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The primary objective of the study was to evaluate the effect of a hydrolyzed polysaccharide, Rice Bran Arabinoxylan Compound (RBAC), on biomarkers in adults with nonalcoholic fatty liver disease (NAFLD). A 90-day randomized double-blind placebo-controlled trial examined the effect of RBAC on complete blood count, liver enzymes, lipids, oxidative stress markers, cytokines, and growth factors. Twenty-three adults with NAFLD were enrolled and randomly assigned to one of the two study conditions (n = 12 RBAC and n = 11 placebo) and consumed 1 gram/day of either compound for 90 days. Subjects were assessed at baseline and 45 and 90 days. No adverse effects were reported. Alkaline phosphatase significantly decreased (−3.1%; SD = 19.9; F[1, 19] = 5.1, p=0.03) in the RBAC group compared to placebo. Percent monocytes (17.9%; SD = 18.3; F[1, 19] = 5.9, p=0.02) and percent eosinophils (30.6%; SD = 30.5; F[1, 19] = 12.3, p<0.01) increased in the RBAC group. IFN-γ (156%; SD = 131.8; F[1, 19] = 4.2, p=0.06) and IL-18 (29.1%; SD = 64; F[1, 19] = 5.3, p=0.03) increased in the RBAC group compared to placebo. Other improvements were noted for platelets, neutrophils, neutrophil-lymphocyte ratio, γ-glutamyl transferase, and 4-hydroxynonenal. RBAC had beneficial effects on several biomarkers that add to the known immunomodulatory activities of RBAC, which may be promising for people with NAFLD. This trial is registered with NCT02568787.

The risk of developing Type 2 Diabetes Mellitus in people living with HIV (PLWH) can be four times greater and can occur at an earlier age and even without the presence of obesity compared to those without HIV. Therefore, the purpose of this analytical cross-sectional study was to determine the relationship between HIV duration and glucose metabolism among PLWH. Eighty-two PLWH were categorized into shorter (≤15 years) or longer HIV duration (≥16 years) and then compared for differences in demographics, physical and clinical characteristics, biomarkers, and dietary intake. Compared to those with shorter HIV duration (n = 34), those with longer HIV duration (n = 48) were on average older (p = 0.02), reported lower consumption of alcohol (p = 0.05), had higher levels of homeostasis model assessment of insulin resistance (HOMA-IR, p = 0.02), were also more likely to be a woman (p = 0.06), and have higher levels of fasting insulin (p = 0.06). When adjusted for age and body weight, the levels of HOMA-IR and fasting insulin were higher (p = 0.02 and p = 0.04) with longer compared to shorter HIV duration, respectively. Longer exposure to HIV infection is associated with impaired insulin sensitivity. Continuing research aimed at the long-term effects of HIV infection and (antiretroviral therapy) is required.

Background. People living with HIV (PLWH) have increased risk of cardiovascular disease (CVD). The Framingham Risk Score (FRS) predicts a 10-year CVD risk. Its relationships to physical fitness and C-reactive protein (CRP) are not well established. The current aim is to determine the links between FRS, physical fitness, and CRP in PLWH. Methods. Participants (n = 87) were assessed on multiple biomarkers. The FRS was calculated with the respective variables. Other variables that correlated significantly with FRS were entered into a regression equation to determine their relationship to FRS. Results. The FRS for men was more than twice that for women (12.8 vs 6.0, P < .001). Men were more fit than women, but most participants were not fit. Aerobic capacity was predictive of FRS in men, but not in women, and muscular strength was not predictive of FRS. Women had more than double the CRP compared with men (7.9 vs 3.5 mg/L, P < .01), and it was unrelated to FRS. Conclusions. In men, aerobic capacity was significantly predictive of FRS, but muscular strength and CRP were unrelated to FRS in both genders. These results do not conclusively demonstrate that physical fitness and CRP are related to FRS in PLWH.

Background Magnesium (Mg) deficiency contributes to the pathophysiology of numerous diseases. The therapeutic use of Mg has steadily increased over time. The increased in-hospital use of intravenous (IV) magnesium sulfate (MgSO4) warrants more extensive investigation regarding the safety of the therapy. The aim of this study was to determine the safety of IV MgSO4 infusion on cardiovascular, liver, kidney, and metabolic markers in adults. Methods Twelve volunteers were randomized to one of two cross-over conditions: (a) IV infusion of MgSO4 in 5% dextrose followed by IV infusion of 5% dextrose 1 week later or (b) IV infusion of 5% dextrose followed by IV infusion of MgSO4 in 5% dextrose 1 week later. An electrocardiogram was recorded continuously during the infusions. Blood was drawn pre- and post-infusion for blood count (high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides). Results: Serum Mg increased from pre- to post-infusion in the MgSO4 + 5% dextrose group (p < 0.0001). The QRS interval length increased from pre- to post-infusion in the MgSO4 + 5% dextrose group (p < 0.04). Additionally, serum glucose concentration increased in the MgSO4 + 5% dextrose group (p = 0.04). These significant findings were modeled with gender and age as covariates. No other significant differences were found. Conclusions The administration of IV infusion of MgSO4 (4 g/100 mL) in 5% dextrose over a 4-hour treatment period poses no significant deleterious effects on cardiovascular, liver, kidney, or metabolic function. Relevance for patients IV infusion of MgSO4 may be used for certain treatment indications without significant concern for systemic or organ toxicity.

Vitamin D and its association with cardiovascular disease (CVD) are currently a topic of investigation. The objective of this study was to explore the association between vitamin D status (serum 25-hydroxyvitamin D (25(OH)D)) and a cardiometabolic risk score (CMRS) derived from markers of cardiac autonomic nervous system activity, vascular dynamics, and body composition, using an innovative non-invasive technology. We found that individuals who were vitamin D sufficient ((25(OH)D) ≥ 30 ng/ml, n = 51), compared to those who were vitamin D insufficient (

Background and Aim The objective of the present study was to investigate the relationships among pro-brain-derived neurotrophic factor (BDNF) and mature BDNF and immune functioning during aloe polymannose multinutrient complex (APMC) treatment in persons with moderate to severe Alzheimer's dementia (AD). Materials and Methods An open-label trial of 12 months was used to execute the study. Thirty-four adults with AD were enrolled and consumed four teaspoons/day of APMC for 12 months. Subjects were assessed at baseline and 12 months follow-up for proBDNF and BDNF and cytokines, growth factors, T-cell and B-cell subsets, and complete blood count to measure immune functioning. All biomarkers were intercorrelated. Results Several relationships were identified between proBDNF, BDNF, and BDNF/proBDNF ratio and immune function at 12 months, particularly BDNF with vascular endothelial growth factor (VEGF) (r=0.55, P=0.03), epidermal growth factor (EGF) (r=0.74, P=0.001), and CD95+CD3+ (%) (r=-0.64, P=0.03) and proBDNF with VEGF (r=0.64, P=0.02), EGF (r=0.86, P

Background Diabetes-associated microvascular complications such as retinopathy and neuropathy often lead to end-organ and tissue damage. Impaired skin microcirculation often precedes the detection of other advanced diabetic complications. The ANS-1 system contains a redesigned sympathetic skin response (ANS-1 SSR) device that measures sudomotor function, a photoplethysmography sensor, and a blood pressure device to comprehensively assess cardiac autonomic neuropathy and endothelial dysfunction. The purpose of this study was to determine the relationships between the ANS-1 SSR amplitude measured at the: (a) negative electrode (Nitric Oxide [NO] Sweat Peak) with microvascular diseases and associated vascular blood markers and (b) positive electrode (iSweat Peak) with C fiber function. Methods All participants (healthy controls n = 50 and retinopathy patients n = 50) completed the ANS-1 system evaluation and a basic sociodemographic and medical history questionnaire, including a quality of life measure (SF-36). A small sample of blood was drawn to determine levels of homocysteine, blood urea nitrogen (BUN), C-reactive protein (CRP), and fibrinogen. Symptoms of peripheral foot neuropathy were assessed with a scale from 1 (none) to 10 (the worst). We used Spearman rank correlations, independent samples t-tests, and receiver operating characteristic curves to determine the specificity and sensitivity of the NO Sweat Peak as a potential screening marker of retinopathy. Results The ANS-1 System Cardiometabolic Risk Score and all indicators of quality of life on the SF-36, other than Emotional Role Functioning, were significantly worse in the retinopathy patients. The sudomotor response marker NO Sweat Peak had a sensitivity of 88% and a specificity of 68% (Area Under the Curve = 0.81, p

Purpose: Chronic migraines and headaches are significant public health problems, and their symptomatologies have been positively linked to diet. We explored if individuals suffering from chronic migraines/ headaches who required medication treatment had improvement in symptomatology and subjective ratings of QoL when following an immune-reactive food exclusion diet based on the results of the ImmunoBloodprint test, an IgG-mediated food sensitivity assay. Methods: Thirty-seven subjects, aged 18 and over, took part in the study. Subjects had to eliminate all reactive foods from their diet for 90 days. Migraine intensity and frequency were measured using the MTAQ, and QoL was assessed with the SF-36 survey at base- line and 30-, 60-, and 90-day follow-up. Results: Sub- jects who eliminated IgG-mediated reactive foods from their diet had reductions in migraine symptomatology and had improvements in nearly all indicators of QoL, according to the SF-36, from baseline to 90-day follow-up. Conclusions: Subjects were able to improve their migraine symptoms and QoL in response to eliminating IgG reactive foods from the diet. This test may represent a strategy to help mediate chronic migraine symptomatology without the use of medication.

Purpose: Irritable bowel syndrome (IBS) and gastrointestinal (GI) disorders are genuine health problems that have serious consequences on a patient’s quality of life (QoL). IBS is a functional disorder characterized by chronically recurring symptoms, including abdominal pain or discomfort, altered stool frequency and consistency, and abdominal bloating in the absence of structural or biochemical abnormalities. Studies have indicated that symptoms and disability related to IBS and GI disorders correlate with QoL measures. Additionally, those who respond to therapy have an improvement in QoL. Therefore, we explored an open trial of a food elimination diet guided by the ImmunoBloodprint food sensitivity test and its effect on QoL in patients self-reporting an unresolved GI disorder. Methods: Eighty-four subjects aged 18 and above participated in the study. Subjects eliminated all IgG-mediated reactive foods from their diet for 90 days. QoL was assessed with the Irritable Bowel Syndrome-36 (IBS-36) and the Medical Outcomes Study Short Form-36 (SF-36) at baseline and 30-, 60-, and 90-day follow-up. The data were analyzed with linear mixed models. Results: Subjects had statistically significant improvements in all indicators of QoL according to the IBS-36 and SF-36 from baseline to 90- day follow-up. Conclusions: Subjects with unresolved self-reported GI disorders were able to improve all indicators of QoL in response to eliminating IgG- reactive foods from the diet. Given the inconvenience of keeping track of foods and symptoms to eliminate intolerant foods, a food sensitivity test combined with an elimination diet may be an effective method for improving subjective markers of QoL and health.

Alzheimer's disease (AD) is a leading killer of Americans, imparts a significant toll on the quality of life of the patient and primary caregiver, and results in inordinate costs in an already overburdened medical system. Prior studies on cholinesterase inhibitors among AD patients have shown minimal amelioration of disease symptoms and/or restoration of lost cognitive functioning. The effect of improved nutrition, particularly with dietary supplements, on cognitive functioning may offer an alternative strategy compared to standard treatment. The present pilot study investigated the effect of an aloe polymannose multinutrient complex (APMC) formula on cognitive and immune functioning over 12 months among adults diagnosed with AD. Subjects participated in an open-label trial and consumed 4 teaspoons per day of the APMC. The ADAS-cog, MMSE, ADCS-ADL, and SIB were administered at baseline and 3, 6, 9, and 12 months follow-up. Cytokines and lymphocyte and monocyte subsets were assessed at baseline and 12 months. The mean ADAS-cog cognition score significantly improved at 9 and 12 months from baseline, and 46% of our sample showed clinically-significant improvement (≥4-point change) from baseline to 12 months. Participants showed significant decreases in tumor necrosis factor-α, vascular endothelial growth factor, and interleukins-2 and-4. CD90+, CD95+CD3+, CD95+CD34+, CD95+CD90+, CD14+CD34+, CD14+CD90+, and CD14+CD95+ decreased significantly, whereas CD14+ significantly increased. Participants tolerated the APMC supplement with few, temporary adverse reactions. Our results showed improvements in both clinical and physiological outcomes for a disease that otherwise has no standard ameliorative remedy.

Background Declining cognitive function is relatively common and increasingly prevalent. Studies have shown that different nutrients (e.g., Ginkgo biloba and vitamin E) appear to be effective at improving memory and concentration, while less is known about their effect on immunity. Methods This study investigated the effect of Ginkgo Synergy® plus Choline (n = 33) and OPC Synergy® plus Catalyn® (n = 31) versus placebo (n = 33) in a 6-month, randomized, double-blind trial on cognitive and immune functioning among English-speaking, non-smoking, healthy older adults. The Stroop Color and Word Test, Trail Making Test A and B, Controlled Oral Word Association, Hopkins Verbal Learning, Mini-Mental State Exam, and Digit Symbol were administered at baseline and 3 and 6 months follow-up to assess cognitive functioning. Cytokines and growth factors were measured at baseline and 6 months to assess inflammation and immune functioning. Data were analyzed with linear mixed modeling. Results No serious adverse events were noted in this study. According to time on the Trail Making Test-B, the Ginkgo Synergy® plus Choline arm showed improvement from baseline to 3 months follow-up (mean difference = 24.2; SE = 6.4; 95% CI: 8.6, 39.7; p = 0.01). On the Controlled Oral Word Association Trial-S, the scores significantly increased for the Ginkgo Synergy® plus Choline arm from baseline to 6 months follow-up (mean difference = 2.1; SE = 0.8; 95% CI: 0.2, 3.9; p

John E Lewis1, Stacey L Tannenbaum1, Jinrun Gao3, Angelica B Melillo1, Evan G Long1, Yaima Alonso2, Janet Konefal1, Judi M Woolger2, Susanna Leonard1, Prabjot K Singh1, Lawrence Chen1, Eduard Tiozzo1 1Department of Psychiatry and Behavioral Sciences, 2Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, 3State Farm Insurance, Bloomington, IL, USA Background and purpose: The Electro Sensor Complex (ESC) is software that combines three devices using bioelectrical impedance, galvanic skin response, and spectrophotometry: (1) ES-BC (Electro Sensor-Body Composition; LD Technology, Miami, FL) to assess body composition, (2) EIS-GS (Electro Interstitial Scan-Galvanic Skin; LD Technology) to predict autonomic nervous system activity, and (3) ES Oxi (Electro Sensor Oxi; LD Technology) to assess cardiac output. The objective of this study was to compare each to a standardized assessment: ES-BC to dual-energy X-ray absorptiometry (DXA), EIS-GS to heart rate variability, and ES Oxi to BioZ Dx Diagnostic System (BioZ Dx; SonoSite Inc, Bothell, WA). Patients and methods: The study was conducted in two waves. Fifty subjects were assessed for body composition and autonomic nervous system activity. Fifty-one subjects were assessed for cardiac output. Results: We found adequate relative and absolute agreement between ES-BC and DXA for fat mass (r = 0.97, P < 0.001) with ES-BC overestimating fat mass by 0.1 kg and for body fat percentage (r = 0.92, P < 0.001) with overestimation of fat percentage by 0.4%. For autonomic nervous system activity, we found marginal relative agreement between EIS-GS and heart rate variability by using EIS-GS as the predictor in a linear regression equation (adjusted R2 = 0.56, P = 0.03). For cardiac output, adequate relative and absolute agreement was found between ES Oxi and BioZ Dx at baseline (r = 0.60, P < 0.001), after the first exercise stage (r = 0.79, P < 0.001), and after the second exercise stage (r = 0.86, P < 0.001). Absolute agreement was found at baseline and after both bouts of exercise; ES Oxi overestimated baseline and stage 1 exercise cardiac output by 0.3 L/minute and 0.1 L/minute, respectively, but exactly estimated stage 2 exercise cardiac output. Conclusion: ES-BC and ES Oxi accurately assessed body composition and cardiac output compared to standardized instruments, whereas EIS-GS showed marginal predictive ability for autonomic nervous system activity. The ESC software managing the three devices would be useful to help detect complications related to metabolic syndrome, diabetes, and cardiovascular disease and to noninvasively and rapidly manage treatment follow-up. Keywords: fat mass, autonomic nervous system activity, Electro Sensor Complex, dual-energy X-ray absorptiometry, heart rate variability, and bioimpedance cardiography

ContextAuricular acupuncture is widely used to treat cocaine addiction in the United States and Europe. However, evidence from controlled studies regarding this treatment's effectiveness has been inconsistent.ObjectiveTo investigate the effectiveness of auricular acupuncture as a treatment for cocaine addiction.DesignRandomized, controlled, single-blind clinical trial conducted from November 1996 to April 1999.SettingSix community-based clinics in the United States: 3 hospital-affiliated clinics and 3 methadone maintenance programs.PatientsSix hundred twenty cocaine-dependent adult patients (mean age, 38.8 years; 69.2% men); 412 used cocaine only and 208 used both opiates and cocaine and were receiving methadone maintenance.InterventionPatients were randomly assigned to receive auricular acupuncture (n = 222), a needle-insertion control condition (n = 203), or a relaxation control condition (n = 195). Treatments were offered 5 times weekly for 8 weeks. Concurrent drug counseling was also offered to patients in all conditions.Main Outcome MeasuresCocaine use during treatment and at the 3- and 6-month postrandomization follow-up based on urine toxicology screens; retention in treatment.ResultsIntent-to-treat analysis of urine samples showed a significant overall reduction in cocaine use (odds ratio, 1.40; 95% confidence interval, 1.11-1.74; P = .002) but no differences by treatment condition (P = .90 for acupuncture vs both control conditions). There were also no differences between the conditions in treatment retention (44%-46% for the full 8 weeks). Counseling sessions in all 3 conditions were poorly attended.ConclusionsWithin the clinical context of this study, acupuncture was not more effective than a needle insertion or relaxation control in reducing cocaine use. Our study does not support the use of acupuncture as a stand-alone treatment for cocaine addiction or in contexts in which patients receive only minimal concurrent psychosocial treatment. Research will be needed to examine acupuncture's contribution to addiction treatment when provided in an ancillary role.