Milk protein concentrate supplementation improved appetite, metabolic parameters, adipocytokines, and body composition in dieting women with obesity: a randomized controlled trial.

BACKGROUND: Dairy consumption is associated with many health benefits. However, to our knowledge, no clinical trials examined the effects of milk protein concentrate (MPC) on metabolic health in overweight and obese adults. This study investigated the effect of supplementation with MPC on glycaemic status, lipid profile, biomarkers of inflammation, and anthropometric measurements in women with obesity under a weight loss diet. METHODS: This is a single-blind, open-labelled, parallel-group, randomized trial. Forty-four healthy women with obesity were randomized into a control (n = 22) or MPC (n = 22) group. Participants in the MPC group were supplemented with 30 g of MPC per day for 8 weeks. Both groups were on a calorie-restricted diet plan with 800 Kcal lower intakes than their needs. Blood samples, dietary intake, and body composition were assessed before and after the intervention. RESULTS: MPC group had a significantly lower body mass index (P = 0.009), waist circumference (P = 0.013), fat mass (P = 0.021), appetite score (P = 0.002), fasting blood sugar (P < 0.001), insulin (P = 0.027), low-density lipoprotein cholesterol (P = 0.025), and leptin (P = 0.014) levels and higher high-density lipoprotein cholesterol (P = 0.001) and adiponectin (P = 0.032) compared to the control group after supplementation. Lean body mass, total cholesterol, and triglyceride did not differ significantly (P > 0.05). CONCLUSION: Daily intake of 30 g of MPC for 8 weeks may improve several anthropometric and metabolic markers in women with obesity under a hypocaloric diet.

Effects of milk protein concentrate supplementation on metabolic parameters, adipocytokines and body composition in obese women under weight-loss diet: study protocol for a randomised controlled trial.

INTRODUCTION: Obesity impairs metabolic function and increases the risk of cardiovascular disease and type 2 diabetes mellitus. Evidence suggests that high-protein diets help to increase weight loss and protect against weight gain. Milk protein concentrate (MPC) is a dairy product with a high protein content with a ratio of casein and whey protein similar to skim milk. This trial aims to evaluate the effect of MPC supplementation in obese women under a weight-loss diet. METHODS AND ANALYSIS: We will conduct a 2-month open-label, parallel-group, randomised controlled trial to determine the effect of MPC supplementation on levels of glycaemic and lipid profile, leptin, adiponectin, appetite, waist circumference, body mass index and body composition in 44 premenopausal obese women on a weight-loss diet. ETHICS AND DISSEMINATION: This protocol, approved by the Medical Ethics Committee of Ahvaz University of Medical Sciences, is in accordance with the Declaration of Helsinki (approval number: IR.AJUMS.REC.1399.795). The trial results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Iranian Registry of Clinical Trials (IRCT20201223049804N1).

The Effect of Nutrition Education Using MyPlate on Lipid Profiles, Glycemic Indices, and Inflammatory Markers in Diabetic Patients.

As a result of a nutrition transition, chronic diseases, including diabetes, have increased in Iran. Nutrition education is a cost-effective method for modifying diet and controlling diabetes. This study aimed to examine the effect of nutrition education using MyPlate recommendations on glycemic and lipid profiles and inflammatory markers in Iranian adults diagnosed with type 2 diabetes. A 12-week randomized clinical trial was conducted on 44 adults aged 30-50 years from Ahvaz, Iran. The participants were divided into education and control groups. The education participants were taught the MyPlate recommendations. Serum levels of fasting blood sugar (FBS), hemoglobin A1c (HbA1c), lipid profiles, and inflammatory markers, including high sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α, and adiponectin, were measured at the baseline and the end of the study. The results showed that serum levels of FBS (p = 0.014) and HbA1c (p < 0.001) decreased significantly in the education group at the end of the study. The serum level of low-density lipoprotein in the education group declined significantly at the end of the study (p = 0.043). Furthermore, the serum level of hs-CRP (p = 0.005) declined significantly while the level of adiponectin (p = 0.035) increased in the education group at the end of the study. The evidence of this study showed that nutrition education using MyPlate recommendations is an effective method for controlling diabetes complications. A longitudinal analysis with a larger sample size is recommended to confirm the evidence of this study. Trial Registration: Iranian Registry of Clinical Trials Identifier: IRCT2015031921443N2.

Association Between Dietary Quality Indices and Atherosclerosis Risk: A Case-Control Study.

Background: Several diet quality scores have been developed to evaluate the health benefits of individual diets such as Healthy Eating Index (HEI), Dietary Approach to Stop Hypertension (DASH), and Mediterranean diet score (Med). This study aims to determine the relationship between dominant dietary health scores with the risk of atherosclerosis in Iranian adults. Methods: This case-control study was conducted on 323 patients with atherosclerosis and 334 individuals without atherosclerosis as control group. Food Frequency Questionnaire was used for obtaining dietary intakes; then HEI, DASH score, and Med score was calculated. Logistic regression models were used to calculate Odds Ratios (OR) and 95% Confidence intervals (CI) between quartiles of the HEI, DASH and Med and atherosclerosis risk. Results: The results showed that total scores for HEI, DASH, and Med in control group was higher than the atherosclerosis group. The results also indicated that higher adherence to HEI (OR: 0.43; CI: [0.24, 0.76], P-trend = .006), DASH (OR: 0.48; CI: [0.3, 0.78], P-trend = .003), and Mediterranean pattern (OR: 0.4; CI: [0.21, 0.76]) decreased odds ratio of atherosclerosis. Conclusion: Our findings suggest that adherence to HEI, DASH, and Mediterranean diet might be associated with a lower risk of Atherosclerosis and can have a positive effect on general health and prevention of chronic diseases in people.

The effect of nigella sativa supplementation on cardiometabolic outcomes in patients with non-alcoholic fatty liver: A randomized double-blind, placebo-controlled trial.

BACKGROUND AND PURPOSE: Non-alcoholic fatty liver disease (NAFLD) is one of the metabolic disturbances associated with liver cell inflammation. Nigella sativa (N.sativa) is a widely used medicinal plant known for its anti-inflammatory, antimicrobial, antioxidant, and hepato-protective properties. This study aimed to assess the effect of supplementation of N. sativa oil on plasma levels of adiponectin, leptin, and blood pressure (BP) in patients diagnosed with NAFLD. MATERIALS AND METHODS: This randomized, double-blind, placebo-controlled clinical trial was conducted on 44 NAFLD patients. Participants were randomly assigned to two groups (n = 22/group); the experimental group received 1000 mg of N. sativa oil per day, while the control group received a placebo for eight weeks. The primary outcome measures were serum levels of adiponectin, leptin, and systolic and diastolic blood pressure measured at the baseline and the end of the intervention. RESULTS: After eight weeks of supplementation with N. sativa oil, no statistically significant differences were found in serum levels of adiponectin (p = 0.40), leptin (p = 0.89), systolic BP (p = 0.13), and diastolic BP (p = 0.09) between the two groups. Furthermore, after supplementation with N. sativa, no significant changes were observed in leptin (p = 0.07), adiponectin (p = 0.13), systolic BP (p = 0.82), and diastolic BP (p = 0.38) within the two groups. CONCLUSION: These results indicate that administration of N. sativa oil 1000 mg/day for 8 weeks has no favorable effect on cardiometabolic measures in NAFLD patients. Further studies with higher dosage over a longer period are needed to investigate whether this effect is dose- and time-dependent.

The synergic effects of alpha-lipoic acid supplementation and electrical isotonic contraction on anthropometric measurements and the serum levels of VEGF, NO, sirtuin-1, and PGC1-α in obese people undergoing a weight loss diet.

Background: The anti-obesity effects of Alpha-lipoic acid (α-LA) and isotonic contraction has been reported. However, the underlying mechanism is not fully understood. This study aimed to investigate the effect of 1200 mg/day α-LA supplementation and 3 sessions per week of Faradic (an electrical stimulating system) on anthropometric parameters, body composition, VEGF, Sirtuin-1, nitric oxide (NO), and PGC1-α in obese people undergoing a weight loss regime.Methods: This randomised clinical trial was carried out on 100 obese adults. The subjects were randomly assigned to four groups of 25 subjects including Faradic, α-LA, α-LA + Faradic, and control. A Bio Impedance Analyser (BIA) was used to estimate anthropometric measurements including weight, body mass index (BMI), fat mass, and fat free mass. The serum levels of Sirtuin-1, PGC1-α, VEGF, and NO levels were measured. All measurements were done at baseline and after 8 weeks of the intervention.Results: A significant weight reduction was observed in all four groups compared to baseline (p<.01). The placebo group had significantly higher weight, BMI, weight circumstance (WC), and body fat (BF) compared with the other groups. The α-LA + Faradic group had significantly lower weight, BMI, BF, WC than control, faradic, and α-LA groups and higher, Sirtuin and PGC than the control group (all p < .05).Conclusions: The findings indicated that the α-LA and Faradic interventions may have a synergistic effect on weight, BMI, BF, WC, and SLM, possibly through changes in serum level of VEGF, NO, and PGC. Further studies are warranted to clarify the mutual effects of -α-LA and Faradic on obesity and its molecular mechanisms. Name of the registry: Iranian Registry of Clinical TrialsTrial registration number: IRCT20131117015424N2Date of registration: 04/04/2018URL of trial registry record: https://www.irct.ir/search/result?query=IRCT20131117015424N2.

Testing the Effects of Cinnamon Extract Supplementation on Inflammation and Oxidative Stress Induced by Acrylamide.

We investigated the effects of cinnamon water extract supplementation on inflammation and oxidative stress induced by acrylamide in rats. This revealed acrylamide-intoxicated control group had significant higher levels of malondialdehyde, tumor necrosis factor-alpha (TNF-α), high-sensitive C-reactive protein (hs-CRP), leptin and alanine transaminase, and lower levels of total antioxidant capacity compared to the negative control group. In contrast, cinnamon extract administration remedied the levels of total antioxidant capacity, malondialdehyde, TNF-α, hs-CRP, and leptin in the treatment groups. However, there was no significant effect on adiponectin or liver enzymes. This chapter presents a protocol involving production of the acrylamide-induced oxidative stress model, the aqueous extraction of cinnamon powder, and measurement of inflammatory and oxidative stress markers.

The Effect of Pyridoxine Hydrochloride Supplementation on Leptin, Adiponectin, Glycemic Indices, and Anthropometric Indices in Obese and Overweight Women.

Obesity has reached epidemic proportions globally. Among several methods for treating obesity, the use of dietary supplements is common recently. One supplement that can help in this regard might be vitamin B6 in high doses. The objective of this study was to evaluate the effect of pyridoxine hydrochloride supplementation on anthropometric indices, body composition, visceral adiposity index (VAI), and metabolic status in obese and overweight women. In this randomized controlled clinical trial, 44 obese and overweight women aged 18-50 years were selected and divided randomly into 2 groups: an intervention group (receiving 80 mg pyridoxine hydrochloride supplement for 8 weeks) and a control group (receiving placebo for 8 weeks). In the pyridoxine hydrochloride group, weight (p = 0.03), body mass index (p = 0.023), fat mass (p = 0.003), waist circumference (p = 0.005), VAI (p = 0.001), fasting insulin, insulin resistance (homeostasis model assessment of insulin resistance; HOMA-IR), total cholesterol, low-density lipoprotein, triglycerides (TG) and leptin (p < 0.001) decreased whereas adiponectin (p < 0.001) increased in comparison to the baseline values. There was a significant difference in fat mass, VAI, fasting insulin, HOMA-IR, and TG between pyridoxine hydrochloride and control groups following intervention in adjusted models (p < 0.05). The findings suggest that vitamin B6 supplementation may be effective in reducing BMI and improving body composition and biochemical factors associated with obesity. TRIAL REGISTRATION: Iranian Registry of Clinical Trials Identifier: IRCT20181002041206N1.

The Effect of Synbiotic and Probiotic Supplementation on Mental Health Parameters in Patients Undergoing Hemodialysis: A Double-blind, Randomized, Placebo-controlled Trial.

INTRODUCTION: The purpose of this double-blind clinical trial, was to examine the effect of supplementation with the synbiotic and probiotic on the mental health, quality of life, and anemia in HD patients. METHODS: Seventy-five HD patients were randomly assigned to receive the synbiotic (n = 23) as 15 g of prebiotics, 5 g of probiotic powder containing Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis, and Bifidobacterium longum (2.7 × 107 CFU/g each); probiotics (n = 23) as 5 g probiotics similar to the synbiotic group with 15 g of maltodextrin as placebo; and placebo (n = 19) as 20 g of maltodextrin. Serum hemoglobin (Hb) and albumin (Alb) were measured. Beck depression and anxiety index (BDI/BAI) was used to assess symptoms of depression and anxiety. The health-related quality of life (HRQoL) was assessed using the questionnaire SF-36. RESULTS: From baseline to 12 weeks, synbiotic and probiotic supplementation resulted in a significant decrease in BDI and BAI score in comparison to the placebo (P < 0.05). Between and intergroup comparison showed no significant changes between the groups in terms of HRQoL. However, the serum Hb level increased significantly in the synbiotic and probiotic group compared to the placebo group (P < 0.001). CONCLUSION: Overall, 12 weeks of synbiotic and probiotic supplementation resulted in an improvement in mental health and anemia compared with the placebo, whereas they failed to enhance the quality of life in HD patients.

The antioxidant and anti-inflammatory effects of astaxanthin supplementation on the expression of miR-146a and miR-126 in patients with type 2 diabetes mellitus: A randomised, double-blind, placebo-controlled clinical trial.

BACKGROUND: The pathogenesis of type 2 diabetes mellitus (T2DM) is associated with chronic oxidative stress and inflammation. It is well known that the expression of some miRNAs such as miRNA-146a is upregulated in diabetic and hyperglycaemic patients, whereas circulating miRNA-126 is reduced. Therefore, we aimed to determine the effects of astaxanthin (AST) supplementation on the circulating malondialdehyde (MDA) and interleukin 6 (IL-6) levels, and the expression of miR-146a and miR-126 in patients with T2DM. METHODS: This randomised, double-blind, placebo-controlled clinical trial was conducted in 44 patients with T2DM randomly receiving 8 mg/d of oral AST (n = 22) or placebo (n = 22) for 8 weeks. RESULTS: We observed that AST supplementation could decrease plasma levels of MDA and IL-6 (P < .05) and decrease the expression level of miR-146a over time (fold change: -1/388) (P < .05). CONCLUSION: AST supplementation might be beneficial for improving circulating MDA and IL-6 and the down-regulation of miR-146a. However, future investigations are suggested to confirm these results.

Effect of synbiotic and probiotic supplementation on serum brain-derived neurotrophic factor level, depression and anxiety symptoms in hemodialysis patients: a randomized, double-blinded, clinical trial.

BACKGROUND: The aim of this study was to investigate the effects of probiotic and synbiotic supplementation on the depression and anxiety symptoms and serum brain-derived neurotrophic factor (BDNF) level. METHODS: Seventy-five HD patients were randomly assigned to receive the synbiotic (15 g of prebiotics, 5 g of probiotic containing Lactobacillus acidophilus T16, Bifidobacterium bifidum BIA-6, Bifidobacterium lactis BIA-7, and Bifidobacterium longum BIA-8 (2.7 × 107 CFU/g each)) or probiotics (5 g probiotics as in synbiotic group with 15 g of maltodextrin as placebo) or placebo (20 g of maltodextrin) for 12 weeks. Serum BDNF was measured by ELISA kit. Hospital Anxiety and Depression Scale (HADS) was used to assess symptoms of depression (HADS-DEP) and anxiety (HADS-ANX). RESULTS: From baseline to 12 weeks, synbiotic supplementation resulted in a significant decrease in HADS-DEP score in a subgroup of patients with depressive symptom (HADS-DEP ≥ 8) compared to the placebo and probiotic supplementation (p = .001, p = .002, respectively) and in all patients compared to the placebo (p = .004). There was no significant difference among the groups in terms of HADS-ANX scores. However, the HADS-ANX scores decreased significantly in the synbiotic group compared to the baseline in all patients (p = .047) and also patients with depressive symptom (p = .03). In addition, in a subgroup of HD patients with depressive symptom, the serum BDNF increased significantly in the synbiotic group when compared to the placebo (p < .001) and probiotic group (p = .011). CONCLUSION: Overall, 12 weeks of synbiotic supplementation resulted in greater improvement in depression symptoms and serum BDNF level compared to the probiotic supplementation in HD patients especially in the subgroup of patients with depression symptoms.

The effect of alpha-lipoic acid supplementation and electrical isotonic contraction on anthropometric parameters, body composition and angiogenesis factor, sirtunin-1 and peroxisome proliferator-activated receptor-γ coactivator-1α in obese people under a weight loss regime: A study protocol for a randomized controlled clinical trial.

BACKGROUND: Obesity is defined as a chronic disease, and is known as a public health problem in developed and developing countries. Several studies have shown the effects of anti-obesity of α-lactalbumin. AIM: This study was designed to investigate the effect of alpha-lipoic acid supplementation and electrical isotonic contraction on anthropometric parameters, body composition and angiogenesis factor, sirtunin-1 and peroxisome proliferator-activated receptor-γ coactivator-1α (PGC1α) in obese people under a weight loss regime. METHODS: Obese people who meet the inclusion criteria are included. Participants are randomly divided into four groups (alpha-lipoic (1200 mg) +weight loss regime group; Faradic (three 1 hour sessions) + weight loss regime group; alpha-lipoic (1200 mg) + Faradic (three 1 hour sessions) + weight loss regime group; control group (1200 mg placebo) for 2 months. At the beginning and the end of the study, demographic information, dietary intake, anthropometric parameters, body composition and serum levels of the angiogenesis factor (sirtunin-1, PGC1α and nitric oxide) are measured. CONCLUSION: Recent studies reported the anti-obesity effects of alpha-lipoic acid. This study is novel, since a similar study has not yet been carried out. This study evaluates the effect of 600 mg of alpha-lipoic acid supplementation or having three sessions of 1 hour per week electrical isotonic contraction induced by Faradic for 2 months alone or in combination in obese people that are undergoing a weight loss regime. TRIAL REGISTRATION: Iran Clinical Trials Registry, ID: IRCT20131117015424N2. Registered 2018-04-02.

Whey protein supplementation reducing fasting levels of anandamide and 2-AG without weight loss in pre-menopausal women with obesity on a weight-loss diet.

BACKGROUND: Despite the importance of dairy proteins in modifying of metabolic abnormalities, no attention has been given to their effects on endocannabinoids. METHODS: A total number of 60 obese women were recruited in a 2-month randomized clinical trial. Following random allocation, they were assigned to one of the two groups: control (n = 30) and intervention (n = 30). Then, all the subjects followed a hypocaloric diet of 800 kcal below estimated energy needs. The intervention group received isocaloric weight-loss diet and whey protein powders (30 g/day). Baseline and 2-month fasting anthropometric, blood glucose, serum insulin, insulin resistance, lipid profile, AEA, and 2-AG were measured. RESULTS: The study groups were homogenous in terms of baseline characteristics (p > 0.05) except for MUFA intake (p = 0.021). There were no significant differences in energy and macronutrient intakes in the intervention group compared to the control group at the end of the study (p > 0.05). The results of the ANCOVA did not show significant reductions in body weight and BMI of the intervention group compared to the control group (p > 0.05); however, WC, body fat, FBS, AEA, 2-AG, total cholesterol, and triglyceride decreased and HDL-c significantly increased in the intervention group compared to the control group (p < 0.05). CONCLUSIONS: In this study, the effects of simultaneous weight-loss diet and whey protein supplementation on the reduction of endocannabinoids were determined. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT2017021410181N8 . Registered on March 2017.

Cinnamon extract supplementation improves inflammation and oxidative stress induced by acrylamide: An experimental animal study.

OBJECTIVE: Toxic effects of acrylamide on body organs incline researches to prevent or decrease these effects. The objective of the present study was to evaluate the effects of cinnamon extract (CE) supplementation on inflammation and oxidative stress induced by acrylamide in rats. MATERIALS AND METHODS: Thirty two rats were divided into four groups as follow 1) The control group received distilled water, 2) Acrylamide- intoxicated group was administrated with 35 ml/kg/day acrylamide for two weeks, 3) Acrylamide- intoxicated rats treated with CE 250 mg/kg/day for 28 days, and 4) Acrylamide- intoxicated rats treated with CE 500 mg/kg day for 28 days. Fasting blood sample was obtained for subsequent analysis. RESULTS: The results showed that acrylamide- intoxicated group had significantly higher levels of malondialdehyde, tumor necrosis factor alpha, high sensitive C reactive protein, leptin and alanine transaminase (p<0.05 to p<0.01) and lower levels of total antioxidant capacity compared to the control group; whereas, cinnamon extract administration remedied levels of total antioxidant capacity, malondialdehyde, tumor necrosis factor alpha, high sensitive C reactive protein and leptin in the treatment groups, but it did not have a significant effect on adiponectin and liver enzymes (p>0.05). CONCLUSION: This study suggests that cinnamon extract may potentially be effective as a dietary source of bioactive compounds for managing acrylamide intoxication.

Effects of vitamin D3 supplementation for 12 weeks on serum levels of anabolic hormones, anaerobic power, and aerobic performance in active male subjects: A randomized, double-blind, placebo-controlled trial.

Maintenance of the serum 25-hydroxyvitamin D (25-OH-D) concentration at recommended levels is essential due to its role in the regulation of anabolic hormones and athletic performance. However, the results of the clinical experiments in athletes are controversial. The present study aimed to investigate the effect of vitamin D3 supplement on serum levels of anabolic hormones, cortisol, anaerobic and aerobic performance in active males. In this double-blind, randomized controlled trial, 46 active males randomly assigned to vitamin D3 supplement (VDS; 2000 IU/day) or placebo for 12 weeks. The Wingate test, VO2max, and serum levels of 25-OH-D, Parathyroid hormone (PTH), total testosterone, growth hormone (GH), Insulin-like growth factor-1 (IGF-1), and cortisol were assessed. Subjects in the VDS group had a higher serum level of 25-OH-D (p = 0.004), VO2max (p = 0.016), and average power (p = 0.044) compared to the placebo at the end of the study. Also, lower levels of PTH (p = 0.004) and fatigue index (p < 0.001) were observed in VDS group at the end of the study. The serum cortisol levels were reduced significantly only in subjects with vitamin D deficiency in VDS group (p = 0.042). There was a significant reduction in serum testosterone levels in VDS group (p = 0.013). No change was indicated in serum levels of GH and IGF-1 in VDS group compared to the placebo (p > 0.05). The present study showed an improvement in aerobic capacity, anaerobic performance, and vitamin D status following vitamin D3 supplementation. However, more studies are required for the effect of vitamin D3 on serum concentration of anabolic hormones.

Effects of Synbiotics and Probiotics Supplementation on Serum Levels of Endotoxin, Heat Shock Protein 70 Antibodies and Inflammatory Markers in Hemodialysis Patients: a Randomized Double-Blinded Controlled Trial.

The aim of this study was to investigate the effects of probiotic and synbiotic supplementation on serum inflammatory markers, endotoxin, and anti-HSP70 in hemodialysis (HD) patients. This study was a randomized, double-blind, placebo-controlled trial. Seventy-five hemodialysis patients who met the inclusion and exclusion criteria were randomly assigned for 12 weeks to one of the three arms: synbiotics [n = 23; 15 g of prebiotics, 5 g of probiotic powder containing Lactobacillus acidophilus T16, Bifidobacterium bifidum BIA-6, Bifidobacterium lactis BIA-6, and Bifidobacterium longum LAF-5 (2.7 × 107 CFU/g each)], probiotics [n = 23; 5 g probiotics as in synbiotic group with 15 g of maltodextrin in the sachet as placebo], and placebo [n = 19; 20 g of maltodextrin in the sachet]. Blood and feces were collected at baseline and after intervention. Serum high sensitive C-reactive protein (hs-CRP), interleukin-6, endotoxin, and anti-heat shock protein 70 antibodies (anti-HSP70) were measured. The number of fecal colonies was determined using the plate-counting method. The mean serum level of hs-CRP, anti-HSP70, and endotoxin decreased significantly between groups (p = 0.007, p = 0.037, and p = 0.036, respectively). For the synbiotic group, the mean changes in hs-CRP and IL-6 were significantly lower than for the placebo (p < 0.001 and p < 0.001, respectively) and probiotic group (p = 0.011 and p = 0.008, respectively). Anti-HSP70 mean changes in the synbiotic and probiotic groups differed from the placebo group (p = 0.002 and p = 0.013, respectively). Administration of synbiotics was more effective than probiotics for improvement of inflammatory markers, endotoxin and anti-HSP70 serum levels. Trial registration number: IRCT2017041233393N1.

The effect of Nigella sativa oil on serum levels of inflammatory markers, liver enzymes, lipid profile, insulin and fasting blood sugar in patients with non-alcoholic fatty liver.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is one of the metabolic disturbances associated with inflammation. Nigella sativa (NS) seed oil has different chemical compounds including Thymoquinone (TQ), unsaturated fatty acids, and flavonoids. NSs are used as anti-inflammatory and antioxidants in medical sciences. This study aimed to investigate the effect of NS oil on several parameters in serum levels of patients with NAFLD. METHODS: Forty-four patients diagnosed with NAFLD participated in a randomized, double-blind, placebo-controlled clinical trial. Patients were randomly assigned into two groups; one receiving NS oil and the other receiving placebo (paraffin oil), for 8 weeks. Blood samples were taken from the patients at the beginning and the end of the study. Afterwards, liver enzymes (ALT, AST, and GGT), inflammatory markers (Hs-CRP, TNF-α, and IL-6), insulin, lipid profiles (total cholesterol, triglyceride, VLDL, LDL-C, and HDL-C), FBS, and blood pressure were measured. RESULTS: Consumption of NS seed oil as supplement decreased the FBS level, lipid profiles (TG, TC, LDL, VLDL), liver enzymes (AST and ALT), hs-CRP inflammatory marker, IL-6, TNF-α, while it increased the HDL-C levels, compared to the placebo group (P < 0.05). Receiving NS oil had no significant effect on serum levels of insulin, blood pressure, and GGT in comparison with the beginning of the study (P < 0.05). CONCLUSION: NS seed oil supplements may decrease the liver enzymes and lipid profiles in the patients with NAFLD and play a protective role in the liver via reducing the inflammation in this group of patients.

Effect of Synbiotic and Probiotic Supplementation on Serum Levels of Endothelial Cell Adhesion Molecules in Hemodialysis Patients: a Randomized Control Study.

The aim of this study was to investigate the effect of synbiotic and probiotic supplementation on serum vascular dysfunction and necrosis markers in hemodialysis (HD) patients. In this randomized, double-blind, placebo-controlled trial, 75 HD patients were randomly assigned to either the synbiotic or probiotic or placebo group. The patients in the synbiotic group received 15 g of prebiotics and 5 g probiotic powder containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Bifidobacterium bifidum strain BIA-6, Bifidobacterium lactis strain BIA-6, Bifidobacterium longum strain LAF-5 (2.7 × 107 CFU/g each) in sachets (n = 25), whereas the probiotic group received 5 g probiotics same to the first group with 15 g of maltodextrin powder in sachets (n = 25) and the placebo group received 20 g of maltodextrin powder in sachets (n = 25) for 12 weeks. At baseline and the end of the study, serum concentrations of soluble intercellular adhesion molecule type 1 (sICAM-1), soluble vascular cell adhesion molecule type 1 (sVCAM-1), cytokeratin 18 (CK-18) as the necrosis marker, uric acid, and phosphate levels were measured. Feces also were collected for microbiota colony counting. Serum ICAM-1 level reduced significantly in the synbiotic group after the intervention period (P = 0.02), and this reduction was significantly different in the synbiotic group in comparison to the placebo group (P = 0.03). Serum levels of VCAM-1 and CK-18 were not significantly different between the groups. However, the reduction in serum levels of VCAM-1 in the synbiotic group was significantly higher in comparison to the placebo group (P = 0.01). Multivariate linear regression analysis revealed that ∆ phosphate was the sole independent determinant of ∆ICAM-1 (P = 0 < 001). The study indicated that synbiotic supplementation reduced serum ICAM-1 level, which is a risk factor for cardiovascular diseases in HD patients, but has no effect on the necrosis marker. Trial registration: www.irct.ir (IRCT2017041233393N1).

Astaxanthin improves glucose metabolism and reduces blood pressure in patients with type 2 diabetes mellitus.

BACKGROUND AND OBJECTIVES: This randomized, placebo-controlled trial was performed for 8 weeks to investigate the potential effects of astaxanthin (AST) supplementation on the adiponectin concentration, lipid peroxidation, glycemic control, insulin sensitivity, and anthropometric indices in participants with type 2 diabetes mellitus. METHODS AND STUDY DESIGN: We enrolled 44 participants with type 2 diabetes who met our inclusion criteria. Eight milligrams of AST supplementation or a placebo were randomly administered once daily for 8 weeks to these participants. RESULTS: The 8-week administration of AST supplementation increased the serum adiponectin concentration and reduced visceral body fat mass (p<0.01), serum triglyceride and very-low-density lipoprotein cholesterol concentrations, and systolic blood pressure (p<0.05). Furthermore, AST significantly reduced the fructosamine concentration (p<0.05) and marginally reduced the plasma glucose concentration (p=0.057). CONCLUSIONS: We demonstrated that because participants with type 2 diabetes often have hypertriglycemia and uncontrolled glucose metabolism; our findings of dual beneficial effects are clinically valuable. Our results may provide a novel complementary treatment with potential impacts on diabetic complications without adverse effects.

Effect of whey protein supplementation on levels of endocannabinoids and some of metabolic risk factors in obese women on a weight-loss diet: a study protocol for a randomized controlled trial.

BACKGROUND: Besides the effects of dietary long chain PUFA on circulating endocannabinoids concentrations, the impact of other nutrients on these system is not known and, whether changes in plasma endocannabinoids levels correlated with changes in body composition and biochemical metabolic risk factors in obese individuals, however, still remains to be characterized. METHODS: We will conduct a 2 months' open label, parallel-group, randomized controlled trial to determine the effect of whey protein supplementation on levels of endocannabinoids, glycemic and lipid profile, inflammatory factors, adipocytokines and body composition in 60 premenopausal obese women on a weight-loss diet. CONCLUSION: Due to strong relationship between endocannabinoids level and insulin resistance and obesity, in this trial, we will illustrate the other benefits of weight loss diet on health and metabolic risk factors. Also for the first, the effects of simultaneous weight loss diet and whey protein supplementation on these variables will be determined. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT2017021410181N8 .