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).

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.

Effect of lipoic acid supplementation on gene expression and activity of glutathione S-transferase enzyme in infertile men.

Oxidative stress has become the focus of interest as a potential cause of male infertility. We evaluate effects of lipoic acid (LA) supplementation on glutathione S-transferase (GST) expression. This randomized, triple-blind, placebo-controlled clinical trial was conducted on 44 infertile males with idiopathic asthenozoospermia. Men were randomized to receive 600 mg LA or placebo once daily for 12 weeks and semen samples and venous blood samples were obtained. GST expression, reactive oxygen species (ROS) levels, GST activity and reproductive hormone profiles were also measured. GST expression in the intervention group were significantly higher than the control group. Also, at the end of the study, GST activity increased, and ROS levels decreased significantly compared to the baseline. Additionally, the intervention group showed an increase in testosterone and decrease in serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and prolactin after 12 weeks, but this difference was not significant. We conclude a 12-week treatment with LA leads to improvements in reproductive hormones in serum, and significantly reduces the generation of ROS and increases the gene expression and activity of GST in seminal fluid.

Effect of weight-loss diet combined with taurine supplementation on body composition and some biochemical markers in obese women: a randomized clinical trial.

Taurine (Tau), an endogenous non-protein and sulfuric-amino acid, is involved in various biological pathways including anti-inflammatory, anti-oxidation, insulin resistance inhibition, and lipid profile improvement. According to some experimental and clinical studies, insulin resistance and excess body weight are associated with reduced serum level of Tau. Therefore, this study was aimed to evaluate Tau supplementation and a diet-induced weight-loss intervention on body composition and some biochemical indices of obese women. Participants were divided randomly into the intervention (standard weight-loss group + cap Tau 3 g/day for 8 weeks, n = 20) and control (standard weight-loss group + cap placebo for 8 weeks, n = 18) groups. To achieve weight loss, all participants received an individualized diet that included a 30% reduction in their total energy intake. Chi-square test was applied to compare categorical variables between two groups at baseline. Paired t test and independent-sample t test were also used to analyze the parametric continuous data within and between the two groups, respectively. Analysis of covariance was run for controlling the confounding variables. At the post-intervention, the mean changes of total cholesterol (p = 0.03), low-density lipoprotein cholesterol (p = 0.03), leptin (p = 0. 006), total adiponectin (p = 0.04), and high sensitivity C-reactive protein (p = 0.03) decreased significantly in Tau group compared with the control group. No significant results were found in the mean changes of high-density lipoprotein cholesterol, anthropometric measurements, glycemic indices, and liver enzymes between the two groups (p > 0.05). The findings showed that Tau supplementation along with a weight-loss diet may be more effective in improving the lipid profile and metabolic risk factors compared with a weight-loss diet alone.

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.

The effects of Anethum graveolens (dill) powder supplementation on clinical and metabolic status in patients with type 2 diabetes.

BACKGROUND: The objective of this study was to investigate the effects of Anethum graveolens (dill) powder supplementation on glycemic control, lipid profile, some antioxidants and inflammatory markers, and gastrointestinal symptoms in patients with type 2 diabetes. MATERIALS AND METHODS: In this study, 42 patients with type 2 diabetes were randomly allocated to intervention and control groups and received either 3 g/day dill powder or placebo (3 capsules/day, 1 g each). Fasting blood sugar, insulin, homeostatic model assessment of insulin resistance, lipid profile, high-sensitivity C-reactive protein, total antioxidant capacity, malondialdehyde and gastrointestinal symptoms were measured in all of the subjects at baseline and postintervention. RESULTS: The dill powder supplementation significantly decreased the mean serum levels of insulin, homeostatic model assessment of insulin resistance, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde in the intervention group in comparison with the baseline measurements (P < 0.05). Furthermore, the mean serum levels of high-density lipoprotein and total antioxidant capacity were significantly increased in the intervention group in comparison with the baseline measurement (P < 0.05). Colonic motility disorder was the only gastrointestinal symptom whose frequency was significantly reduced by supplementation (P = 0.01). The mean changes in insulin, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde were significantly lower in the intervention group than in the control group (P < 0.05). In addition, the mean changes in high-density lipoprotein were significantly higher in the intervention group than in the control group (P < 0.05). CONCLUSION: Dill powder supplementation can be effective in controlling the glycemic, lipid, stress oxidative and gastrointestinal symptoms in patients with type 2 diabetes. TRIAL REGISTRATION: Iran Clinical Trials Registry: IRCT20120704010181N12. Registered on 12 May 2018.

Effects of Vitamin D and Omega-3 Fatty Acids Co-Supplementation on Inflammatory Factors and Tumor Marker CEA in Colorectal Cancer Patients Undergoing Chemotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Objectives: This study aimed to investigate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory factors and tumor marker CEA in colorectal cancer patients undergoing chemotherapy.Methods: In this study, 81 patients with stage ӀӀ or ӀӀӀ colorectal cancer were randomly assigned into four groups: (1) control: receiving a vitamin D placebo, weekly + two omega-3 fatty acid placebo capsules, daily; (2) omega-3 fatty acid, receiving two omega-3 fatty acid capsules (each capsule containing 330 mg of omega-3 fatty acids), daily + a vitamin D placebo, weekly; (3) vitamin D, receiving a 50,000 IU vitamin D soft gel, weekly + two omega-3 fatty acid placebo capsules, daily; (4) co-supplementation, receiving a 50,000 IU vitamin D soft gel, weekly + two omega-3 fatty acids capsules, for 8 weeks. Before and after the intervention, serum levels of 25(OH)D, TNF-α, IL-1ß, IL-6, IL-8, NF-kB activity, and tumor marker CEA, were measured.Results: After 8 weeks of intervention, patients who received combined vitamin D and omega-3 fatty acids supplements compared with omega-3, vitamin D, and placebo had significantly decreased TNF-α, and IL-1ß (P < .05). In addition, serum levels of TNF-α, IL-1ß, IL-6, IL-8, and tumor marker CEA were decreased significantly in omega-3, vitamin D, and co-supplementation of them, compared with baseline. NF-kB activity was decreased significantly in vitamin D and co-supplementation groups, compared with baseline. Regarding CEA, there was no significant difference between the four groups at the end of intervention (P > .05).Conclusion: Results show that co-supplementation of vitamin D and omega-3 fatty acids co-supplementation, in colorectal cancer patients have beneficial impacts on inflammation and tumor marker CEA.

Ginger in patients with active ulcerative colitis: a study protocol for a randomized controlled trial.

BACKGROUND: As a lifetime disorder, ulcerative colitis (UC) is an inflammatory bowel disease (IBD) that affects quality of life and also demands long-term interventions. In spite of considerable side effects and sometimes restricted uses, efficient medications are available for UC treatment. Some in vitro and in vivo examinations have correspondingly introduced ginger and its active components with antioxidant, anti-inflammatory, and anti-ulcerative properties. Therefore, this trial aims to evaluate the effect of ginger supplementation on patients with active UC. METHODS: This study will be a 12-week, double-blind, parallel-group, randomized, controlled trial (RCT) in which 44 patients will be allocated to ginger and placebo groups receiving basic routine treatments plus ginger or placebo capsules, respectively. The primary outcomes are inflammatory markers (TNF-α and hs-CRP) and total antioxidant capacity. DISCUSSION: The findings of this trial will provide evidence on the effect of ginger on patients with active UC. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20190129042552N1. Registered on 21 June 2019.

Randomized Study Design to Test Effects of Vitamin D and Omega-3 Fatty Acid Supplementation as Adjuvant Therapy in Colorectal Cancer Patients.

This study examines the effects of vitamin D and omega-3 fatty acid co-supplementation on inflammation and nutritional status in colorectal cancer patients. Patients were randomly assigned into four groups: (1) controls, receiving placebos; (2) omega-3 fatty acid arm, receiving two 330 mg omega-3 fatty acid capsules daily and placebo (for vitamin D3) weekly; (3) vitamin D arm, receiving a 50,000 IU vitamin D3 soft gel weekly and two placebos (for omega-3 fatty acids) daily; and (4) co-supplementation arm, receiving a 50,000 IU vitamin D3 soft gel weekly and two 330 mg omega-3 fatty acids capsules daily for 8 weeks. As outcomes, we measure height; weight; fat-free mass (FFM); serum levels of 25(OH)D, TNF-α, and IL-6; C-CRP; and albumin, before and after the intervention. The presented results show that vitamin D3 plus omega-3 fatty acid co-supplementation in colorectal cancer patients has beneficial impacts on inflammation and nutritional status.

The effects of flaxseed supplementation on metabolic status in women with polycystic ovary syndrome: a randomized open-labeled controlled clinical trial.

BACKGROUND: Polycystic Ovary Syndrome (PCOS) is known as the most common endocrine disorder of women in reproductive ages. With the increasing prevalence of PCOS in different countries, the use of herbal medicine as an alternative treatment is growing in these patients. This study aimed to evaluate the effects of flaxseed powder supplementation on metabolic biomarkers of patients with PCOS. METHODS: This randomized open-labeled controlled clinical trial was conducted on 41 patients with PCOS. The participants were randomized to take either flaxseed powder (30 g/day) plus lifestyle modification or only lifestyle modification for 12 weeks. Anthropometric and biochemical evaluations were performed for all patients at the beginning and end of the study. RESULTS: The flaxseed group showed a significant reduction in body weight, insulin concentration, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), Triglycerides (TG), high-sensitivity C-Reactive Protein (hs-CRP), and leptin and an increase in Quantitative Insulin-Sensitivity Check Index (QUICKI), High Density Lipoprotein (HDL), and adiponectin compared to the baseline (p < 0.05). Flaxseed supplementation also led to a significant reduction in insulin concentration, HOMA-IR, TG, hs-CRP, Interleukin 6 (IL- 6), and leptin and an increase in QUICKI, HDL, and adiponectin compared to the control group (p < 0.05). No significant changes were observed in other parameters. CONCLUSIONS: Flaxseed supplementation plus lifestyle modification was more effective compared to lifestyle modification alone in biochemical and anthropometric variables in patients with PCOS. TRIAL REGISTRATION: The trial protocol was approved by the Ethics Board at Ahvaz Jundishapur University of Medical Sciences and was registered at Iranian Registry of Clinical Trials (code: IRCT20120704010181N11).

An energy-restricted high-protein diet supplemented with ß-cryptoxanthin alleviated oxidative stress and inflammation in nonalcoholic fatty liver disease: a randomized controlled trial.

The efficacy of ß-cryptoxanthin (BCX), a high-protein diet (HPD), or both in reducing oxidative stress and inflammation in nonalcoholic fatty liver disease (NAFLD) has never been examined within a randomized controlled trial (RCT). Thus, we aimed to assess the efficacy of an energy-restricted HPD supplemented with BCX in alleviating these conditions in NAFLD in an RCT design. We hypothesized that this combination may improve oxidative stress and inflammation in NAFLD as compared to a standard energy-restricted diet. Ninety-two ultrasonographically confirmed overweight/obese adult NAFLD patients attending an outpatient clinic in Ahvaz, Iran, were recruited for this 12-week, single-center, parallel-group, double-blind RCT from 2017 to 2018. Subjects were randomized into 4 equal groups (n = 23): HPD-BCX (energy-restricted HPD + BCX), HPD (energy-restricted HPD + placebo), BCX (standard energy-restricted diet + BCX), and control (standard energy-restricted diet + placebo). Serum levels of oxidative stress- and inflammation-related markers, as primary outcome measures, were determined at baseline and at the study end point. The 1-way analysis of covariance models in the intention-to-treat population (N = 92) showed that the HPD-BCX group achieved greater 12-week reductions in malondialdehyde, high-sensitivity C-reactive protein, interleukin-6, and total cytokeratin-18 (CK18-M65) but higher increases in total antioxidant capacity and adiponectin compared to the control group (mean differences for malondialdehyde, high-sensitivity C-reactive protein, interleukin-6, total cytokeratin-18, total antioxidant capacity, and adiponectin were -1.9 nmol/mL, -1.0 mg/L, -2.0 ng/L, -270.9 ng/L, 2.5 U/mL, and 1.9 mg/L, respectively; all P < .001). These results show that an energy-restricted HPD supplemented with BCX more efficaciously alleviates oxidative stress and inflammation in NAFLD as compared to a standard energy-restricted diet.

Randomized Study of the Effect of Vitamin D and Omega-3 Fatty Acids Cosupplementation as Adjuvant Chemotherapy on Inflammation and Nutritional Status in Colorectal Cancer Patients.

This study aimed to evaluate the effects of vitamin D3 and omega-3 fatty acids cosupplementation on inflammation and nutritional status in colorectal cancer patients. In this clinical trial, 81 colorectal cancer patients were randomly assigned into four groups: (1) control group: receiving a vitamin D3 placebo weekly + omega-3 fatty acid placebo capsules daily; (2) omega-3 fatty acid group: receiving 2 omega-3 fatty acid capsules (each capsule containing 330 mg of omega-3 fatty acids) daily + a vitamin D3 placebo weekly; (3) vitamin D group: receiving a 50,000 IU vitamin D3 soft gel weekly + 2 omega-3 fatty acid placebo capsules daily; (4) cosupplementation group: receiving a 50,000 IU vitamin D3 soft gel weekly + 2 omega-3 fatty acids capsules daily for 8 weeks. Before and after the intervention, height, weight, fat-free mass (FFM), serum levels of 25(OH)D, tumor necrosis factor alpha (TNF-α), and interleukin 6 (IL-6), C-reactive protein (CRP), and albumin, were measured. After 8 weeks of intervention, patients who received combined vitamin D3 and omega-3 fatty acids supplements compared with omega-3, vitamin D3, and placebo groups had significantly decreased CRP and TNF-α. In addition, serum level of IL-6 was decreased significantly in omega-3, vitamin D3, and cosupplementation groups compared with baseline. Regarding nutritional status, weight, BMI, and FFM% were increased significantly in vitamin D3, omega-3, and cosupplementation groups at the end of the intervention. Vitamin D3 plus omega-3 fatty acids cosupplementation in colorectal cancer patients has beneficial impacts on inflammation and nutritional status.

Effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in patients with colorectal cancer: a study protocol for a double blind randomized controlled trial.

BACKGROUND: Much evidence is available demonstrating that both vitamin D and omega-3 fatty acids block the development and progression of colonic carcinogenesis. The results of animal studies have shown that the consumption of omega-3 fatty acids can decrease inflammatory biomarkers, enhance the efficacy of chemotherapy, and decrease the side effects of chemotherapy or cancer. Also, observational studies propose that higher levels of 25(OH)D are related to improved survival of colorectal cancer patients. This study will aim to evaluate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in colorectal cancer patients. METHODS/DESIGN: We will carry out an 8-week double-blind randomized, placebo-controlled clinical trial to evaluate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in patients with stage ӀӀ or ӀӀӀ colorectal cancer undergoing chemotherapy. DISCUSSION: Because of the important effects of vitamin D and omega-3 fatty acids on molecular pathways involved in cancer development and progression, it seems that both vitamin D and omega-3 fatty acids may provide a new adjuvant therapy by decreasing inflammatory biomarkers and resistance to cancer treatment in patients with colorectal cancer. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20180306038979N1. Registered on 16 March 2018.

Evaluation of the effect of oral taurine supplementation on fasting levels of fibroblast growth factors, ß-Klotho co-receptor, some biochemical indices and body composition in obese women on a weight-loss diet: a study protocol for a double-blind, randomized controlled trial.

BACKGROUND: Taurine (Tau) is involved in many biochemical functions such as regulation of glucose and lipid metabolism, enhancement of energy expenditure, anti-inflammatory effects and appetite control. The most important effect of Tau in obesity is its direct effect on adipose tissue. Some evidence has shown an impaired FGF (fibroblast growth factor) 19 and 21 biosyntheses in obesity. Besides the effects of eicosapentaenoic acid on serum FGF concentrations, the effect of other nutrients on FGFs is not clear. Since obesity as an important health problem is rising around the world and on the other side, Tau biosynthesis is reduced by adipose-tissue-derived factors in obesity, the effects of Tau and a weight-loss diet on obesity need to be investigated further. METHODS: We will conduct an 8-week. double-blind, parallel-group, randomized controlled clinical trial to investigate the effect of Tau supplementation on fasting serum levels of FGFs, ß-Klotho co-receptor, some biochemical indices and body composition in 50 obese women aged between 18 and 49 years on a weight-loss diet. DISCUSSION: We will determine the other advantages of a weight-loss diet on new metabolic risk factors. Since Tau may regulate adipose-tissue-derived factors and a weight-loss diet can promote the useful effects of Tau supplementation; for the first time, the effects of a weight-loss diet along with Tau supplementation on these variables will be assessed. TRIAL REGISTRATION: Iran Clinical Trials Registry, ID: IRCT20131125015542N2 . Registered on 24 November 2018.

The Effects of UVB and Vitamin D on Decreasing Risk of Colorectal Cancer Incidence and Mortality: A Review of the Epidemiology, Clinical Trials, and Mechanisms.

The solar ultraviolet B-vitamin D-cancer hypothesis was first suggested in 1980 based on a geographical ecological study. Since then, several ecological and observational studies, as well as researches of mechanisms have supported the hypothesis. Also, the association between vitamin D condition and cancer risk has been assessed in a number of epidemiologic studies, while data from interventional studies remain scant. In regard of cancer locations, the body of evidence is most substantial for colorectal cancer, for which support comes from studies of 25(OH)D, vitamin D intake, and region of residence in a sunny weather. Collectively evidence demonstrates that vitamin D has a potent and beneficial effect at antagonizing and blocking several mitogenic mechanisms related to tumorigenesis. Taken together with the epidemiological studies and limited clinical trials, individuals may need to consider elevating 25(OH)D levels via sun exposure and/or vitamin D supplementation to decrease risk of colorectal cancer, in addition to standard care, treat cancer.

Effect of a high-protein diet with ß-cryptoxanthin supplementation on metabolic risk factors, oxidative and inflammatory biomarkers in non-alcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled clinical trial.

BACKGROUND: Excessive hepatic fat is associated with increased metabolic risk factors, production of inflammatory factors, and oxidative stress. High protein intake might trigger an increased hepatic lipid oxidation through an increase in hepatic energy expenditure. Furthermore, the majority of randomized controlled trials (RCT) in humans have failed to show whether carotenoids can be used to prevent and treat non-alcoholic fatty liver disease (NAFLD). However, it is notable and contradictory that NAFLD is rapidly escalating in Iran and other countries with lower intakes of fruit and vegetables (as sources of ß-cryptoxanthin [ß-CX] and carbohydrates) and higher intake of carbohydrates (as an agent of NAFLD); and the effects of ß-CX and a high protein diet (HPD) on NAFLD need to be investigated further. METHODS/DESIGN: This study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for 12 weeks to receive daily ß-CX 6 mg supplementation combined with a HPD on levels of metabolic factors, ß-CX, glycemic and lipid profiles, inflammatory factors, adipocytokines, and body composition. Ninety-two eligible patients, aged 18-60 years, of both genders, who are obese and overweight (body mass index [BMI] 25-40 kg/m2) will be randomly assigned to four groups as follow: HPD + placebo; normal protein diet + ß-CX (NPD + ß-CX); HPD + ß-CX; and NPD + placebo (control group). Two populations will be analyzed in this work. The intention-to-treat (ITT) population includes all patients who will be randomized, while the per-protocol (PP) population includes all individuals who complete the 12- week intervention (i.e. study completers). DISCUSSION: Our findings from this trial will contribute to the knowledge of the relationship between ß-CX supplementation and a HPD on NAFLD patients and determination of optimal macronutrient ratios without energy restriction. TRIAL REGISTRATION: Iran clinical trials registry, IRCT2017060210181N10 . Registered on 20 June 2017.

Effect of chlorella supplementation on systematic symptoms and serum levels of prostaglandins, inflammatory and oxidative markers in women with primary dysmenorrhea.

OBJECTIVE: Primary dysmenorrhea is one of the most commonly reported disorders for women that have unfavorable effects on patient's quality of life. Based on the evidences that suggest the anti-inflammatory and analgesic properties of chlorella, this double-blind, randomized, placebo controlled clinical trial aimed to evaluate the effects of Chlorella supplementation on the severity of menstrual pain in a group of young women with primary dysmenorrhea. STUDY DESIGN: In this clinical trial, 44 girls with primary dysmenorrhea were randomly divided into intervention and control groups. Patients in the intervention group received 1500 mg/day of chlorella as 5 soft gel and the control group received placebo soft gels for eight weeks. Menstrual and food information were collected using a previously validated and published questionnaire. Anthropometric measurements and biochemical parameters including prostaglandin E2 (PGE2), ProstaglandinF2a (PGF2a), high-sensitivity C-reactive protein (hs-CRP) and malondialdehyde (MDA) were assessed at baseline and end of week eight. RESULTS: In chlorella supplemented group the PGE2, PGF2a, hs-CRP and MDA decreased significantly (P < 0.05). The severity and duration of dysmenorrheal pain were significantly reduced in the intervention group compared to the control group (p < 0.05). Systemic symptoms of dysmenorrhea (fatigue, headache, nausea, vomiting, lack of energy) decreased in the chlorella group (p < 0.05). The mean of menstrual characteristics, anthropometric indices and daily energy and macronutrient intake in both intervention and control groups were not changed significantly. CONCLUSION: This study showed that chlorella supplementation could decrease the severity of pain and systemic symptoms and improve serum levels of prostaglandins, inflammatory and oxidative markers in women with primary dysmenorrhea.

Blood pressure lowering and anti-inflammatory effects of hesperidin in type 2 diabetes; a randomized double-blind controlled clinical trial.

Elevated levels of reactive oxygen species under diabetic condition lead to vascular complications and inflammation. This study aimed to examine the effects of hesperidin supplement on blood pressure and inflammatory markers in type 2 diabetes. In this research, 64 patients were randomly allocated to receive 500 mg/day hesperidin or placebo capsules for 6 weeks. Data on systolic blood pressure (SBP), diastolic blood pressure, serum total antioxidant capacity (TAC), tumor necrosis factor alpha, interleukin 6 (IL-6), and high-sensitivity C-reactive protein (hs-CRP) were collected at the baseline and at the end of the study. In the hesperidin group, SBP (122.7 ± 8.5 vs. 119.0 ± 7.4; p = .005), mean arterial blood pressure (94.2 ± 5.5 vs. 91.8 ± 5.5; p = .009), IL-6 (8.3 ± 2.1 vs. 7.4 ± 1.8; p = .001), and hs-CRP (1.9 ± 1.2 vs. 1.1 ± 0.9; p < .000) decreased whereas TAC increased (0.74 ± 0.1 vs. 0.82 ± 0.1; p < .000) in comparison to the baseline values. There was a significant difference in mean percent change of SBP, diastolic blood pressure, mean arterial blood pressure, serum TAC, and inflammatory markers (tumor necrosis factor alpha, IL-6, and hs-CRP) between hesperidin and control groups following intervention in adjusted models (p < .05). These results suggest that hesperidin may have antihypertensive and anti-inflammatory effects in type 2 diabetes.

Energy restriction combined with green coffee bean extract affects serum adipocytokines and the body composition in obese women.

BACKGROUND AND OBJECTIVES: Obesity has become a public health problem and is a cause of some preventable illnesses. Among several methods for treating obesity, the use of food supplements is highly common. A commonly used food supplement is green coffee bean extract. The objective of this study was to evaluate the efficacy of green coffee bean extract combined with an energy-restricted diet on the body composition and serum adipocytokines in obese women. METHODS AND STUDY DESIGN: In this randomised clinical trial, 64 obese women aged 20-45 years were selected and divided into two groups: an intervention group (receiving 400 mg green coffee bean extract for 8 weeks) and control group (receiving placebo). All participants were on an energy-restricted diet. The body composition, leptin, adiponectin, lipid profile, free fatty acids (FFAs), and fasting blood sugar were compared between the two groups. RESULTS: We observed significant reductions in the body weight, body mass and fat mass indices, and waist-to-hip circumference ratio in both groups; however, the decrease was higher in the intervention group. Moreover, serum total cholesterol, low-density lipoprotein, leptin, and plasma free fatty acids significantly decreased in the intervention group (p<0.05) after adjustment for energy and fibre intake. The serum adiponectin concentration significantly increased in the intervention group (p<0.05). CONCLUSIONS: Green coffee bean extract combined with an energy-restricted diet affects fat accumulation and lipid metabolism and is thus an inexpensive method for weight control in obese people.