A crossover randomized controlled trial examining the effects of black seed (Nigella sativa) supplementation on IL-1ß, IL-6 and leptin, and insulin parameters in overweight and obese women.

BACKGROUND: Nigella sativa (NS) oil has been found to have advantageous benefits in the management of inflammation and obesity. This study investigated the effect of NS supplementation on blood mRNA expressions and serum levels of IL-1ß, IL-6, leptin, and insulin concentrations in overweight/obese women. METHODS: In a crossover design, participants were randomized to receive either NS supplements(2000 mg/day) or placebo for 2 durations(8 weeks). With between-subject and within-subject components and interactions, a repeated-measure ANOVA model was used considering the treatment, time, and the carryover effects. Cohen's d(d) was used to measure the magnitude of the effects. RESULTS: Forty-six eligible participants were included. NS supplementation significantly reduced the mRNA expressions(d=-0.68, P = 0.03) and serum levels of IL-1ß with medium-high effect sizes(d=-1.6, P < 0.001). Significant reductions with large effect sizes were observed in the gene expression and serum levels of IL-6(d=-1.8, d=-0.78, respectively; P < 0.01) and Leptin(d=-1.9, d=-0.89, respectively; P < 0.01, serum leptin P carryover < 0.001). Despite the meaningful carryover effect for serum leptin, results remained significant following the first intervention period analysis(P < 0.001). A significant but low effect size decrease in serum insulin was observed(d=-0.3, P = 0.02). CONCLUSIONS: The clinical significance of present findings regarding improvements in obesity-related pro-inflammatory markers must be interpreted with caution due to some observed medium-low effect sizes. TRIAL REGISTRATION: IRCT20180430039475N1 (Date:25/6/2018).

Effect of dietary approaches to stop hypertension, and standard diets with and without curcumin on interleukin-1 alpha, 5-alpha reductase gene expressions, and androgenic and glycemic profile in polycystic ovary syndrome women undergoing in vitro fertilization treatment: A study protocol.

Background: Polycystic ovary syndrome (PCOS) is one of the most common endocrine diseases with major reproductive and metabolic complications with an impact on public health. Hyperandrogenism and chronic inflammation have been suggested as the leading cause of pathophysiology and clinical manifestations associated with PCOS. It seems that the altered expression of genes involved in the synthesis of pro-inflammatory cytokine and androgens contribute to the promotion of PCOS. Objective: This trial aims to determine the effects of dietary approaches to stop hypertension (DASH) and standard diets with and without curcumin supplementation on the gene expression of interleukin -1 alpha(IL1α), 5α reductase and androgenic and glycemic profile among PCOS patients, who are candidates for in vitro fertilization. Materials and Methods: 96 infertile women with PCOS, aged 18-40 yr, will participate in this randomized, placebo-controlled clinical trial. Based on treatment conditions and body mass index, the participants will be randomly divided into 4 equal groups using a randomized block design. They will receive a DASH or standard diet containing 52% carbohydrate, 18% protein, and 30% total fat, with the same prescribed sodium, plus 500 mg twice daily curcumin or placebo for 12 wk. The mRNA expression of IL-1α, 5α reductase, and androgenic and glycemic profiles will be measured at baseline and at the end of the study. Conclusion: Concomitant administration of DASH diet and curcumin supplementation may reduce IL-1α, 5α reductase gene expressions, and improve glycemic and androgenic profiles.

Evaluation of the recovery after heart surgery following preoperative supplementation with a combination of beta-hydroxy-beta-methylbutyrate, L-arginine, and L-glutamine: a double-blind randomized placebo-controlled clinical trial.

BACKGROUND: The preoperative period is a good time to improve nutrition status, compensate for nutrient deficiencies, and optimize immune function in patients' underlying surgery. In some medical conditions, supplementation with a combination of L-glutamine (Gln), ß-hydroxy-ß-methylbutyrate (HMB), and L-arginine (Arg) had promising effects on improving recovery. The present study aimed to evaluate the effect of supplementation with Gln/Arg/HMB in patients undergoing heart surgery. METHODS: This randomized clinical trial was conducted on 70 patients undergoing cardiac surgery. Participants were requested to consume 2 sachets of a combination of 7 g L-arginine, 7 g L-glutamine, and 1.5 g daily HMB or placebo 30 days before operation. At the baseline and end of the study, left ventricular ejection fraction and the serum levels of troponin, creatine phosphokinase (CPK), CPK-MB, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin were measured. Also, the Sequential Organ Failure Assessment (SOFA) score, time of stay in hospital and intensive care unit (ICU), and postoperative complications were recorded after surgery. RESULTS: In total, 60 preoperative patients (30 in each group) with a mean age of 53.13 ± 14.35 years completed the study (attrition rate = 85.7%). Subjects in the Gln/Arg/HMB group had lower serum levels of CPK-MB (median [IQR] = 49 [39.75] vs. 83 [64.55]; P = 0.011), troponin (median [IQR] = 2.13 [1.89] vs. 4.34 [1.99]; P < 0.001), bilirubin (median [IQR] = 0.50 [0.20] vs. 0.40 [0.22]; P < 0.001), and SOFA score (median [IQR] = 2 [2] vs. 5 [2]; P < 0.001) at end of the study compared to the placebo. Also, the time of stay in the hospital (median [IQR] = 5 [1] vs. 6 [3]; P < 0.001) and ICU (median [IQR] = 2.50 [1.00] vs. 3.50 [1.50]; P = 0.002) was lower in the Gln/Arg/HMB group. CONCLUSION: The present study showed that perioperative supplementation with a combination of Gln, Arg, and HMB enhances the recovery, reduces myocardial injury, and decreases the time of hospital and ICU stay in cardiac surgery patients. These results need to be confirmed in a larger trial. TRIAL REGISTRATION: IRCT.ir IRCT20120913010826N31. Registered on 13 October 2020.

The effects of preoperative supplementation with a combination of beta-hydroxy-beta-methylbutyrate, arginine, and glutamine on inflammatory and hematological markers of patients with heart surgery: a randomized controlled trial.

BACKGROUND: Cardiac surgery is associated with a widespread inflammatory response, by an additional release of free radicals. Due to the importance of these patient's nutritional status, the present study was designed to evaluate the effectiveness of supplementation with a combination of glutamine, ß-hydroxy-ß-methylbutyrate (HMB) and arginine in patients undergoing to the heart surgery. METHODS: The experiment was performed in 1 month (30 days) before cardiac surgery. patients were asked to take 2 sachets of Heallagen® (a combination of 7 g L-arginine, 7 g L-glutamine, and 1.5 g daily HMB) or placebo with identical appearance and taste (maltodextrin) with 120 cc of water. Clinical and biochemical factors were evaluated in the baseline and end of the study. RESULTS: Totally, 60 preoperative patients (30 interventions and 30 placeboes) with a mean age of 53.13 ± 14.35 years participated in the study. Subjects in Heallagen® group had a lower serum levels of interleukin-6 (P = 0.023), erythrocyte sedimentation rate (P < 0.01), high sensitivity C-reactive protein (P < 0.01), and lymphocyte number (P = 0.007) compared to the placebo, at end of the study. CONCLUSION: In the patients undergoing heart surgery, Heallagen® significantly improved some of the inflammatory factors and hematological parameters. These results need to be confirmed in a larger trial. TRIAL REGISTRATION: The protocol of the study was registered in the IRCT.ir with registration no. IRCT20120913010826N31 at 13/10/2020.

The effect of L-carnitine supplementation on insulin resistance, sex hormone-binding globulin and lipid profile in overweight/obese women with polycystic ovary syndrome: a randomized clinical trial.

PURPOSE: Polycystic ovary syndrome (PCOS) is a common endocrine disorder among reproductive-age women. Insulin resistance and dyslipidemia are linked to PCOS. L-Carnitine supplementation as a management strategy for women with PCOS has been proposed. The effect of L-carnitine supplementation on insulin resistance, sex hormone-binding globulin (SHBG) and lipid profile in overweight/obese women with PCOS was investigated. METHODS: This randomized, double-blind, controlled clinical trial, was conducted on 62overweight/obese women with PCOS. Participants were randomly assigned into two groups to receive 1000 mg/day L-carnitine or placebo (1000 mg starch) for 12 weeks. RESULTS: L-Carnitine supplementation compared to the placebo showed a significant improvement in insulin [- 0.7 (- 7.3 to 4.0) vs. 0.7 (- 3.0 to 5.2); P = 0.001], homeostatic model assessment for insulin resistance [- 0.4 (- 1.7 to 1.1) vs. 0.0 (- 0.7 to 1.3); P = 0.002], quantitative insulin sensitivity check index (+ 0.01 ± 0.02 vs. - 0.01 ± 0.01; P = 0.02) and a non-significant change toward improvement in SHBG (+ 11.5 ± 40.2 vs. - 3.2 ± 40.2; P = 0.2). However, there was no significant differences between the two groups in serum levels of fasting plasma glucose, total cholesterol, triglyceride, low density lipoprotein-cholesterol and high density lipoprotein cholesterol (P > 0.05). CONCLUSION: 12-week L-carnitine supplementation in overweight or obese women with PCOS ameliorate insulin resistance, but has no effect on SHBG and lipid profile. Studies with higher dosages and duration of L-carnitine intake are required. The trial was registered on 30 December 2019 at Iranian Registry of Clinical Trials IRCT20191016045131N1. TRIAL REGISTRATION: Registered on 30th December 2019 at Iranian Registry of Clinical Trials (IRCT20191016045131N1).

The effect of Nigella sativa on appetite, anthropometric and body composition indices among overweight and obese women: A crossover, double-blind, placebo-controlled, randomized clinical trial.

OBJECTIVES: Obesity is a global concern which is associated with several complications and disease. DESIGN: Present study is the first crossover, double-blind, placebo-controlled, randomized clinical trial aimed to evaluate the effect of Nigella Sativa (N. sativa) intervention on anthropometric and body composition parameters as well as dietary intake and appetite in a crossover design. METHOD: Forty-five healthy women with obesity or overweight were randomized into two groups of intervention and placebo, and the study conducted in two 8-week periods of intervention separated by a 4-week washout period. Anthropometric and body composition indices and dietary intake were measured. Also, appetite sensation was evaluated via a standard visual analog scale (VAS) questionnaire. Pkcross procedure was performed for statistical analysis using STATA. Cohen's d effect size was estimated for all outcomes to determine the magnitude of the effects. RESULTS: Supplementation with 2000 mg of N. sativa oil found to have a considerable increment in the measures of body mass index (P < 0.001, Cohen's d = 0.5), body weight (P < 0.001, Cohen's d = 0.6) and waist circumference (P = 0.020, Cohen's d = 0.4) with a medium effect size measure, and a significant decrease in body fat mass (P = 0.019, Cohen's d = 0.2), body fat percent (P < 0.001, Cohen's d = 0.2) and visceral fat area (P = 0.011, Cohen's d = 0.2) with a small effect size measure. CONCLUSION: The overall improvements in anthropometric and body composition parameters and a significant decrease in appetite represents the beneficial effects of N. sativa supplements in the treatment of obesity. More studies with different dosages, a larger number of participants, and longer intervention duration are recommended to illustrate the exact effects of N. sativa as a complementary therapy for obesity.

Effect of hypocaloric high-protein, low-carbohydrate diet supplemented with fennel on androgenic and anthropometric indices in overweight and obese women with polycystic ovary syndrome: A randomized placebo-controlled trial.

OBJECTIVE: The aim of this study was to evaluate the effect of hypocaloric high-protein, low-carbohydrate weight loss diet supplemented with fennel on anthropometric and androgen indices in overweight and obese women with polycystic ovary syndrome (PCOS). METHODS: A randomized controlled trial with a factorial design was performed on sixty-four overweight/obese women with PCOS. Participants were randomly allocated to four groups (n = 16 per group) as follows: 1) hypocaloric standardize diet + fennel (2 capsule/day) (HSDF), 2) hypocaloric high-protein diet + fennel (2 capsule/day) (HHPF), 3) hypocaloric standardize diet + placebo (HSDP), and 4) hypocaloric high-protein diet + placebo (HHPP). RESULTS: The mean (SD) age of the participants was 28.54 (6.80) years and body mass index was 32.24 (4.65) kg/m2. At the end of intervention, protein intake was 20.43 % in the groups that received a high-protein diet versus 16.37 % in the standard diet groups (P < 0.001). Combination of hypocaloric high-protein diet and fennel capsule did not significantly affect change in outcomes compared with groups not receiving them. There was a significant interaction between hypocaloric high-protein diet and fennel on weight (P = 0.019). CONCLUSION: A hypocaloric high-protein diet along with fennel supplementation could not provide additional improvements in anthropometric and androgen indices among PCOS women. Further studies are required to more precisely elucidate these findings.

The effect of Nigella sativa supplementation on cardiovascular risk factors in obese and overweight women: a crossover, double-blind, placebo-controlled randomized clinical trial.

PURPOSE: To assess the effect of Nigella sativa (N.S) oil supplements on CVD risk factors in a crossover design for the first time. METHODS: Obese and overweight healthy women were randomized to receive N.S oil (2000 mg/day) and placebo. This intervention period lasted for 8 weeks and separated by a 4-week washout period. An iso-caloric diet was given to every individual throughout the study. Blood pressure, lipid profile, atherogenic indices and liver enzymes were measured. Pkcross procedure was performed for statistical analyses using Stata software. Cohen's d was estimated as effect size for all outcomes to measure the magnitude of the effects. RESULTS: Thirty-nine participants completed the study. Capsules of N.S increased serum high-density lipoprotein cholesterol (Cohen's d = 0.47, P = 0.009), reduced low-density lipoprotein cholesterol (Cohen's d = - 0.33, P = 0.031), reduced TC/HDL-C ratio (as an atherogenic index, Cohen's d = - 0.9, P < 0.001), reduced serum glutamic-oxaloacetic transaminase (Cohen's d = 0- 0.5, P = 0.038) and reduced systolic blood pressure (Cohen's d = - 0.4, P < 0.001). There was no effect on diastolic blood pressure measures (P = 0.96). CONCLUSION: The overall improvements in cardiovascular disease (CVD) risk factors showed beneficial effects of N.S supplements among adults with obesity to prevent possible cardiovascular diseases. More studies with different designs and in other populations are suggested to clarify the exact effects of N.S as a complementary therapy for modulating CVD risk factors in individuals with overweight and obesity. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20180528039884N1, Registered on February 15th, 2019.

The effect of Nigella sativa on the measures of liver and kidney parameters: A systematic review and meta-analysis of randomized-controlled trials.

The aim of this systematic review and dose-response meta-analysis was to determine the effect of Nigella sativa (N.S) supplementation on liver and kidney parameters. We searched PubMed, Scopus, ISI Web of Science, Cochrane central register for controlled trials and Google Scholar from database inception to April 2019 for relevant controlled trials. Mean differences and standard deviations for each outcome were pooled using a random-effects model and a dose-response analysis was performed using a fractional polynomial model. Quality of evidence was evaluated using Cochrane Collaboration Risk of Bias tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Nineteen trials (n = 1295 participants) were included in the meta-analysis. We observed that N.S supplements had significant reducing effects on alkaline-phosphatase (ALP) [9 trials, n = 710 participants, weighted mean difference (WMD)= -10.825; 95 %CI: -19.658, -1.992 U/L; P = 0.016; I2 = 75.7 %; P-heterogeneity = 0.000) and blood urea nitrogen (BUN) (12 trials, n = 821 participants, WMD= -1.016; 95 % CI: -1.760, -0.273 U/L; P = 0.007; I2 = 87.7 %; P-heterogeneity = 0.000) concentrations. Subgroup analysis showed that, an intervention of more than 12 weeks was found to have a reducing effect on aspartate- aminotransferase (AST) measures (2 trials, n = 201 participants, WMD= -11.317; 95 % CI: -15.007, -7.626; P = 0.000; I2 = 0.0 %; P-heterogeneity = 0.977). Creatinine levels increased significantly in studies that considered adjusted analysis based on covariates (3 trials, n = 152 participants, WMD = 0.070; 95 % CI: 0.027, 0.112 U/L; P = 0.001; I2 = 0.0 %; P-heterogeneity = 0.788). A daily dose of 1100-1500 mg of N.S supplements was observed to have a substantial reducing effect on ALP levels (5 trials, n = 340 participants, WMD= -11.323; 95 % CI: -21.418, -1.229 U/L; P = 0.028; I2 = 0.00 %; P-heterogeneity = 0.686), while a dosage of more than 2000 mg per day led to a significant increase in BUN concentrations (2 trials, n = 101 participants, WMD= -1.016; 95 % CI: -1.760, -0.273 U/L; P = 0.007; I2 = 87.7 %; P-heterogeneity = 0.000). Our data suggested that N.S supplementation had significant impacts on liver and kidney parameters leading to a decrease in ALP and BUN levels. Longer duration of intervention and normal daily dosages of N.S supplements led to significant reductions in ALP and AST concentrations, respectively, while higher daily dosages increased BUN levels. Hence, in spite of favorable impacts of N.S supplements on liver and kidney parameters, due to the herbal nature of N.S, more studies with high-quality, large-scale, long-term intervention and precise baseline characteristics are needed to assess the exact effective dose, duration and efficacy of N.S supplementation on kidney and liver parameters.

The effect of intramuscular megadose of vitamin D injections on E-selectin, CRP and biochemical parameters in vitamin D-deficient patients with type-2 diabetes mellitus: A randomized controlled trial.

BACKGROUND AND AIMS: Inflammatory processes has been shown to be associated with the development of type 2 diabetes mellitus (T2DM) in which vitamin D supplementation might exert beneficial outcomes. We examined the effects of vitamin D supplement on inflammatory and cell adhesion molecule in patients with T2DM. METHODS: This study consisted of 50 patients with T2DM who had vitamin D deficiency. Participants were randomized into two groups of 25 in which the intervention group received two intramuscular injections of a 200000-IU vitamin D supplement, one at week 0 and another at week 4. The concentrations of fasting blood glucose (FBG), lipid profiles, liver enzymes, E-selectin, C-reactive protein (CRP), calcium, phosphorus, serum 25-hydroxyvitamin D [25(OH)D] and anthropometric indices were obtained before and after 8 weeks. RESULTS: Vitamin D resulted in significant reductions in CRP(P = 0.01) and gamma glutamyl transferase (GGT) levels(P = 0.03) and significant increases in 25(OH)D concentrations(P = 0.01) in the intervention group compared with the control. Within-group comparisons showed that FBG decreased significantly in the intervention group(P = 0.04). No significant changes were observed regarding within- and between-group comparisons of the other markers. CONCLUSION: Vitamin D had beneficial effects on the levels of CRP, serum 25(OH)D and GGT among vitamin D deficient patients with T2DM. (http://www.irct.ir: IRCT2017100336539N1).

Effect of saffron (Crocus sativus L.) on lipid profile, glycemic indices and antioxidant status among overweight/obese prediabetic individuals: A double-blinded, randomized controlled trial.

OBJECTIVE: To investigate the effects of saffron (Crocus sativus L.) on lipid profile, glycemic and antioxidant status in overweight/obese individuals with prediabetes. METHODS: In this randomized, double-blind, placebo-controlled trial, the prediabetic patients were randomly assigned to receive saffron (15 mg/d) pills or placebo for eight weeks. Serum levels of lipid profile, fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c), blood urea nitrogen (BUN), creatinine, and diphenylpycrylhydrazyl (DPPH) radical scavenging activity were assessed biochemically at baseline and at 8 weeks after treatment. The adverse events, if any, were also recorded. RESULTS: Seventy-five of participants (36 in treatment and 39 in placebo groups) completed the study. Within-group comparisons revealed a significant effect of saffron supplementation on FBS (118.11 ± 3.55 vs. 109.14 ± 6.23), HbA1c (5.85 ± 0.12 vs. 5.70 ± 0.11), and DPPH (11.06 ± 3.24 vs. 13.46 ± 3.33) levels (P < 0.005 for all). In adjusting models, there was a significant reduction in FBS by -7.97 mg/dL, and HbA1c by -0.15% in saffron group compared to placebo. Moreover, saffron intake tended to increase in DPPH radical scavenging activity (2.4% vs. -0.85% in saffron and placebo groups, respectively). However, no significant changes in anthropometric measures, lipid profile, and renal markers were observed after saffron intake compared with placebo. CONCLUSION: Saffron supplementation could improve glycemic and antioxidant indices in overweight/obese individuals with prediabetes, however, no beneficial effect was observed on lipid profile and anthropometric parameters. (IRCT20120913010826N19).

Effects of oral Nigella sativa oil on the expression levels and serum concentrations of adiponectin, PPAR-γ, and TNF-α in overweight and obese women: a study protocol for a crossover-designed, double-blind, placebo-controlled randomized clinical trial.

BACKGROUND: Obesity is a major public health problem in recent decades. The accumulation of excessive fat promotes inflammatory status. Meanwhile, herbal products are marketed for their weight-loss properties, such as Nigella sativa (N. Sativa) which has been used for centuries to treat rheumatoid arthritis, diabetes, and asthma; recently, the anti-obesity characteristics of N. sativa have also been indicated. However, the exact mechanisms and cellular-related pathways are still unclear. Thus, we will aim to assess the effects of oral N. sativa on the gene expression of inflammatory and adipogenesis-related factors, including TNF-α, PPAR-γ, and adiponectin as well as assessing their serum concentrations among obese and overweight individuals. METHODS: Obese and overweight women aged 25-55 years with a body mass index (BMI) of 25-35 kg/m2 will be recruited from the Obesity Clinic in Shahid Sadoughi University of Medical Sciences and will be assessed for eligibility against inclusion criteria. They will be randomly assigned into two groups to receive either two capsules of N. sativa or two capsules of placebo per day for eight weeks (each capsule contains 1000 mg of N. sativa or placebo). There will be a four-week wash-out period and then participants will receive the reverse supplements for another eight weeks. Biochemical assessments and gene expressions (using real-time polymerase chain reaction) will be conducted at the beginning and at the end of every intervention period. DISCUSSION: The present study will investigate the probable cellular pathways for the anti-obesity effects of N. sativa in overweight/obese women. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20180528039884N1 . Registered on 2nd of July, 2018.

The effect of vitamin D supplementation on the androgenic profile in men: A systematic review and meta-analysis of clinical trials.

The aim of this systematic review and meta-analysis was to evaluate the effect of vitamin D supplementation on total testosterone (TT) and sex hormone-binding globulin (SHBG) in men. We searched PubMed, Scopus and Web of Science for randomized, controlled trials of vitamin D supplementation in men ≥18 years old up to September 2018, without language restrictions. Meta-analysis was based on a random effects model. The systematic review was registered as CRD42018094498. We identified 3,402 articles, of which eight studies with 10 effect sizes met the inclusion criteria. Vitamin D daily dose equivalents ranged from 600 to 4,000 per day to 60,000 IU per week; duration was 6 weeks to 36 months. In general, vitamin D supplementation had no significant effect on TT (MD = 0.20, 95% CI: -0.20, 0.60, p = 0.336) and SHBG (MD = 1.56, 95% CI: -0.85, 3.97, p = 0.204). Subgroup analysis conducted with duration of prescription, type (daily or weekly), dosing frequency and baseline vitamin D and TT concentration showed that vitamin D did not significantly affect TT. The present study did not find any evidence to support beneficial effect of vitamin D supplementation on TT and SHBG in men. Thus, further large-scale randomised controlled trials are required to evaluate the effects of vitamin D supplementation on androgen in men.

The clinical effects of purslane (Portulaca oleracea) seeds on metabolic profiles in patients with nonalcoholic fatty liver disease: A randomized controlled clinical trial.

Nonalcoholic fatty liver disease (NAFLD) is the most common form of chronic liver diseases associated with unfavorable metabolic profiles and oxidative stress parameters. This study was designed to determine the effects of purslane seeds consumption with a low-calorie diet on insulin resistance, lipid profile, and oxidative stress indices in patients with NAFLD. This randomized controlled clinical trial was conducted on 54 individuals with NAFLD. Subjects were randomly assigned to consume either 10 g/day of purslane seeds sachet before breakfast and dinner in addition to a low-calorie diet (n = 27) or only the low-calorie diet (n = 27) for 8 weeks. Fasting blood samples were collected at the beginning and end of the study to measure relevant variables. Intake of purslane seeds with the low-calorie diet led to a significant decrease in serum concentrations of fasting blood sugar (FBS; -3.52 ± 10.45 compared with 3.03 ± 9.01 mg/dl, P = 0.017), quantitative insulin sensitivity check index (QUICKI; 0.13 ± 0.27 compared with -0.002 ± 0.016, P = 0.017), total cholesterol (4.33 ± 34.04 compared with 23.48 ± 29.47 mg/dl, P = 0.032), and low-density lipoprotein cholesterol (LDL-C; -4.35 ± 22.65 compared with 11.82 ± 16.08 mg/dl, P = 0.004) after intervention. Compared with the control group, purslane seeds consumption with adherence to a low-calorie diet had beneficial effects on FBS, HOMA-IR, QUICKI, serum total, and LDL-C in patients with NAFLD but did not affect other glycemic, lipid profile, and oxidative stress parameters.

Does pomegranate consumption affect weight and body composition? A systematic review and meta-analysis of randomized controlled clinical trials.

Pomegranate is rich in tannins, polyphenols, flavonoids, and several other types of antioxidant compounds whose role in weight loss has been shown in previous studies. However, the results have been mixed regarding the effects of pomegranate consumption on weight loss. Electronic databases such as PubMed, Scopus, ISI Web of Science, and Google Scholar were systematically searched up to May 2018 for controlled clinical trials assessing the effect of pomegranate consumption on weight loss. A random effects model was used to calculate the weighted mean difference (WMD) and 95% confidence interval (CI) as the difference between the mean for the intervention and control groups. Thirteen randomized controlled trials (including 513 participants) were included in the present meta-analysis. Compared with the control groups, there was no significant reduction in bodyweight, body mass index, waist circumference, and body fat percentage after pomegranate consumption (WMD = -0.23 kg, 95% CI: -0.94, 0.47, P = 0.515; WMD = -0.12 kg/m2 , 95% CI: -0.29, 0.03, P = 0.132; WMD = -0.08 cm, 95% CI: -0.33, 0.17, P = 0.534; WMD = -0.05, 95% CI: -1.66, 1.55, P = 0.947, respectively). According to the results of the present systematic review and meta-analysis, there was no significant effect of pomegranate consumption on weight and body composition indices.

Efficacy of cinnamon in patients with type II diabetes mellitus: A randomized controlled clinical trial.

BACKGROUND & AIMS: Multiple studies have evaluated the hypoglycemic effect of cinnamon in patients with diabetes mellitus (DM) type II, with conflicting results. Differences in Baseline Body Mass Index (BMI) of patients may be able to explain the observed differences in the results. This study was designed to evaluate the effect of cinnamon supplementation on anthropometric, glycemic and lipid outcomes of patients with DM type II based on their baseline BMI. METHODS: The study was designed as a triple-blind placebo-controlled randomized clinical trial, using a parallel design. One hundred and forty patients referred to Diabetes Clinic of Yazd University of Medical Sciences with diagnosis of DM type II were randomly assigned in four groups: cinnamon (BMI ≥ 27, BMI < 27) and Placebo (BMI ≥ 27, BMI < 27). Patients received cinnamon bark powder or placebo in 500 mg capsules twice daily for 3 months. Anthropometric, glycemic and lipid outcomes were measured before and after the intervention. RESULT: Cinnamon supplementation led to improvement of all anthropometric (BMI, body fat, and visceral fat), glycemic (FPG, 2hpp, HbA1C, Fasting Insulin, and Insulin Resistance), and lipids (Cholesterol Total, LDL-c and HDL-c) outcomes (except for triglycerides level). All observed changes (except for Cholesterol Total and LDL-c) were significantly more prominent in patients with higher baseline BMI (BMI ≥ 27). CONCLUSION: Based on the study findings, cinnamon may improve anthropometric parameters, glycemic indices and lipid profile of patients with type II diabetes. These benefits are significantly more prominent in patients with higher baseline BMI (BMI ≥ 27). The trial protocol was registered in Iranian Registry of Clinical Trials database (registration ID: IRCT2017031133015N1).

The Effect of Vitamin D Supplementation on the Androgenic Profile in Patients with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis of Clinical Trials.

It is suggested that vitamin D status is associated with androgenic profile in women with polycystic ovarian syndrome (PCOS). Although several clinical trials are known in this regard, the results were inconsistent. Therefore, this study was aimed to conduct a systematic review and meta-analysis of published clinical trials to elucidate the possible effect of vitamin D supplementation on the androgen levels in adult females with PCOS. PubMed, SCOPUS, and Google Scholar were searched to identify related articles published up to January 2017. Mean ± standard deviation (SD) of changes in serum total testosterone, sex hormone binding globulin (SHBG), and free testosterone were extracted to calculate Hedges' g to be used as effect size for meta-analysis. DerSimonian and Liard random effects model was incorporated to summarize the effects. Six clinical trials with 183 participants aged 18-41 years with follow-up period between 3-24 weeks were included. Our analysis revealed that vitamin D supplementation significantly reduces total testosterone (Hedges' g=-0.32, 95% CI: -0.55 to -0.10; p=0.005); this effect remained significant in single group trials after subgroup analysis. Vitamin D supplementation did not affect serum free testosterone (Hedges' g=-0.21, 95% CI: -0.44 to 0.079; p=0.08) or SHBG levels (Hedges' g=0, 95% CI, 0.22-0.22; p=0.98). The present systematic review and meta-analysis revealed that vitamin D supplementation might significantly affect serum total testosterone while it is not effective in improving other markers of androgenic profile. Future double-blind, placebo-controlled clinical trials are highly recommended.

Effect of Ziziphus jujube Fruit Infusion on Lipid Profiles, Glycaemic Index and Antioxidant Status in Type 2 Diabetic Patients: A Randomized Controlled Clinical Trial.

This study was designed to assess the effects of Ziziphus jujube fruit (ZJF) infusion on lipid profiles, glycaemic control and antioxidant status in patients with type 2 diabetes mellitus (T2DM). In this randomized controlled clinical trial, 116 participants with T2DM (older than 30 years) were assigned to consume a balanced diet or diet plus ZJF infusion (10 g/100 mL boiling water) three times/day before main meals for 12 weeks. Diet was designed to be energy restricted (500 kcal/day deficit from estimated energy requirements), and macronutrient content was similar in both groups (55% carbohydrate, 15% protein and 30% fat). The consumption of ZJF infusion compared with the control group was associated with significant improvement in glycosylated haemoglobin (-0.68 ± 0.65 vs. -0.44 ± 0.55%; p = 0.03), total cholesterol (-24.29 ± 28.89 vs. -11.21 ± 29.98 mg/dL; p = 0.02), triglycerides (-43.3 ± 39.26 vs. -27.16 ± 46.84 mg/dL; p = 0.05), low-density lipoprotein cholesterol (-19.85 ± 27.62 vs. -6.55 ± 27.82 mg/dL; p = 0.01), low-density lipoprotein cholesterol/high-density lipoprotein cholesterol (-0.56 ± 0.80 vs. -0.2 ± 0.72; p = 0.01) and total cholesterol to high-density lipoprotein cholesterol ratios (-0.73 ± 0.94 vs. -0.35 ± 0.77; p = 0.02). ZJF had beneficial effects on glycosylated haemoglobin and lipid profile in T2DM patients. Further research is needed to identify the mechanism of ZJF action on glucose and lipid metabolism. Copyright © 2017 John Wiley & Sons, Ltd.

Effect of Ginger Supplementation on Proinflammatory Cytokines in Older Patients with Osteoarthritis: Outcomes of a Randomized Controlled Clinical Trial.

There is limited evidence that ginger powder consumption can relieve pain and inflammation due to specific anti-inflammatory phytochemical constitutents. This study investigates the effect of ginger supplementation on proinflammatory factors in participants (n = 120) of a randomized double-blind placebo-controlled 3-month clinical trial investigating knee osteoarthritis. Patients were randomly assigned to one of two groups: the ginger group (GG) or the placebo group (PG). Administered daily for 3 months, participants in the GG intervention received capsules containing 500 mg of ginger powder, while PG participants received capsules filled with 500 mg starch. Serum samples collected at baseline and 3 months were analyzed for serum levels of tumor necrosis factor-α (TNF-α) and interleukin-1ß (IL-1ß). At baseline, proinflammatory cytokine concentrations did not differ by group. However, at 3 months, both cytokines decreased in the GG relative to the PG. The results of this study indicate that ginger supplementation may have a promising benefits for knee osteoarthritis and may, therefore, may warrant further study.

Effect of ginger powder supplementation on nitric oxide and C-reactive protein in elderly knee osteoarthritis patients: A 12-week double-blind randomized placebo-controlled clinical trial.

There is limited evidence that ginger ( sheng jiang) powder consumption can relieve pain and inflammation because of its special phytochemical properties. This study is aimed at investigating the effect of ginger powder supplementation on some inflammatory markers in patients suffering from knee osteoarthritis. This is a double-blind randomized placebo-controlled clinical trial with a follow-up period of 3 months that was conducted on 120 outpatients with moderately painful knee osteoarthritis. Patients were randomly divided up into two groups: ginger group (GG) or placebo group (PG). Both groups received two identical capsules on a daily basis for 3 months. Each ginger capsule contained 500 mg of ginger powder; the placebo capsules had 500 mg of starch in them. Serum samples were collected prior to and after the intervention and were stored at -70 °C until the end of the study. Serum concentration of nitric oxide (NO) and hs-C reactive protein (hs-CRP) were measured using enzyme-linked immunosorbent assay kits. There was no significant difference between the two groups in terms of inflammatory markers (i.e., NO and hs-CRP) prior to the intervention. However, after 3 months of supplementation, serum concentration of NO and hs-CRP decreased in the GG. After 12 weeks, the concentration of these markers declined more in the GG than in the PG. Ginger powder supplementation at a dose of 1 g/d can reduce inflammatory markers in patients with knee osteoarthritis, and it thus can be recommended as a suitable supplement for these patients.