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Kevin C Maki,1 Tia M Rains,1 Arianne L Schild,1 Mary R Dicklin,1 Keigan M Park,2 Andrea L Lawless,1 Kathleen M Kelley1 1Biofortis Clinical Research, Addison, IL, USA; 2Dairy Research Institute/National Dairy Council, Rosemont, IL, USA Objective: This randomized crossover trial assessed the effects of 5 weeks of consuming low-fat dairy (one serving/day each of 1% fluid milk, low-fat cheese, and low-fat yogurt) versus nondairy products (one serving/day each of apple juice, pretzels, and cereal bar) on systolic and diastolic blood pressures (SBP and DBP), vascular function (reactive hyperemia index [RHI] and augmentation index), and plasma lipids. Methods: Patients were 62 men and women (mean age 54.5 years, body mass index 29.2 kg/m2) with prehypertension or stage 1 hypertension (mean resting SBP/DBP 129.8 mmHg/80.8 mmHg) while not receiving antihypertensive medications. A standard breakfast meal challenge including two servings of study products was administered at the end of each treatment period. Results: Dairy and nondairy treatments did not produce significantly different mean SBP or DBP in the resting postprandial state or from premeal to 3.5 hours postmeal (SBP, 126.3 mmHg versus 124.9 mmHg; DBP, 76.5 mmHg versus 75.7 mmHg), premeal (2.35 versus 2.20) or 2 hours postmeal (2.33 versus 2.30) RHI, and premeal (22.5 versus 23.8) or 2 hours postmeal (12.4 versus 13.2) augmentation index. Among subjects with endothelial dysfunction (RHI ≤ 1.67; n = 14) during the control treatment, premeal RHI was significantly higher in the dairy versus nondairy condition (2.32 versus 1.50, P = 0.002). Fasting lipoprotein lipid values were not significantly different between treatments overall, or in subgroup analyses. Conclusion: No significant effects of consuming low-fat dairy products, compared with low-fat nondairy products, were observed for blood pressures, measures of vascular function, or lipid variables in the overall sample, but results from subgroup analyses were consistent with the hypothesis that dairy foods might improve RHI in those with endothelial dysfunction. Keywords: blood pressure, dairy, endothelial function, hypertension, lipids

Kevin C Maki1, Mary R Dicklin1, Michael H Davidson2, Patrick D Mize3, Krishnaji R Kulkarni31Provident Clinical Research/Biofortis North America, Glen Ellyn, IL, 2The University of Chicago Pritzker School of Medicine, Chicago, IL, 3Atherotech, Birmingham, AL, USAObjective: Progression of carotid intima-media thickness (CIMT) is a surrogate indicator for the early stages of atherosclerosis.Methods: The study investigated relationships between baseline lipoprotein cholesterol, triglyceride (TG), and apolipoprotein (Apo) B levels assessed with density gradient ultracentrifugation (DGU) and progression of posterior wall common CIMT in men (45–75 years of age) and women (55–74 years of age) in the control arm of a clinical trial. Participants had baseline posterior wall CIMT 0.7–2.0 mm, without significant stenosis. CIMT was assessed using B-mode ultrasound at baseline, and 12 and ~18 months. A DGU cholesterol panel that assessed the major lipoprotein classes and subclasses, plus triglycerides, lipoprotein (a) cholesterol, low-density lipoprotein (LDL) peak time (inversely related to LDL particle density), and Apo B were performed on fasting baseline samples. Apo B was also measured using an enzyme linked immunosorbent assay.Results: Baseline CIMT was inversely associated (P < 0.001) with CIMT progression. After adjustment for baseline CIMT, significant predictors of posterior wall CIMT progression in linear regression analyses included LDL peak time (inverse, P = 0.045), total high-density lipoprotein cholesterol (HDL-C) (inverse, P = 0.001), HDL2-C (inverse, P = 0.005), HDL3-C (inverse, P = 0.003), very low-density lipoprotein (VLDL)-C (P = 0.037), and VLDL1+2-C (P = 0.016).Conclusion: These data indicate that DGU-derived indicators of the “atherogenic lipoprotein phenotype,” including increased TG-rich lipoprotein cholesterol, lower HDL-C and HDL-C subfractions, and a greater proportion of LDL-C carried by more dense LDL particles, are associated with CIMT progression in men and women at moderate risk for coronary heart disease.Keywords: carotid intima media thickness, density gradient ultracentrifugation, coronary heart disease risk, lipids, atherosclerosis, lipoprotein subfractions

This randomized, placebo-controlled, crossover trial assessed the lipid-altering efficacy of a dietary supplement (tablet form) providing 1.8 g/day free (non-esterified) plant sterols and stanols versus placebo for 6 weeks as part of a therapeutic lifestyle changes (TLC) diet in 32 men and women with primary hypercholesterolaemia. Mean ± SE baseline (end of a 5-week TLC diet lead-in) lipid concentrations (mmol/l) were total cholesterol (TC), 5.88 ± 0.08; non-high-density lipoprotein cholesterol (non-HDL-C), 4.71 ± 0.09; low-density lipoprotein cholesterol (LDL-C), 4.02 ± 0.08; HDL-C, 1.17 ± 0.06 and triglycerides (TGs), 1.51 ± 0.12. Differences from control in responses (plant sterol/stanol - control) were significant (p < 0.05) for LDL-C ( - 4.9%), non-HDL-C ( - 3.6%) and TC ( - 2.8%). HDL-C and TG responses were not significantly different between treatment conditions. These results indicate that 1.8 g/day free plant sterols/stanols administered in a tablet produced favourable lipoprotein lipid changes in men and women with hypercholesterolaemia. [ABSTRACT FROM AUTHOR]

This study evaluated the effects of 2 levels of intake of high-amylose maize type 2 resistant starch (HAM-RS2) on insulin sensitivity (S(I)) in participants with waist circumference ≥89 (women) or ≥102 cm (men). Participants received 0 (control starch), 15, or 30 g/d (double-blind) of HAM-RS2 in random order for 4-wk periods separated by 3-wk washouts. Minimal model S(I) was assessed at the end of each period using the insulin-modified i.v. glucose tolerance test. The efficacy evaluable sample included 11 men and 22 women (mean ± SEM) age 49.5 ± 1.6 y, with a BMI of 30.6 ± 0.5 kg/m2 and waist circumference 105.3 ± 1.3 cm. A treatment main effect (P = 0.018) and a treatment × sex interaction (P = 0.033) were present. In men, least squares geometric mean analysis for S(I) did not differ after intake of 15 g/d HAM-RS2 (6.90 × 10⁻⁵ pmol⁻¹ · L⁻¹ × min⁻¹) and 30 g/d HAM-RS2 (7.13 × 10⁻⁵ pmol⁻¹ · L⁻¹ × min⁻¹), but both were higher than after the control treatment (4.66 × 10⁻⁵ pmol⁻¹ · L⁻¹ × min⁻¹) (P < 0.05). In women, there was no difference among the treatments (overall least squares ln-transformed mean ± pooled SEM = 1.80 ± 0.08; geometric mean = 6.05 × 10⁻⁵ pmol⁻¹ · L⁻¹ × min⁻¹). These results suggest that consumption of 15-30 g/d of HAM-RS2 improves S(I) in men. Additional research is needed to understand the mechanisms that might account for the treatment × sex interaction observed. [ABSTRACT FROM AUTHOR]

Objective: This randomized, double-blind crossover trial evaluated the effects of a type 3 novel resistant starch (RS) versus wheat bran (WB) on faecal weight, frequency, and consistency in healthy adults.Methods: Following a 14-day baseline period during which subjects (n=14) consumed low-fibre (<2 g) test products, participants were assigned to receive 25 g RS or WB fibre daily for 14 days, then crossed over to the opposite treatment after a 7-day washout.Results: Daily faecal output increased from 128.8+/-68.7 g at baseline to 164.2+/-88.4 g with RS and 194.5+/-92.0 g with WB (both P<0.02 versus baseline). No significant differences among the three conditions were observed for bowel movement frequency. Faecal consistency ratings were increased with WB (P=0.001), but unchanged with RS.Conclusions: Dietary RS and WB increase faecal output in healthy adults. [ABSTRACT FROM AUTHOR]

OBJECTIVE: High-viscosity hydroxypropylmethylcellulose (HV-HPMC) is a modified cellulose fiber that produces a viscous gel in the gastrointestinal tract. Clinical trials demonstrate that consumption of HV-HPMC significantly lowers cholesterol, but limited information has been available on the influence of HV-HPMC on postprandial insulin and glucose responses. The objective of this investigation was to assess the influence of HV-HPMC on postprandial glucose and insulin responses in overweight and obese men and women. RESEARCH DESIGN AND METHODS: Participants were 31 overweight or obese men and women without diabetes who underwent three breakfast meal tests in random order, separated by > or = 72 h. Test meals containing 75 g carbohydrate plus 4 or 8 g HV-HPMC or control meals containing 8 g cellulose were delivered in a double-blind fashion. RESULTS: Peak glucose was significantly lower (P < 0.001) after both HV-HPMC-containing meals (7.4 mmol/l [4 g] and 7.4 mmol/l [8 g]) compared with the control meal (8.6 mmol/l). Peak insulin concentrations and the incremental areas for glucose and insulin from 0 to 120 min were also significantly reduced after both HV-HPMC doses versus control (all P < 0.01). CONCLUSIONS: These findings indicate that HV-HPMC consumption reduces postprandial glucose and insulin excursions, which may favorably alter risks for diabetes and cardiovascular disease. [ABSTRACT FROM AUTHOR]

Objective: This study evaluated the effects of colesevelam on plasma lipids. aortic plaque area, and reverse cholesterol transport enzymes and genes in a rabbit model of atherosclerosis. Methods: Thirty New Zealand white rabbits were fed standard chow for 1 week, placed on a 0,5% cholesterol diet for 2 weeks, then randomized equally to receive either the 0.5% cholesterol diet (control) or the 0.5% cholesterol diet with 1.5 g of colesevelam for 11 weeks. Serum total cholesterol and high density lipoprotein cholesterol concentrations and lecithin-cholesterol acythansferase (LCAT) activity were measured before randomization and at treatment endpoint. Rabbits were killed and plaque area was measured in one aorta segment. Gene expression was measured by reverse transcription polymerase chain reaction in liver RNA extracts. Results: Colesevelam markedly reduced the circulating cholesterol concentration and decreased plaque area by 81% compared with controls (P<0.001). LCAT fractional rate was markedly increased versus controls (12.6% and 0.2%. respectively: P<0.001). Colesevelam enhanced fecal cholesterol concentrations more than two-fold. Colesevelam significantly increased hepatic gene expression for scavenger receptor type BI, apolipoprotein A1, LCAT. cholesterol ester transfer protein, cholesterol 7-[alpha]-hydroxylase (CYP7A1), low-density lipoprotein receptor, and liver X receptor (LXR). Conclusions: In cholesterol-fed rabbits, colesevelam reduced atherosclerosis through cholesterol lowering and potentially by enhancing reverse cholesterol transport, mediated by changes in LXR-regulated proteins. [ABSTRACT FROM AUTHOR]

During his Banting lecture at the American Diabetes Association's (ADA's) annual scientific sessions in 1988, Dr. Gerald Reaven coined the term 'Syndrome X' to refer to a constellation of metabolic abnormalities that were often found together in the same individual. He proposed that the central feature of Syndrome X is insulin resistance, an impaired ability for a given concentration of insulin in the blood to reduce blood glucose and free fatty acid concentrations. Persons with insulin resistance are also characterized by a group of other disturbances, including increased triglycerides; depressed high-density lipoprotein (HDL) cholesterol; elevated blood pressure; small, dense low-density lipoprotein (LDL) particles; hemostatic disturbances; and central obesity. Syndrome X is a very common condition, affecting 25% or more of young adults and more than half of those over 55 years of age. Thus, the potential impact of Syndrome X on public health is enormous. Lifestyle modification, mainly increased physical activity, loss of excess body fat, smoking cessation, and dietary modification, is the key to successful prevention and management of Syndrome X. Copyright © 2001 by Aspen Publishers, Inc. [ABSTRACT FROM AUTHOR]

A predominance of small, dense low-density lipoprotein (LDL) particles (subclass pattern B) has been associated with a 2- to threefold increase in coronary heart disease risk. Recently, it has been reported that LDL subclass pattern B is associated with hyperfibrinogenemia, which is also a coronary heart disease risk factor. The present study examined the relation between hyperfibrinogenemia and LDL subclass pattern in 258 postmenopausal women. A significant univariate correlation was observed between the concentration of cholesterol carried in small, dense LDL particles and plasma fibrinogen concentration (r = 0.17, p = 0.01). The prevalence of LDL subclass pattern B was 41.9% in the highest fibrinogen tertile, compared with 27.9% and 24.4% in the first and second tertiles, respectively (global chi-square 6.8, p = 0.03). The crude odds ratio (OR) for LDL subclass pattern B among women in the highest fibrinogen tertile, compared with the lower tertiles, was 2.03 (95% confidence interval [CI] 1.18 to 3.51, p = 0.01). After adjustment for age and plasma lipids (log(e) triglycerides, LDL cholesterol, and high-density lipoprotein cholesterol), the OR was 2.14 (95% CI 1.17 to 3.96, p = 0.01). Further adjustment for hematocrit, indicators of carbohydrate homeostasis, body mass index, waist circumference, and several variables related to lifestyle did not attenuate this association (OR 2.56, 95% CI 1.27 to 5.27, p = 0.01). These data suggest that hyperfibrinogenemia and LDL subclass pattern B may be 2 components of a common syndrome and suggest that hyperfibrinogenemia may contribute to the increased coronary heart disease risk associated with LDL subclass pattern B. [ABSTRACT FROM AUTHOR]

Hydroxypropylmethylcellulose (HPMC) is a food gum having several structural and functional properties in common with hypocholesterolemic soluble fibers. The safety and cholestero-lowering efficacy of HPMC, incorporated into a National Cholesterol Education Program Step I diet, was compared with placebo in patients with mild to moderate hypercholesterolemia. After an 8-week National Cholesterol Education Program Step I dietary lead-in phase, 160 patients with low-density lipoprotein (LDL) cholesterol between 130 and 200 mg/dl and triglycerides <300 mg/dl were randomized to placebo, 2.5, 5.0, or 7.5 g/day of HPMC for a 6-week treatment period. Patients returned to the clinic every 2 weeks for lipid measurements and safety assessments. HPMC significantly lowered total, LDL, and non-high-density lipoprotein (HDL) cholesterol. LDL cholesterol concentrations (average of weeks 4 and 6) decreased by 3.0% (4.9 mg/dl), 5.9% (10.3 mg/dl), 12.1% (20.4 mg/dl), and 11.7% (20.3 mg/dl) from baseline levels in the placebo and 2.5, 5.0, and 7.5 g/day HPMC treatment groups, respectively. Statistically significant (p<0.05) reductions in LDL cholesterol were observed in the 5.0 and 7.5 g/day HPMC groups compared with placebo and 2.5 g/day HPMC treatment groups. Total and non-HDL cholesterol responses paralleled those of LDL cholesterol. There were no significant differences between the treatment groups in HDL cholesterol or triglyceride responses, incidence of adverse experiences, or gastrointestinal-related adverse experiences. These results suggest that HPMC is a well-tolerated and effective adjunct to diet for lowering LDL cholesterol in patients with mild to moderate hypercholesterolemia. [ABSTRACT FROM AUTHOR]

Seven subjects with chronic paralysis due to spinal cord injury completed a series of experiments to 1) determine and compare the metabolic cost of propelling the Handbike and Rowcycle, and 2) evaluate the potential of these upper body-powered devices for improving the cardiorespiratory fitness of persons with lower limb disabilities. Mean intrasubject differences between the Handbike and Rowcycle rides for heart rate, minute ventilation, oxygen uptake, and net locomotive energy cost were small and did not reach statistical significance for any of the ride conditions. Lower net locomotive energy cost (greater economy) during a 5.5 mi-hr(-1) ride condition predicted vehicle preference in all cases (P=0.008). The range of values for percent peak oxygen uptake suggests that all but one of the subjects were able to utilize either vehicle at an intensity sufficient for improving and maintaining cardiorespiratory fitness without undue fatigue. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effects of prescription omega-3-acid ethyl esters on non-high-density lipoprotein cholesterol (HDL-C) levels in atorvastatin-treated patients with elevated non-HDL-C and triglyceride levels.Patients and Methods: This study, conducted between February 15, 2007, and October 22, 2007, randomized patients with elevated non-HDL-C (>160 mg/dL) and triglyceride (>or=250 mg/dL and Results: Prescription omega-3-acid ethyl esters plus atorvastatin, 10, 20, and 40 mg/d, reduced median non-HDL-C levels by 40.2% vs 33.7% (P<.001), 46.9% vs 39.0% (P<.001), and 50.4% vs 46.3% (P<.001) compared with placebo plus the same doses of atorvastatin at the end of 8, 12, and 16 weeks, respectively. Prescription omega-3-acid ethyl esters plus atorvastatin also reduced median total cholesterol, triglyceride, and very low-density lipoprotein cholesterol levels and increased HDL-C levels to a significantly greater extent than placebo plus atorvastatin. Percent changes from baseline low-density lipoprotein-cholesterol, apolipoprotein A-I, and apolipoprotein B levels were not significantly different between groups at the end of the study.Conclusion: Prescription omega-3-acid ethyl esters plus atorvastatin produced significant improvements in non-HDL-C and other lipid parameters in patients with elevated non-HDL-C and triglyceride levels. [ABSTRACT FROM AUTHOR]

Purpose of Review: Statins are first-line pharmacotherapy for the treatment of elevated low-density lipoprotein cholesterol and are generally well-tolerated. However, some patients may experience statin-associated muscle symptoms (SAMS). This paper reviews recommendations for identification and management of patients with SAMS., Recent Findings: The National Lipid Association and other professional societies have issued guidance to assist clinicians in identifying and managing patients with partial or complete statin intolerance. The most common reason for intolerance is SAMS. This review discusses strategies to achieve therapeutic objectives for atherogenic lipoprotein management in patients with SAMS. Many patients who experience SAMS can tolerate some degree of statin therapy and non-statin medications are available as adjunctive or alternative treatments. With a thorough clinician-patient discussion and shared decision-making, a treatment plan can be identified to achieve therapeutic objectives and reduce the risk of atherosclerotic cardiovascular disease., Competing Interests: Declarations Human and Animal Rights and Informed Consent This article does not contain any studies with human or animal subjects performed by any of the authors. Competing Interests Financial interests: KCM is an employee of Midwest Biomedical Research and has received consulting fees and/or research grant support from 89Bio; Acasti Pharma; Beren Pharmaceuticals; Eli Lilly & Co.; NewAmsterdam Pharma; Matinas BioPharma; NorthSea Therapeutics; Novo Nordisk; Pharmavite. CFK is an employee of Midwest Biomedical Research, which has received research funding and consulting fees from food and pharmaceutical companies; no other disclosures. MKC is a sub-investigator for clinical trials funded by Novartis and Eli Lilly and Company and a consultant and advisory board member for Regeneron and Novartis. TAJ received consulting fees from Amgen, Regeneron, Astra Zeneca, and Novartis., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: The purpose of this study was to assess the impact of bitter melon extract supplementation on glycemia in individuals with prediabetes., Methods: This was a 12-week randomized, parallel, placebo-controlled study where 75 adults with prediabetes were randomly allocated into the low-dose bitter melon (300 mg/day) ( n  = 26), high-dose bitter melon (600 mg/day) ( n  = 24), or control ( n  = 25) groups., Results: At baseline and weeks 6 and 12, anthropometrics were measured, and fasting blood samples were obtained. The high-dose (1.05% ± 10.2%) and low-dose bitter melon (3.35% ± 13.2%) groups showed smaller increases in blood glucose levels at 12 wk, compared to the control group (11.0% ± 16.3%) ( p  < 0.05). A subgroup analysis of participants with age ≥ the median demonstrated a greater reduction in glycated hemoglobin at 12 wk in the high-dose bitter melon group (median change: -0.20%; IQRL: -0.20%, -0.05%) vs. the control group (median change: 0.00%; IQRL: -0.10%, 0.20%) ( p  = 0.017). Compliance with the interventions was >95%, and the study products were tolerated well., Conclusion: The bitter melon extract may help maintain a healthy level of glucose in adults with prediabetes.

Protein is the most thermogenic macronutrient, but it is unclear how different amounts and types of protein impact diet-induced thermogenesis (DIT). The purpose of this meta-analysis was to compare the impact of isocaloric meals/diets containing different amounts or types of protein on energy metabolism. Databases were searched in June 2024 for studies that compare DIT or total daily energy expenditure (TDEE) in response to isocaloric acute meals or longer-term diets containing different amounts or types of protein. After identifying 3894 records, 52 studies were included. Standardized mean difference (SMD) estimates and 95% confidence intervals (CIs) were calculated for each outcome. In acute studies, intake of higher compared with lower-protein meals resulted in greater DIT (SMD: 0.45; 95% CI: 0.26, 0.65; P < 0.001) and TDEE (SMD: 0.52; 95% CI: 0.30, 0.73; P < 0.001). Notably, the subgroup analysis indicated that this effect on DIT was statistically significant for studies involving participants with normal weight but not overweight/obesity, although it is not clear if this finding was a true effect or because of study design characteristics. In chronic studies (ranging from 4 d to 1 y), intake of higher compared with lower-protein diets resulted in greater TDEE (SMD: 0.29; 95% CI: 0.10, 0.48; P = 0.003) and resting energy expenditure (SMD: 0.18; 95% CI: 0.01, 0.35; P = 0.039), but no differences in DIT (SMD: 0.10; 95% CI: -0.08, 0.28; P = 0.27). There was no evidence that different types of protein impacted energy metabolism. Higher protein meals/diets increase components of energy expenditure. This trial was registered at the International Prospective Register of Systematic Reviews (https://www.crd.york.ac.uk/prospero; PROSPERO 2023) as CRD42023389642., Competing Interests: Conflict of interest As employees of Midwest Biomedical Research, LLG, CGA, MLW, and KCM have received funding and/or consulting fees in the last 24 mo from 89bio, Inc., Acasti Pharma Inc., Beren Therapeutics, Bragg Live Products, Campbell’s, Cargill, Eli Lilly and Company, General Mills, Greenyn Biotechnology, Hass Avocado Board, Helaina Inc., Indiana University Foundation, Matinas BioPharma, Medifast, National Cattlemen’s Beef Association, National Dairy Council, Naturmega, New Amsterdam Pharma, NeuroEnergy VenturesPepsiCo, Pharmavite, and Seed. KK and BG-J are employees of General Mills and had a role in the conceptualization of the study, the analysis, and contributed to the decision to submit the manuscript for publication. The authors declare no additional conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Recombinant human lactoferrin (rhLF) is of commercial interest for immune support as a food ingredient. The objective was to evaluate the immunogenicity/alloimmunization potential of Helaina rhLF (effera™) from K. phaffii over a 28-day period compared to bovine LF (bLF). Study 1 was a randomized, double-blind, parallel arm, controlled trial where 66 healthy adults were randomly allocated to 1 of 3 groups: high-dose rhLF (3.4 g/d), low-dose rhLF (0.34 g/d), or bLF (3.4 g/d). Participants completed a 28-day supplementation period with follow-up visits on Days 28, 56, and 84. Study 2 was a 12-week observational study with no intervention that enrolled 24 healthy adults. In both studies, serum was obtained for analysis of anti-LF antibody levels as the primary endpoint. In Study 1, change from baseline to Day 56 in serum anti-bLF antibodies in the bLF group (least squares geometric mean and 95% confidence interval for the post/pre ratio: 3.01; 2.08, 4.35) was greater than the changes in serum anti-hLF antibodies in the low-dose rhLF (1.07; 0.77, 1.49; P < 0.001) and high-dose rhLF (1.02; 0.62, 1.70; P < 0.001) groups. The rhLF groups had similar changes to the observational study, indicating no change in anti-hLF antibodies and no evidence of alloimmunization following ingestion. Changes in safety outcomes were similar between groups and within normal ranges. These results show that under the conditions of the protocol, no increased anti-hLF antibodies or adverse events were identified following ingestion of effera™ as a food ingredient at an intake level up to 3.4 g/d in healthy adults (clinicaltrials.gov: NCT06012669)., Competing Interests: Declaration of Conflicting InterestThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Nathan Rudemiller received consulting or advisory fees from Helaina Inc. Carrie-Anne Malinczak, Ross Peterson, and Anthony Clark are employees of Helaina Inc. and receives equity or stocks in the company. As employees of Midwest Biomedical Research, Kevin Maki, Liana Guarneiri, Caryn Adams, and Meredith Wilcox receive grants and/or consulting fees from 89bio Inc., Beren Therapeutics P.B.C., Cargill Inc., General Mills Inc., Greenyn Biotechnology Co. Ltd., Hass Avocado Board, Helaina Inc., Indiana University Foundation, Matinas BioPharma Holdings Inc., National Cattleman’s Beef Association, National Dair Council, Naturmega, PepsiCo Inc., Pharmavite LLC, NewAmsterdam Pharma, Bragg Live Products, Campbell Soup Company, Eli Lilly and Company, Medifast Inc., NeuroEnergy Ventures, and Seed Inc.

This National Lipid Association (NLA) Expert Clinical Consensus provides an overview of the physiologic and clinical considerations regarding the role of apolipoprotein B (apoB) measurement to guide clinical care based on the available scientific evidence and expert opinion. ApoB represents the total concentration of atherogenic lipoprotein particles in the circulation and more accurately reflects the atherogenic burden of lipoproteins when compared to low-density lipoprotein cholesterol (LDL-C). ApoB is a validated clinical measurement that augments the information found in a standard lipoprotein lipid panel; therefore, there is clinical value in using apoB in conjunction with a standard lipoprotein lipid profile when assessing risk and managing lipid-lowering therapy (LLT). ApoB has been shown to be superior to LDL-C in risk assessment both before and during treatment with LLT. In individuals, there can be discordance between levels of LDL-C and apoB, as well as LDL-C and non-high-density lipoprotein cholesterol (non-HDL-C), despite high levels of population-wide correlation. When there is discordance between LDL-C and apoB, or LDL-C and non-HDL-C, atherosclerotic cardiovascular disease risk generally aligns better with apoB or non-HDL-C. Additionally, apoB can be used in tandem with standard lipoprotein lipid measurements to diagnose distinct lipoprotein phenotypes. ApoB testing can inform clinical prognosis and care, as well as enable family cascade screening, when an inherited lipoprotein syndrome is identified. The NLA and other organizations will continue to educate clinicians about the role of apoB measurement in improving clinical risk assessment and dyslipidemia management. An urgent need exists to improve access and reimbursement for apoB testing., (Copyright © 2024. Published by Elsevier Inc.)

Background: This joint expert review by the Obesity Medicine Association (OMA) and National Lipid Association (NLA) provides clinicians an overview of the pathophysiologic and clinical considerations regarding obesity, dyslipidemia, and cardiovascular disease (CVD) risk., Methods: This joint expert review is based upon scientific evidence, clinical perspectives of the authors, and peer review by the OMA and NLA leadership., Results: Among individuals with obesity, adipose tissue may store over 50% of the total body free cholesterol. Triglycerides may represent up to 99% of lipid species in adipose tissue. The potential for adipose tissue expansion accounts for the greatest weight variance among most individuals, with percent body fat ranging from less than 5% to over 60%. While population studies suggest a modest increase in blood low-density lipoprotein cholesterol (LDL-C) levels with excess adiposity, the adiposopathic dyslipidemia pattern most often described with an increase in adiposity includes elevated triglycerides, reduced high-density lipoprotein cholesterol (HDL-C), increased non-HDL-C, elevated apolipoprotein B, increased LDL particle concentration, and increased small, dense LDL particles., Conclusions: Obesity increases CVD risk, at least partially due to promotion of an adiposopathic, atherogenic lipid profile. Obesity also worsens other cardiometabolic risk factors. Among patients with obesity, interventions that reduce body weight and improve CVD outcomes are generally associated with improved lipid levels. Given the modest improvement in blood LDL-C with weight reduction in patients with overweight or obesity, early interventions to treat both excess adiposity and elevated atherogenic cholesterol (LDL-C and/or non-HDL-C) levels represent priorities in reducing the risk of CVD., (Copyright © 2024. Published by Elsevier Inc.)

There is an increasing body of evidence supporting a link between low intakes of ω-3 long-chain polyunsaturated fatty acids (LCPUFA) and numerous diseases and health conditions. However, few people are achieving the levels of fish/seafood or eicosapentaenoic acid and docosahexaenoic acid intake recommended in national and international guidelines. Knowledge of a person's ω-3 LCPUFA status will benefit the interpretation of research results and could be expected to lead to an increased effort to increase intake. Dietary intake survey methods are often used as a surrogate for measuring ω-3 PUFA tissue status and its impact on health and functional outcomes. However, because individuals vary widely in their ability to digest and absorb ω-3 PUFA, analytical testing of biological samples is desirable to accurately evaluate ω-3 PUFA status. Adipose tissue is the reference biospecimen for measuring tissue fatty acids, but less-invasive methods, such as measurements in whole blood or its components (e.g., plasma, serum, red blood cell membranes) or breast milk are often used. Numerous commercial laboratories provide fatty acid testing of blood and breast milk samples by different methods and present their results in a variety of reports such as a full fatty acid profile, ω-3 and ω-6 fatty acid profiles, fatty acid ratios, as well as the Omega-3 Index, the Holman Omega-3 Test, OmegaScore, and OmegaCheck, among others. This narrative review provides information about the different ways to measure ω-3 LCPUFA status (including both dietary assessments and selected commercially available analytical tests of blood and breast milk samples) and discusses evidence linking increased ω-3 LCPUFA intake or status to improved health, focusing on cardiovascular, neurological, pregnancy, and eye health, in support of recommendations to increase ω-3 LCPUFA intake and testing., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Cardiovascular disease (CVD) is the leading cause of mortality worldwide. Therapeutic agents, such as those that lower low-density lipoprotein cholesterol, have been a critical factor in mitigating CVD event risk and demonstrate the important role that drug discovery plays in reducing morbidity and mortality. However, rapidly rising development costs, diminishing returns, and an increasingly challenging regulatory environment have all contributed to a declining number of cardiovascular (CV) therapeutic agents entering the health care marketplace. For pharmaceutical companies, a traditional cardiovascular outcomes trial (CVOT) can be a major financial burden and impediment to CV agent development. They can take as long as a decade to conduct, delaying potential investment return while carrying risk of failure. For patients, lengthy CVOTs delay drug accessibility. Without cost-effective CVOTs, drug innovation may be compromised, with CV patients bearing the consequences. This paper reviews potential approaches for making CV drug development more cost-effective., Competing Interests: Dr Davidson is the Chief Executive Officer of NewAmsterdam Pharma and holds stock or stock options. Dr Hsieh is the Executive Director of Research and Development of NewAmsterdam Pharma and holds stock or stock options. Drs Ducjkub abd Naju are employees of Midwest Biomedical Research, which has received consulting fees and grant funding from NewAmsterdam Pharma, Acasti Pharma, Beren Therapeutics, Eli Lilly and Company, Indiana University and Foundation, Matinas BioPharma, NorthSea Therapeutics, and 89Bio., (© 2024 The Authors.)

Objective: There is substantial inter-individual variability in response to weight loss interventions and emerging evidence suggests that weight loss during the early weeks of an intervention may be predictive of longer-term weight loss. This secondary analysis of data from a commercial program therefore examined 1) the associations between early weight loss (i.e., week 4) with final visit weight loss and duration on the program, and 2) other predictors of lower weight loss at final visit., Methods: Client charts of adults with overweight or obesity ( N  = 748) were analyzed. Clients were stratified into categories of weight loss at the week 4 (< and ≥2%, 3% and 4%) and final visits (< and ≥5% and 10%). Multivariate logistic regression was used to assess predictors of <5% and <10% final visit weight loss., Results: The odds ratios for losing <5% or <10% of weight at the final visit were higher (49.0 (95% CI: 13.84, 173.63) and 20.1 (95% CI: 6.96, 58.06)) for clients who lost <2% or <3% compared to those who lost ≥2% or ≥3% at week 4. Other predictors of not losing a clinically relevant amount of weight included female sex, use of higher calorie meal plans and shorter time in the program, among others. Those who lost ≥2% at week 4 also had a significantly greater percent program completion (109.2 ± 75.2% vs. 82.3 ± 82.4, p  < 0.01) compared with those who did not meet the 2% threshold., Conclusions: Lower 4-week weight loss was identified as a strong predictor of not losing a clinically relevant amount of weight. These results may be useful for the early identification of individuals who can be targeted for additional counseling and support to aid in attaining weight loss goals., Competing Interests: CDC, JRK, and SSJ are employees of Medifast, Inc. JLU is a member of the Medifast Scientific Advisory Board and receives consulting fees associated with that appointment. Within the prior 24 months, KCM has received consulting fees from entities that provide products or services related to weight management, including Medifast, Eli Lilly, Pharmavite, General Mills, and 89Bio; he also has current research grant funding from the National Dairy Council, Hass Avocado Board, Greenyn, the Indiana University Foundation, Naturmega, Cargill, and National Cattlemen's Beef Association. MLW and LLG are employees of and MB is a contractor for Midwest Biomedical Research, which has received consulting fees from entities that provide products or services related to weight management, including Medifast, Eli Lilly, Pharmavite, General Mills, and 89Bio., (© 2023 Jason Pharmaceuticals, Inc and The Authors. Obesity Science & Practice published by World Obesity and The Obesity Society and John Wiley & Sons Ltd.)

Objective: This randomized, double-blind, crossover study evaluated the bioavailability of eicosapentaenoic and docosahexaenoic acids (EPA+DHA) in a phospholipid-enhanced fish oil (PEFO) product versus a krill oil (KO) product (337 versus 206 mg EPA+DHA/1 g capsule) in healthy adults (N = 24). The aim of this study was to assess the plasma levels of EPA, DHA, and EPA+DHA following a single capsule of PEFO versus KO products in healthy adult men and women., Methods: Participants consumed a single dose of the assigned product, and plasma was obtained at baseline and periodically for 24 h after dosing., Results: The geometric mean ratio (GMR; 90% confidence interval) of incremental areas under the curve over 24 h PEFO:KO was 319/385 = 0.83 (0.60, 1.15 nmol/L*h), indicating a similar average increment for EPA+DHA with PEFO compared with KO across the 24-h period. The baseline-adjusted maximum concentration of EPA+DHA was greater for PEFO than KO (GMR: 1.25; 90% CI, 1.03-1.51). Finally, the geometric mean for the time to maximum concentration for EPA+DHA was lower for PEFO versus KO (P < 0.05)., Conclusion: Absorption of EPA+DHA from the two products was similar, but the absorption profiles differed (higher and earlier peak for PEFO)., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: The goal of this article is to summarize recent guidance on diet and cardiovascular health., Recent Findings: Cardiovascular diseases are the leading cause of death in the USA, and diet significantly impacts cardiovascular disease risk. The focus of contemporary dietary recommendations has shifted from single nutrient replacements to dietary patterns such as the Mediterranean, healthy USA, Dietary Approaches to Stop Hypertension, and healthy plant-based patterns. Recommended dietary patterns emphasize whole grains, fruits, vegetables, nuts, seeds, legumes/pulses, seafood, lean meats, and fish/seafood. They also limit intakes of ultra-processed foods, processed meats, and alcohol, as well as foods high in salt and added sugars, particularly sugar-sweetened beverages., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Obesity is highly prevalent in the U.S. and is associated with an increased risk of major adverse cardiovascular events (MACE). Modalities for the management of obesity include lifestyle intervention, pharmacotherapy, and bariatric surgery., Areas Covered: This review describes the evidence on the effects of weight loss therapies on MACE risk. Lifestyle interventions and older antiobesity pharmacotherapies have been associated with <12% body weight reduction and no clear benefit to reduce MACE risk. Bariatric surgery is associated with substantial weight reduction (20-30%) and markedly lower subsequent risk for MACE. Newer antiobesity pharmacotherapies, particularly semaglutide and tirzepatide, have shown greater efficacy for weight reduction compared with older medications and are being evaluated in cardiovascular outcomes trials., Expert Opinion: Current practice for cardiovascular risk reduction in patients with obesity is lifestyle intervention for weight loss, combined with the treatment of obesity-related cardiometabolic risk factors individually. The use of medications to treat obesity is relatively rare. In part, this reflects concerns about long-term safety and weight loss effectiveness, possible provider bias, as well as lack of clear evidence of MACE risk reduction. If ongoing outcomes trials demonstrate the efficacy of newer agents in reducing MACE risk, this will likely lead to expanded use in obesity management.

Lifestyle habits can have a profound impact on atherosclerotic cardiovascular disease (ASCVD) risk. The National Lipid Association previously published recommendations for lifestyle therapies to manage dyslipidemia. This Clinical Perspective provides an update with a focus on nutrition interventions for the three most common dyslipidemias in adults: 1) low-density lipoprotein cholesterol (LDL-C) elevation; 2) triglyceride (TG) elevation, including severe hypertriglyceridemia with chylomicronemia; and 3) combined dyslipidemia, with elevations in both LDL-C and TG levels. Lowering LDL-C and non-high-density lipoprotein cholesterol are the primary objectives for reducing ASCVD risk. With severe TG elevation (≥500 mg/dL), the primary objective is to prevent pancreatitis and ASCVD risk reduction is secondary. Nutrition interventions that lower LDL-C levels include reducing cholesterol-raising fatty acids and dietary cholesterol, as well as increasing intakes of unsaturated fatty acids, plant proteins, viscous fibers, and reducing adiposity for patients with overweight or obesity. Selected dietary supplements may be employed as dietary adjuncts. Nutrition interventions for all patients with elevated TG levels include restricting intakes of alcohol, added sugars, and refined starches. Additional lifestyle factors that reduce TG levels are participating in daily physical activity and reducing adiposity in patients with overweight or obesity. For patients with severe hypertriglyceridemia, an individualized approach is essential. Nutrition interventions for addressing concurrent elevations in LDL-C and TG include a combination of the strategies described for lowering LDL-C and TG. A multidisciplinary approach is recommended to facilitate success in making and sustaining dietary changes and the assistance of a registered dietitian nutritionist is highly recommended., Competing Interests: Declaration of Competing Interest CFK is an employee of Midwest Biomedical Research and has no additional conflicts of interest to report beyond those disclosed for KCM. During the past 24 months, CAMA received honoraria for Science Advisory Board from Weight Watchers and McCormick Science. During the past 24 months, KEA  received honoraria for principal investigator for Amgen, Esperion, Novartis, and Ionis. During the past 24 months, PMKE received research grants for American Pecan Council, American Pistachio Growers, Hass Avocado Board, McCormick Science Institute, Ocean Spray Cranberries, NIH – Byambaa, NIH – Paul, NIH – Al-Shaar and served on Advisory Boards for HumanN, Seafood Nutrition Partnership, and Heali. During the past 24 months, KCM received research grants for 89Bio, Acasti Pharma, Beren Therapeutics, Bragg Live Products, Campbell’s, Cargill, Eli Lilly, General Mills, Greenyn Biotechnology, Hass Avocado Board, Indiana University Foundation, Medifast, National Cattlemen’s Beef Association, Matinas Biopharma, National Dairy Council, Naturmega, NeuroEnergy Ventures, New Amsterdam Pharma, Pepsico, Pharmavite, and Seed, Inc. GS, KSP, and JPB have nothing to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Background: Obicetrapib, a selective cholesteryl ester transfer protein (CETP) inhibitor, reduces low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), lipoprotein particles, and apolipoproteins, when added to high-intensity statin in patients with dyslipidemia., Objective: To evaluate the safety and lipid-altering efficacy of obicetrapib plus ezetimibe combination therapy as an adjunct to high-intensity statin therapy., Methods: This double-blind, randomized, phase 2 trial administered 10 mg obicetrapib plus 10 mg ezetimibe (n = 40), 10 mg obicetrapib (n = 39), or placebo (n = 40) for 12 weeks to patients with LDL-C >70 mg/dL and triglycerides (TG) <400 mg/dL, on stable high-intensity statin. Endpoints included concentrations of lipids, apolipoproteins, lipoprotein particles, and proprotein convertase subtilisin kexin type 9 (PCSK9), safety, and tolerability., Results: Ninety-seven patients were included in the primary analysis (mean age 62.6 years, 63.9% male, 84.5% white, average body mass index of 30.9 kg/m 2 ). LDL-C decreased from baseline to week 12 by 63.4%, 43.5%, and 6.35% in combination, monotherapy, and placebo groups, respectively (p<0.0001 vs. placebo). LDL-C levels of <100, <70, and <55 mg/dL were achieved by 100%, 93.5%, and 87.1%, respectively, of patients taking the combination. Both active treatments also significantly reduced concentrations of non-HDL-C, apolipoprotein B, and total and small LDL particles. Obicetrapib was well tolerated and no safety issues were identified., Conclusion: The combination of obicetrapib plus ezetimibe significantly lowered atherogenic lipid and lipoprotein parameters, and was safe and well tolerated when administered on top of high-intensity statin to patients with elevated LDL-C., (Copyright © 2023. Published by Elsevier Inc.)