Studies on humans with diabetes mellitus showed that the crosstalk between the intestinal microbiota and the host has a key role in controlling the disease. The aim of this study was to evaluate the effects of sodium butyrate and high performance inulin supplementation simultaneously or singly on glycemic status, lipid profile, and glucagon-like peptide 1 level in adults with type 2 diabetes mellitus. Sixty patients were recruited for the study. The participants were randomly allocated, using randomized block procedure, to one of the four treatment groups (A, B, C, or D). Group A received sodium butyrate capsules, group B received inulin supplement powder, group C was exposed to the concomitant use of inulin and sodium butyrate, and group D consumed placebo for 45 consecutive days. Markers of glycemia, lipid profile, and glucagon-like peptide 1 were measured pre- and post-intervention. Dietary supplementation in groups A, B, and C significantly reduced diastolic blood pressure in comparison with the placebo group (p<0.05). Also, intra-group statistical analysis showed that only treatment with sodium butyrate + inulin (group C) significantly reduced fasting blood sugar (p=0.049) and waist to hip ratio (p=0.020). Waist circumference in groups B and C reduced significantly after the intervention (p=0.007 and p=0.011; respectively). The post hoc Tukey tests showed significant increase in glucagon-like peptide 1 concentration in groups A and C in comparison with group D (p<0.05). The results suggest that inulin supplementation may be useful to diabetic patients and these effects could be increased with butyrate supplement.

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the pineal gland [11, 12]. It is known that melatonin is responsible for regulation of circadian rhythms, immune responses and mood, and reduces oxidative stress [13-16]. The roles of melatonin in obesity management have been studied in animal models of diet-induced obesity. These studies reported that melatonin might

The aim of the present study was to determine the effects of Nigella sativa (NS) oil concurrent with a low-calorie diet on lipid peroxidation and oxidative status in obese women. In this double-blind placebo-controlled randomized clinical trial, 50 volunteer obese (body mass index = 30-35 kg/m(2)) women aged 25-50 years old were recruited. Participants were randomly divided into intervention (n = 25) and placebo (n = 25) groups. They received a low-calorie diet with 3 g/day NS oil or low-calorie diet with 3 g/day placebo for 8 weeks. Forty-nine women (intervention group = 25; placebo group = 24) completed the trial. NS oil concurrent with a low-calorie diet decreased weight in the NS group compared to the placebo group (-4.80 ± 1.50 vs. -1.40 ± 1.90 kg; p < 0.01). Comparison of red blood cell superoxidase dismutase (SOD) indicated significant changes in the NS group compared to the placebo group at the end of the study (88.98 ± 87.46 vs. -3.30 ± 109.80 U/gHb; p < 0.01). But no significant changes in lipid peroxidation, glutathione peroxidase, and total antioxidant capacity concentrations were observed. NS oil concurrent with a low-calorie diet decreased weight and increased SOD levels in obese women. However, more studies are suggested to confirm the positive effects of NS in obesity and its complications.

Obesity is typically associated with increased risk factors of cardiovascular diseases (CVDs). Therefore, a therapeutic approach that aims to control body weight and metabolic profile might be effective in preventing CVDs. We aimed to determine the effects of Nigella Sativa (NS) oil with a low-calorie diet on cardiometabolic risk factors in obese women. In this double-blind randomized controlled clinical trial, 90 obese women were recruited. Participants were females aged 25-50 years old with body mass index (BMI) between 30 and 35 kg m(-2). They were randomly assigned to receive a low-calorie diet with 3 g per day (1 g before each meal) NS oil or placebo for 8 weeks. Anthropometric indices, dietary intake and biochemical parameters were measured at the baseline and after the intervention. Eighty-four females completed the trial (intervention n = 43, placebo n = 41). Two groups were similar in the baseline characteristics. After the intervention, dietary intake was changed in both groups compared to the baseline, but the differences were not significant between the two groups. In the NS group, weight (-6.0 vs. -3.6%; p < 0.01) and waist circumference (-6.9 vs. -3.4%; p < 0.01) decreased significantly compared with the placebo group at the end of the trial. Comparison of biochemical parameters presented a significant decline in triglyceride (-14.0 vs. 1.4%; p = 0.02) and very low density lipoprotein (-14.0 vs. 7%; p < 0.01) levels in the NS group compared to the placebo group. NS oil concurrent with a low-calorie diet can reduce cardiometabolic risk factors in obese women. However, more clinical trials are needed to elucidate efficacy of NS as a complementary therapy in obese subjects.