Synbiotic as an ameliorating factor in the health-related quality of life in women with polycystic ovary syndrome. A randomized, triple-blind, placebo-controlled trial.

BACKGROUND: There are complicated mechanisms that link the disruption of the gut microbiome to the symptoms and complications of polycystic ovary syndrome (PCOS). In this study, an attempt was made to assess the effects of synbiotics on the health-related quality of life (HRQoL) in women with PCOS . METHODS: Fifty-six women with PCOS were enrolled in a triple-blind controlled trial for 12 weeks. They were randomly assigned to receive a daily 2-gram synbiotic sachets (containing Bacillus coagulans (GBI-30), Lactobacillus rhamnosus, Lactobacillus helveticus, and fructooligosaccharide) (n = 28) or placebo (n = 28). To evaluate the impact on the HRQoL, participants were required to fill 26-Item Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ-26), 12-Item Short-Form Health Survey (SF-12) and Perceived Stress Scale (PSS-10) pre and post the intervention. RESULTS: Finally, statistical analyses were performed on 52 participants who finished the trial. Synbiotic supplementation improved the scores of emotional (P = 0.044), body hair (P = 0.016), weight (P = 0.033) and infertility domains (P = 0.027) of PCOSQ-26 compared to placebo group. The physical score within SF-12 also had a significant enhancement (P = 0.035). No significant improvement was seen in the PSS-10 score at the end of the trial. CONCLUSION: This study illustrated the advantageous effects of synbiotics on the health-related quality of life in women with PCOS. Further studies are required to confirm our findings. TRIAL REGISTRATION: http://www.irct.ir : IRCT20211108053007N1; date of registration: 14/02/2023.

The effect of soy isoflavones supplementation on metabolic status in patients with non-alcoholic fatty liver disease: a randomized placebo controlled clinical trial.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) accounts as a crucial health concern with a huge burden on health and economic systems. The aim of this study is to evaluate the effect of soy isoflavones supplementation on metabolic status in patients with NAFLD. METHODS: In this randomized clinical trial, 50 patients with NAFLD were randomly allocated to either soy isoflavone or placebo groups for 12 weeks. The soy isoflavone group took 100 mg/d soy isoflavone and the placebo group took the similar tablets containing starch. Anthropometric indices, blood lipids, glycemic parameters and blood pressure were measured at the beginning and at the end of the study. RESULTS: At the end of week 12 the level of serum triglyceride (TG), low density lipoprotein (LDL) and total cholesterol (TC) was significantly decreased only in soy isoflavone group compared to baseline (P < 0.05). Although waist circumference (WC) decreased significantly in both groups after 12 weeks of intervention (P < 0.05), hip circumference (HC) decreased significantly only in soy isoflavone group (P = 0.001). No significant changes observed regarding high density lipoprotein (HDL) and blood pressure in both groups. At the end of the study, serum glucose level was significantly decreased in the placebo group compared to baseline (P = 0.047). No significant changes demonstrated in the soy isoflavone group in regard to glycemic parameters (P > 0.05). CONCLUSIONS: This study revealed that soy isoflavones could significantly reduce TG, LDL TC, WC and HC in NAFLD patients. TRIAL REGISTRATION: The Ethics committee of Ahvaz Jundishapur University of Medical Sciences approved the protocol of the present clinical research (IR.AJUMS.REC.1401.155). The study was in accordance with the Declaration of Helsinki. This study's registered number and date are IRCT20220801055597N1 and 20.09.2022, respectively at https://fa.irct.ir .

Dietary inflammatory index and risk of gallstone disease in Iranian women: a case-control study.

BACKGROUND: Considering inflammation as a primary occurrence in gallstone formation, this study aimed to determine the relation between serum biomarkers of inflammation and oxidative stress, and dietary Inflammatory Index (DII) score with the risk of gallstone disease (GD) among Iranian women. MATERIALS AND METHODS: Present BMI-matched case-control study was performed among 75 women with GD and 75 healthy controls. Biochemical parameters were measured by standard laboratory methods. A validated food frequency questionnaire (FFQ) was used to assess the usual intake of participants. DII score was calculated for all participants. The linear and logistic regression were used to examine the association of DII with serum inflammatory biomarkers and the odds ratio of GD, respectively. RESULTS: The mean serum levels of high-sensitivity C-reactive protein (hs-CRP) and Malondialdehyde (MDA) were significantly (P < 0.001) higher in GD patients compared to control subjects. Women in the highest tertile of DII compared to the lowest tertile had lower intake of macronutrients, minerals, vitamins garlic, onion, pepper and fiber. Moreover, the odd of GD was significantly higher in the third tertile of the DII versus the first tertile after adjustment of potential confounders (OR: 17.47; 95% CI: 4.64-65.72). Also, a positive and significant relationship was found between the serum level of inflammatory biomarkers with the risk of GD and the inflammatory score of the diet (P < 0.001). CONCLUSION: Our data indicate that higher DII score, and serum inflammatory and oxidative stress biomarkers are related to higher risk of GD in Iranian women.

Dietary fiber intake and risk of gallstone: a case-control study.

BACKGROUND: Gallstone disease (GSD) and its complications are major public health issues globally. Although many community-based studies had addressed the risk factors for GSD, little is known about the associations between dietary factors and risk of disease. The present study aimed to investigate the potential associations between dietary fibers with the risk of gallstone disease. METHODS: In this case-control study, 189 GSD patients with less than one month of diagnosis and 342 age­matched controls were enrolled. Dietary intakes were assessed using a 168-item semi-quantitative validated food frequency questionnaire. Crude and multivariable-adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated through cox proportional hazards regression models. RESULTS: Comparing the highest versus the lowest tertile, significant reverse associations were observed between odds of GSD and each category of dietary fiber intake including total (OR T3 vs. T1 = 0.44, 95% CI: 0.37-0.7, P for trend = 0.015), soluble (OR T3 vs. T1 = 0.51, 95% CI: 0.3-0.8, P for trend = 0.048) and insoluble (OR T3 vs. T1 = 0.56, 95% CI: 0.3-0.9, P for trend < 0.001). The relationship between dietary fiber intake and the risk of gallstones was more prominent in overweight and obese subjects than in subjects with a normal body mass index. CONCLUSION: Comprehensive assessment of the associations of dietary fiber intake with GSD showed that higher intakes of dietary fiber were significantly associated with reduced GSD risk.

Dietary protein intake and mortality among survivors of liver cirrhosis: a prospective cohort study.

BACKGROUND: Liver cirrhosis is a worldwide burden and is associated with poor clinical outcomes, including increased mortality. The beneficial effects of dietary modifications in reducing morbidity and mortality are inevitable. AIM: The current study aimed to evaluate the potential association of dietary protein intake with the cirrhosis-related mortality. METHODS: In this cohort study, 121 ambulatory cirrhotic patients with at least 6 months of cirrhosis diagnosis were followed-up for 48 months. A 168-item validated food frequency questionnaire was used for dietary intake assessment. Total dietary protein was classified as dairy, vegetable and animal protein. We estimated crude and multivariable-adjusted hazard ratios (HRs) with 95% confidence intervals (CIs), applying Cox proportional hazard analyses. RESULTS: After full adjustment for confounders, analyses showed that total (HR = 0.38, 95% CI = 0.2-1.1, p trend = 0.045) and dairy (HR = 0.38, 95% CI = 0.13-1.1, p trend = 0.046) protein intake was associated with a 62% lower risk of cirrhosis-related mortality. While a higher intake of animal protein was associated with a 3.8-fold increase in the risk of mortality in patients (HR = 3.8, 95% CI = 1.7-8.2, p trend = 0.035). Higher intake of vegetable protein was inversely but not significantly associated with mortality risk. CONCLUSION: A comprehensive evaluation of the associations of dietary protein intake with cirrhosis-related mortality indicated that a higher intakes of total and dairy protein and a lower intakes of animal protein are associated with a reduced risk of mortality in cirrhotic patients.

Effect of time restricted feeding on anthropometric measures, eating behavior, stress, serum levels of BDNF and LBP in overweight/obese women with food addiction: a randomized clinical trial.

BACKGROUND & AIM: Food addiction (FA) as a specific food-related behavior may play an essential role in the pathogenesis of obesity. Brain-derived neurotrophic factor (BDNF) and gut microbiota (GM) alterations probably through fasting are closely related to brain function, affecting eating behaviors and body weight management. This study aimed to evaluate the effect of time-restricted feeding (TRF) on serum BDNF levels and eating behaviors in overweight and obese women with FA. METHODS AND DESIGN: This clinical trial was performed with a 2-month follow-up on 56 obese and overweight women with FA. Participants were randomly divided into two groups receiving a low-calorie diet (n = 27) and a group receiving a low-calorie diet with TRF (n = 29). Anthropometric measurements, biochemical markers, eating behavior, and stress were assessed during the study period. RESULTS: The reductions in weight, body mass index (BMI), waist circumference, and body fat mass were significantly higher in the TRF group compared to the control group at week 8 (P = 0.018, P = 0.015. P = 0.03, and P = 0.036, respectively). The cognitive restriction score was higher in the TRF as compared with the control group (P = 0.002). The food addiction criteria score was significantly reduced in both groups (P < 0.001). Serum levels of BDNF were significantly increased in the TRF group (P < 0.001). In addition, BDNF levels had a positive and significant correlation with the cognitive restriction score (r = 0.468 and P < 0.001), While the correlation with FA was not significant (ß = 0.588 and P = 0.618). Lipopolysaccharide binding protein decreased significantly in both groups, but this decrease was significantly higher in the TRF group than in the control group (P < 0.001). CONCLUSION: The results of this study showed that a low-calorie diet with TRF is more effective in weight management than a low-calorie diet alone, probably through further modulating the GM and improving BDNF levels. More effective weight loss in the TRF is probably related to better management of eating behavior than FA. TRIAL REGISTRATION: Iranian Registry of Clinical Trials identifier: IRCT20131228015968N7.

Probiotics and synbiotics supplementation improve glycemic control parameters in subjects with prediabetes and type 2 diabetes mellitus: A GRADE-assessed systematic review, meta-analysis, and meta-regression of randomized clinical trials.

Probiotics and synbiotics have been proposed to exhibit an important role in glucose homeostasis and maintain the balance of the gut microbiota. However, clinical trials have shown mixed findings. Therefore, we conducted a systematic review and meta-analysis of all eligible randomized controlled trials (RCTs) examining the effects of probiotics and synbiotics intake on glycemic outcomes among individuals with prediabetes and type 2 diabetes mellitus (T2DM). The PubMed/Medline, Scopus, ISI Web of Science, and Cochrane library were searched up to March 2022 for published RCTs exploring the effectiveness of probiotics and synbiotics compared to control on glycemic outcomes. The random-effects model was applied in order to the estimation of 95 % confidence interval (CI) and the weighted mean difference (WMD) for each endpoint. Meta-analysis of forty-six RCTs (3067 participants) showed that probiotics and synbiotics supplementation significantly reduced fasting plasma glucose (FPG) (weighted mean difference (WMD): - 11.18 mg/dl, 95 % CI: - 13.60, - 8.75, p ˂0.001), fasting insulin serum level (WMD: -1.23 µIU/ml, 95 % CI: -1.76, -0.71, p ˂0.001), hemoglobin A1c (HbA1c) (WMD: -0.35 %, 95 % CI: -0.44, -0.26, p˂0.001), and homeostatic model assessment of insulin resistance (HOMA-IR) (WMD: -0.87, 95 % CI: -1.09, -0.65, p˂0.001). Additionally, probiotics and synbiotics intake resulted in an increase in values of quantitative insulin-sensitivity check index (QUICKI) (WMD: 0.01, 95 % CI: 0.00, 0.01, p˂0.001). However, probiotics and synbiotics consumption did not change glucose values following oral glucose tolerance test (OGTT). Our findings suggest that probiotic and synbiotic intake has favorable effects on glycemic profile in patients with prediabetes and T2DM.

Beneficial effects of probiotic and synbiotic supplementation on some cardiovascular risk factors among individuals with prediabetes and type 2 diabetes mellitus: A grade-assessed systematic review, meta-analysis, and meta-regression of randomized clinical trials.

Previous studies suggested that probiotics/synbiotics administration exerts some beneficial effects on cardiometabolic risk factors. However, the results from trials have been inconsistent. This study aimed to identify the impact of probiotic and synbiotic supplements on cardiovascular health factors in patients with type 2 diabetes mellitus (T2DM) and prediabetes We searched PubMed/MEDLINE, Web of Science, and Scopus up to February 2022 to identify eligible RCTs. Estimating 95 % confidence (CI) and the weighted mean difference (WMD) for weight, body mass index (BMI), waist circumferences (WC), triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP), and diastolic blood pressure (DBP), the random-effects model was used. In the current meta-analysis, 54 RCTs were included. With the probiotic/synbiotics intervention, several parameters changed significantly, including weight (WMD: -0.38, 95 % CI: -0.63 to -0.12 Kg), TG (WMD: -19.08, 95 % CI: -27.65 to -10.51 mg/dl), TC (WMD: -10.46, 95 % CI: -15.19 to -5.72 mg/dl), LDL-C (WMD: -4.87, 95 % CI: -7.65 to -2.09 mg/dl), HDL-C (WMD: -2.70, 95 % CI: 1.33-4.07 mg/dl), SBP (WMD: -3.81, 95 % CI: -6.24 to -1.38 mmHg), and DBP (WMD: -2.01, 95 % CI: -3.12 to -0.91 mmHg). In the subgroup analysis, probiotics/synbiotics supplementation resulted in a greater change in lipid profile components in T2DM patients. Weight and BMI reduced only after synbiotic supplementation. We found that the administration of probiotics and synbiotics had beneficial effects on lipid profiles, anthropometric indices, and blood pressure in individuals with T2DM.

A review on differential effects of dietary fatty acids on weight, appetite and energy expenditure.

The association between weight and chronic diseases is well defined. The quality and quantity of dietary fatty acids is an important external factor and appetite and energy expenditure, are important internal factors in determining body weight. On the other hand, dietary fatty acids composition can modulate appetite and energy metabolism, but not all fats are equal in producing metabolic responses.Given the accumulating evidence for differential effects of various dietary fatty acids, one important area of investigation is to scrutinize their roles in weight, appetite and energy expenditure modulation. There is substantial evidence to suggest that saturated fatty acids have a greater effect on appetite control, although in the long run may result in more weight gain than unsaturated fatty acids due to a weaker stimulation of energy expenditure. In contrast, mono-unsaturated fats do not have much effects on appetite control, but they can be beneficial in weight control over the long term due to stimulatory effects on energy expenditure. Interestingly, in case of poly unsaturated fats, including n-3 and n-6, their effect on increasing energy expenditure is aligned, but they act differently in controlling weight and appetite.

Flaxseed supplementation improves anthropometric measurements, metabolic, and inflammatory biomarkers in overweight and obese adults.

Background: The aim of this study was to assess the effects of supplementation with flaxseed on anthropometric measurements, lipid profile, insulin resistance, and inflammatory biomarkers in overweight and obese adults. Methods: Fifty overweight and obese adults with body mass index (BMI) of 30.72 ± 3.31 kg/m2 participated in this study. Participants were randomly assigned to take lifestyle advice or lifestyle advice plus 30 g/day milled flaxseed for 12 weeks. The primary outcome was body weight; secondary outcomes included other anthropometric parameters, lipid profile and inflammatory biomarkers. Results: At the end of the study, the following significant mean differences were seen in flaxseed and control groups, respectively: weight [-9.36 vs. -3.09 kg; P < 0.001], BMI [-3.34 vs. -1.2 kg/m2; P < 0.001], triglycerides [-62.88 vs. -9.85 mg/dL; P < 0.001], total cholesterol [-32.2 vs. -14.95 mg/dL; P = 0.04], homeostatic model assessment (HOMA-IR) [1.25 vs. -0.32; P = 0.024], high sensitive- C reactive protein [-2.2 vs. -1.01 mmol/L; P < 0.001] and tumor necrosis factor-α [-1.34 vs. -0.14 pg/mL; P = 0.005]. Conclusion: These results suggest that flaxseed supplementation in addition to lifestyle modification is significantly superior to lifestyle modification alone for weight loss. More studies with different dosages of flaxseed are needed to find the optimal dosage. This trial was registered at clinicaltrials.gov as NCT02410668.

Flaxseed and/or hesperidin supplementation in metabolic syndrome: an open-labeled randomized controlled trial.

PURPOSE: The aim of the present study was to compare the clinical effect of flaxseed and hesperidin alone and with combination in patients with metabolic syndrome. Number of participants with treated metabolic syndrome was assessed as a primary end point. METHODS: In this 12-week randomized controlled trial, ninety-eight patients with metabolic syndrome randomly assigned to receive either whole flaxseed powder (30 g/day), or hesperidin (1 g/day), or combination of 30 g flaxseed and 1 g hesperidin or no supplement while adhering a lifestyle modification program. RESULTS: In comparison to control group, systolic blood pressure (- 5.68 vs. - 2.91 mmHg, P = 0.041) and serum concentrations of triglyceride (- 50.06 vs. 3.87 mg/dL, P = 0.033) in hesperidin group showed a significant reduction over 12 weeks of intervention. Comparison of the results of flaxseed group with the control group showed a significant improvement in serum concentrations of triglyceride (- 66 vs. 3.87 mg/dL, P = 0.028), insulin (- 4.27 vs. - 2.51 mU/L, P = 0.003) and accordingly insulin resistance (- 1.19 vs. - 0.76, P = 0.005) and sensitivity (0.03 vs. 0.01, P = 0.022) indices in flaxseed group. Combination of flaxseed and hesperidin improved three of five metabolic syndrome components including serum concentrations of triglyceride, glucose and systolic blood pressure as compared to placebo. Interestingly, co-administration of flaxseed and hesperidin with 77.3% reduction in the prevalence of defined metabolic syndrome was revealed to be most effective in controlling the metabolic syndrome, after which the group of flaxseed with 76% reduction and hesperidin group with 54.5% reduction were ranked second and third, respectively. CONCLUSIONS: It can be concluded that co-administration of flaxseed and hesperidin appears to be superior to either supplementation alone on metabolic syndrome treatment, while the effects of flaxseed are stronger than hesperidin supplementation.

The effect of hesperidin supplementation on metabolic profiles in patients with metabolic syndrome: a randomized, double-blind, placebo-controlled clinical trial.

PURPOSE: Hesperidin as an antioxidant flavonoid exerts anti-adipogenic, anti-inflammatory, anti-oxidant and anti-hypercholesterolemic effects. Besides, the increasing prevalence of metabolic syndrome (MetS) and its allied complications, on the one hand, and the willingness of individuals to use natural products for curing their diseases, on the other hand, led to the design of this study to evaluate the efficacy of hesperidin in normalizing the metabolic abnormalities in patients with MetS. METHODS: In this clinical trial with a parallel-group design, 49 patients with MetS received either 500-mg hesperidin or placebo, twice daily, for 12 weeks. Number of participants with treated MetS was considered as a primary end point. Anthropometric parameters, dietary intake, physical activity, lipid profile, glucose homeostasis parameter, tumor necrosis factor alpha (TNF-α), high-sensitivity C-reactive protein (hs-CRP) were assessed at the beginning and at the end of the study. This trial is registered at clinicaltrials.gov as NCT03734874. RESULTS: Compared with the placebo group, hesperidin decreased fasting glucose level (- 6.07 vs. - 13.32 mg/dL, P = 0.043), triglyceride (- 8.83 vs. - 49.09 mg/dL, P = 0.049), systolic blood pressure (- 0.58 vs. - 2.68 mmHg, P = 0.048) and TNF-α (- 1.29 vs. - 4.44 pg/mL, P = 0.009). Based on the within-group analysis, hesperidin led to significant decrease in serum levels of glucose, insulin, triglyceride, total cholesterol, low density lipoprotein cholesterol, TNF-α and hs-CRP, while in control group only glucose and insulin significantly decreased. CONCLUSIONS: The results indicate that hesperidin supplementation can improve metabolic abnormalities and inflammatory status in patients with MetS.

Is Bacillus coagulans supplementation plus low FODMAP diet superior to low FODMAP diet in irritable bowel syndrome management?

PURPOSE: The aim of this study was to assess the superiority of low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) diet plus Bacillus coagulans supplementation to low FODMAP diet alone in the reduction of irritable bowel syndrome (IBS) symptoms. METHODS: In this randomized clinical trial, fifty IBS patients who met Rome IV criteria for IBS were randomly assigned to receive a low FODMAP diet plus either a probiotic or a placebo capsule for 8 weeks. Probiotic capsules contained 109B. coagulans spores and 400 mg inulin, while placebo capsules consisted of 500 mg rice starch. RESULTS: Significant improvements were observed in abdominal pain intensity and frequency, abdominal distension, satisfaction with bowel habits, quality of life, defecation consistency, and patient-reported severity score in both groups; however, only improvement in severity score was significantly higher in probiotic group compared with placebo group (P = 0.001). Moreover, the frequency of patients with clinical improvement in IBS-symptom severity scale (IBS-SSS) was significantly more in probiotic group compared to placebo group (P = 0.038). CONCLUSION: Our results indicate that the addition of probiotic supplement containing B. coagulans to the low FODMAP diet might be superior to low FODMAP diet in alleviating IBS symptoms.

Effects of soy isoflavones on serum lipids and lipoprotein (a) in peritoneal dialysis patients.

BACKGROUND AND AIM: Lipid abnormalities are common in peritoneal dialysis (PD) patients and no effective treatment to decrease serum lipoprotein (a) [Lp(a)] in dialysis patients is known so far. Therefore, this research was designed to investigate the effects of soy isoflavone supplement on serum lipids and Lp(a) in PD patients. METHODS & RESULTS: In this randomized, double-blind, placebo-controlled trial, 40 PD patients were randomly assigned to either the isoflavone or the placebo group. The patients in the isoflavone group received 100 mg soy isoflavone daily for 8 weeks, whereas the placebo group received corresponding placebos. At baseline and the end of the 8th week, 7 mL of blood was obtained from each patient and serum triglycerides, total cholesterol, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and Lp(a) were measured. Serum Lp(a) reduced significantly up to 10% in the isoflavone group at the end of week 8 compared to baseline (P < 0.05), and the reduction was significant in comparison with the placebo group (P < 0.05). Serum HDL-C increased significantly up to 11.5% in the isoflavone group at the end of week 8 compared to baseline (P = 0.05), and the increment was significant in comparison with the placebo group (P < 0.05). There were no significant differences between the two groups in mean changes of serum triglycerides, total cholesterol, and LDL-C. CONCLUSIONS: This study indicates that daily administration of 100 mg soy isoflavones reduces serum Lp(a) and increases HDL-C concentration which are two determinants of cardiovascular disease in PD patients. CLINICALTRIALS.GOV: NCT03773029. REGISTRATION NUMBER AND DATE: NCT03773029 - 2018.

Effects of soy isoflavones on serum systemic and vascular inflammation markers and oxidative stress in peritoneal dialysis patients: A randomized controlled trial.

Cardiovascular disease (CVD) is common in peritoneal dialysis (PD) patients. This study was designed to investigate the effects of isoflavones on systemic and vascular inflammation markers and oxidative stress in PD patients. In this randomized clinical trial, 40 PD patients were randomly assigned to either the isoflavone or the placebo group. The isoflavone group received 100 mg soy isoflavones daily for 8 weeks, whereas the placebo group received corresponding placebos. At baseline and the end of eighth week, serum high sensitive C-reactive protein (hs-CRP), intercellular adhesion molecule type 1 (ICAM-1), vascular cell adhesion molecule type 1 (VCAM-1), E-selectin, and malondialdehyde were measured. Serum VCAM-1 decreased significantly in the isoflavone group at the end of Week 8 compared to baseline (p = .01), whereas no significant change was observed in the placebo group. Serum ICAM-1 decreased significantly in the isoflavone (p = .01) and placebo (p = .01) group compared to baseline. However, the reduction of ICAM-1 was significantly higher in the isoflavone group than in the placebo group (p = .02). There were no significant differences between the two groups in mean changes of serum E-selectin, malondialdehyde, and hs-CRP. This study indicates that isoflavones reduce serum VCAM-1 and ICAM-1, which are two CVD risk factors, in PD patients.

Curcumin and inflammation in non-alcoholic fatty liver disease: a randomized, placebo controlled clinical trial.

BACKGROUND: The aim of the present study was to evaluate the effects of curcumin supplementation on inflammatory indices, and hepatic features in patients with non-alcoholic fatty liver disease (NAFLD). METHODS: Fifty patients with NAFLD were randomized to receive lifestyle modification advice plus either 1500 mg curcumin or the same amount of placebo for 12 weeks. RESULTS: Curcumin supplementation was associated with significant decrease in hepatic fibrosis (p < 0.001), and nuclear factor-kappa B activity (p < 0.05) as compared with the baseline. Hepatic steatosis and serum level of liver enzymes, and tumor necrosis-α (TNF-α) significantly reduced in both groups (p < 0.05). None of the changes were significantly different between two groups. CONCLUSION: Our results indicated that curcumin supplementation plus lifestyle modification is not superior to lifestyle modification alone in amelioration of inflammation. TRIAL REGISTRATION: IRCT20100524004010N24, this trial was retrospectively registered on May 14, 2018.

The effects of two vitamin D regimens on ulcerative colitis activity index, quality of life and oxidant/anti-oxidant status.

BACKGROUND: The optimum dosage for vitamin D supplementation has not yet been elucidated in patients with Ulcerative colitis (UC). The aim of this study was to investigate the effects of two vitamin D regimens in UC patients with vitamin D deficiency. METHODS: In this double blind randomized clinical trial, 50 patients with mild to moderate UC, who met inclusion criteria, received either 1000 or 2000 IU/day of vitamin D (as low dose or high dose group, respectively) for 12 weeks. Serum 25-hydroxy vitamin D (25-OHD) level, total antioxidant capacity (TAC), and Total Oxidant Status (TOS), the inflammatory bowel disease questionnaire - 9 (IBDQ-9) score and the Simple Clinical Colitis Activity Index Questionnaire (SCCAI) score were assessed before and after intervention. RESULTS: At the end of study, serum 25-OHD levels significantly increased in the high dose group (P < 0.001) and the increase was significantly more than low dose group (6.7 ± 3.8 ng/mL in the high dose group versus 0.2 ± 0.5 ng/mL in the low dose group) (P < 0.001). Serum TOS concentration decreased significantly (- 0.37 ± 0.26) only in the high dose group (P value = 0.023). There was no statistically significant change in serum TAC between two groups during the study. IBDQ-9 mean score significantly increased in high dose group compared to the low dose group (P value = 0.001) and SCCAI score in both groups reduced (- 2.58 ± 2.16 and - 0.9 ± 0.3 in high dose and low dose respectively), while this reduction was significant only in the high dose group (P value ≥0.001). CONCLUSION: Our results indicate that 2000 IU daily dose of vitamin D can increase serum 25-OHD concentration, and quality of life, while it reduces disease activity in UC patients with vitamin D deficiency. We recommend assessment of the vitamin D status in all patients with UC because they may benefit from vitamin D therapy.

The effects of black seed supplementation on cardiovascular risk factors in patients with nonalcoholic fatty liver disease: A randomized, double-blind, placebo-controlled clinical trial.

Nonalcoholic fatty liver disease (NAFLD) is highly related to cardiovascular disorders risk factors. This study aimed to evaluate the effects of black seed (Nigella sativa) supplementation on cardiovascular disorders risk factors in patients with NAFLD. This randomized, double-blind, placebo-controlled clinical trial was conducted on 50 patients with NAFLD. Participants were assigned to receive a lifestyle modification plus 2 g/day of either N. sativa or placebo for 12 weeks. Compared with the placebo, N. sativa supplementation led to significant reductions in serum glucose (-7.95 vs. -1.22; p = .041), serum insulin (-3.87 vs. -1.07; p = .027), homeostatic model of assessment for insulin resistance (-1.02 vs. -0.28; p = .021), and a significant increase in quantitative insulin sensitivity check index (0.03 vs. 0.006; p = .002). All of these changes were remained significant after adjusting for known confounding variables; however, there was no significant difference in lipid profile changes between the two groups (p = .05). N. sativa supplementation significantly decreased hepatic steatosis percentage compared with the placebo after adjustment for confounding variables (p = .005). In conclusion, our results indicate that daily intake of 2-g N. sativa plus lifestyle modification is superior to lifestyle modification alone in amelioration of insulin resistance and hepatic steatosis in patients with NAFLD.

Hesperidin improves hepatic steatosis, hepatic enzymes, and metabolic and inflammatory parameters in patients with nonalcoholic fatty liver disease: A randomized, placebo-controlled, double-blind clinical trial.

This study aimed to evaluate the effects of hesperidin on nonalcoholic fatty liver disease (NAFLD) characteristics. In this randomized, double-blind, controlled clinical trial, 50 NAFLD patients were supplemented with either 1-g hesperidin capsule or identical placebo capsule for 12 weeks. During the intervention, both groups were advised to follow healthy lifestyle habits including dietary and physical activity recommendations. At the end of the study, hesperidin supplementation, compared with placebo, was associated with a significant reduction in alanine aminotransferase (p = .005), γ-glutamyltransferase (p = .004), total cholesterol (p = .016), triglyceride (p = .049), hepatic steatosis (p = .041), high-sensitivity C-reactive protein (p = .029), tumor necrosis factor-α, and nuclear factor-κB (NF-κB). In conclusion, our results indicate that hesperidin supplementation accompanied with lifestyle modification is superior to lifestyle modification alone in management of NAFLD at least partially through inhibiting NF-κB activation and improving lipid profile. Further studies with higher dose of hesperidin are required to find the optimal dose.

Investigation of different concentrations of MS media effects on gene expression and steviol glycosides accumulation in Stevia rebaudiana Bertoni.

Stevia rebaudiana Bertoni is one of two species that contains steviol glycosides. Among steviol glycosides that extracted from leaves, stevioside and rebaudioside A are the two major and the sweetest glycosides that are about 200-300 times sweeter than sucrose with zero calories. The best method for stevia propagation is tissue culture. So, for investigation of nutrients in medium, we studied the effect of different concentrations of MS media (MS, 0.5 MS, 0.25 MS, 0 MS) on morphological traits, UGT74G1 and UGT76G1 genes expression and accumulation of steviol glycosides in stevia leaves. The best growth rate (0.472 mm/d) has occurred in plants grown in MS media. Also, the highest gene expression of UGT74G1 gene (1.000 Total lab unit) was seen under MS treatment. However, the highest expression level of UGT76G1 gene (1.701 Total lab unit) was observed at plants grown in 0 MS. The highest amount of both Stevioside and Rebaudioside A (14.23 and 8.12, respectively) were accumulated in plants under MS treatment. Obviously, dilution of MS media associated with decreasing in both expression of the intended genes and accumulation of steviol glycosides.