all-cause mortality. Early diagnosis is important to employ lifestyle and risk factor modification. Existing therapies are limited. Studies report positive effect of omega-3 fatty acids (ω-3FA) on symptoms of metabolic syndrome. The present study was undertaken to evaluate the effect of ω-3FA alone and in combination with proprietary chromium complex (PCC) on endothelial function in subjects with metabolic syndrome. In this randomized, double-blind, parallel-group study, subjects were enrolled into the study after ethics committee (EC) approval and informed consent. Eligible subjects were randomized to receive ω-3FA concentrate 2000 mg (Group A-18 subjects), ω-3FA concentrate 2000 mg + PCC200 mcg (Group B-19 subjects), and ω-3FA concentrate 2000 mg + PCC400 mcg (Group C-21 subjects) daily for 12 weeks. Endothelial dysfunction as measured by reflection index (RI), biomarkers of oxidative stress (NO, MDA, and glutathione), and inflammation (hsCRP, endothelin-1, ICAM-1, and VCAM-1) were evaluated at baseline, 4, and 12 weeks. Lipid-profile and platelet-aggregation tests were performed at baseline and 12 weeks. Adverse drug reactions were recorded. Compliance was assessed by pill count method. GraphPad Prism8 was used for statistical analysis. Significant changes were seen from 4 weeks onwards in all the parameters evaluated. Significant improvement in RI% (mean ± SD = −2.56 ± 0.77 to −3.27 ± 0.67-group A, −2.33 ± 0.76 to 4.72 ± 0.79-group B; −2.39 ± 1.13 to 6.46 ± 1.00-group C) was seen at 12 weeks. Significant improvement in biomarkers of oxidative stress and inflammation was seen with all the treatment groups. Similarly, significant improvement in lipid profile was seen in group B and group C, while group A showed change in HDL, VLDL, and TG. Group C demonstrated the best response in the parameters evaluated. Three patients in group C reported gastrointestinal adverse events, which resolved spontaneously; none stopped the therapy. So, the addition of PCC to ω-3FA may prove to have beneficial effect in reducing cardiovascular morbidity in MetS patients. [ABSTRACT FROM AUTHOR]

Background: Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age. This study was designed to investigate the effects of melatonin and/or magnesium supplementation on metabolic profile and levels of sex hormones in PCOS women. Methods: In an 8-week randomized double-blind placebo-controlled trial, 84 subjects with PCOS aged 18-40 years were randomly assigned based on the random block procedure to take magnesium, melatonin, magnesium plus melatonin, and placebo. Fasting blood samples were obtained at the beginning and end of the study. Results: After intervention, the mean Pittsburg Sleep Quality Index score decreased significantly in both co-supplementation and melatonin groups (P < 0.001). Magnesium supplementation in combination with melatonin resulted in a significant greater decrease in testosterone concentrations compared with the placebo (P < 0.05). Co-supplementation of magnesium-melatonin had significantly reduced serum insulin levels (geometric means difference: -1.11 (mIU/mL) (percent change: -15.99)), homeostasis model of assessment-insulin resistance (HOMA-IR) (-0.28 (-18.66)), serum cholesterol (mean difference: -16.08 (mg/dl) [95% CI -24.24, -7.92]), low-density lipoprotein cholesterol (LDL-C) -18.96 (mg/dl) [-28.73, -9.20]) and testosterone levels (-0.09 (ng/ml) (-25.00)), as compared to the baseline values (P < 0.05). An increase in serum high-density lipoprotein cholesterol (HDL-C) levels was also observed following the administration of the melatonin alone (2.76 (mg/dl) [0.57, 4.95]) or in combination with magnesium (2.19 (mg/dl) [0.61, 3.77]) (P < 0.05). Conclusions: Co-supplementation with magnesium and melatonin had beneficial effects on sleep quality and total testosterone. Additionally, melatonin supplementation alone was found to be associated with a significant reduction in PSQI score. Moreover, combined melatonin and magnesium supplementation was more effective in improving serum levels of cholesterol, LDL-C, HDL-C and insulin, and HOMA-IR. [ABSTRACT FROM AUTHOR]

Purpose: Overweight and obesity are associated with many health problems, including cardiovascular disease (CVD). Evidence from previous studies has shown that extracts from olive leaves rich in olive phenolics are able to positively affect CVD risk factors, such as high blood pressure and dyslipidemia. The aim of this study was to investigate the effect of 8-week olive leaf extract (OLE) administration on blood lipid profiles in overweight/obese subjects with mildly elevated cholesterol levels. Methods: In this randomized, double-blind, placebo-controlled study, 77 healthy adult overweight/obese subjects (aged 56 ± 10 years and BMI 29.0 ± 2.7 kg/m2) with total cholesterol levels of 5.0–8.0 mmol/L (5.9 ± 0.7 mmol/L) were randomly assigned to receive 500 mg of OLE (n = 39) or placebo (n = 38) for 8 weeks. In total, 74 subjects completed the entire study protocol. At baseline, after 4 weeks, and after 8 weeks of supplementation, blood lipid profiles, oxidized low-density lipoprotein (oxLDL), blood pressure, glucose, and insulin levels were assessed. In addition, liver function parameters were measured at baseline and after 8 weeks. Results: OLE supplementation did not significantly affect blood lipid levels after 4 weeks or after 8 weeks compared to placebo (all p > 0.05). For oxLDL, blood pressure, glucose, and insulin levels and liver function parameters, also no statistically significant differences were found between the two intervention groups (all p > 0.05). Conclusions: Blood lipid profiles were not significantly affected by 8 weeks OLE supplementation in overweight/obese subjects with mildly elevated cholesterol levels. Trial registered: The trial has been registered at ClinicalTrials.gov (NCT02990637). [ABSTRACT FROM AUTHOR]