Effect of Low-Fat Diet on Depression Score in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials.

CONTEXT: Current evidence on the effect of a low-fat (LF) diet on depression scores has been inconsistent. OBJECTIVE: To explore the effect of an LF diet on depression scores of adults by systematic review and meta-analysis of randomized controlled trials (RCTs). DATA SOURCES: The PubMed, ISI Web of Science, Scopus, and CENTRAL databases were searched from inception to June 7, 2023, to identify trials investigating the effect of an LF diet (fat intake ≤30% of energy intake) on the depression score. DATA EXTRACTION: Random-effects meta-analyses were used to estimate pooled summary effects of an LF diet on the depression score (as Hedges g). DATA ANALYSIS: Finding from 10 trials with 50 846 participants indicated no significant change in depression score following LF diets in comparison with usual diet (Hedges g = -0.11; 95% CI, -0.25 to 0.03; P = 0.12; I2 = 70.7% [for I2, 95% CI, 44%, 85%]). However, a significant improvement was observed in both usual diet and LF diets when the content of protein was 15-20% of calorie intake (LF, normal protein diet: n = 5, Hedges g = -0.21, 95% CI, -0.24 to -0.01, P = 0.04, I2 = 0%; usual, normal protein diet: n = 3, Hedges g = -0.28, 95% CI, -0.51 to -0.05, P = 0.01, I2 = 0%). Sensitivity analysis also found the depression score improved following LF diet intervention in participants without baseline depression. CONCLUSION: This study revealed that LF diet may have small beneficial effect on depression score in the studies enrolled mentally healthy participants. Moreover, achieving to adequate dietary protein is likely to be a better intervention than manipulating dietary fat to improve depression scores. However, it is not clear whether this effect will last in the long term. Conducting more studies may change the results due to the low-certainty of evidence. SYSTEMATIC REVIEW REGISTRATION: CRD42023420978 (https://www.crd.york.ac.uk/PROSPERO).

A systematic review of dysregulated microRNAs in Hashimoto's thyroiditis.

BACKGROUND: Plenty of evidence suggests that dysregulated microRNAs are linked to developing autoimmune thyroid diseases. In this study, we aimed to identify commonly linked dysregulated microRNAs in Hashimoto's thyroiditis(HT) and explore microRNA-targeted genes and the involved pathways. METHODS: Embase, PubMed, Web of Science, and Scopus databases were searched using the MeSH terms and free text terms, which yielded 11879 articles published up to July 2023. Two-step screening(first for titles and second for abstracts) was completed according to inclusion and exclusion criteria. The search strategy was formulated using the PEO format(Population, Exposure, and Outcome) for observational studies. The corresponding target genes and relevant signaling pathways were also identified using web servers of Diana Tools/its mirPath v.3 software, miRNA Enrichment Analysis, Mirpath DB2, miRPathDB 2.0, and miRmap. RESULTS: Review inclusion criteria were met by 16 studies. Thirty-three microRNAs were identified as differentially expressed in HT patients compared to a healthy control after qRT-PCR or RNA sequencing confirmation. Only three miR-146a, miR-142, and miR-301 showed significant results in more than two studies comparing HT cases with healthy controls. CONCLUSION: Three key microRNAs in HT were identified by systematic review; the corresponding target genes and signaling pathways involved in the target genes were also identified. These microRNAs regulate the immune response and inflammation and may favor the development and progression of HT. These data may be beneficial to make a step forward to understand the exact etiology of HT and use of these MicroRNAs as possible diagnostic and prognostic biomarkers and as target therapy.

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).

The Mediterranean, DASH, and MIND diets and the incident of hypertension over a median follow-up of 7.4 years in the Tehran Lipid and Glucose Study.

BACKGROUND: Despite the favorable effects of well-known dietary patterns in the treatment of hypertension (HTN), such as the Mediterranean (MED) and Dietary Approach to Stop Hypertension (DASH) diets, it is uncertain if adherence to these diets can reduce the risk of HTN, especially in non-Mediterranean populations. Moreover, none of the previous studies evaluated the association between the MED-DASH Intervention for Neurodegenerative Delay (MIND) diet adherence and the incidence of HTN. Therefore, we aimed to assess the association of adherence to these diets with the development of HTN in adults. METHODS: This prospective study included 2706 adults free of HTN who were selected from the Tehran Lipid and Glucose Study. The MED, DASH, and MIND diet scores were computed at baseline using dietary information collected with the food frequency questionnaire. Associations between the dietary indices and risk of HTN over a median follow-up of 7.4 years were examined using Cox proportional hazards regression analysis. RESULTS: The baseline mean age of participants was 37.9 ± 12.5 years (age range: 20-79 years), and 52.4% were women. During the 18262 person-years follow-up, 599 incidents of HTN were identified. There was no significant relationship between the dietary scores and the risk of HTN, either as continuous or categorical variables, even after excluding individuals with early/late HTN diagnosis, prehypertension, diabetes, or chronic kidney disease at baseline. A significant interaction was found between body mass index (BMI) and DASH (P-interaction < 0.001). Stratified analyses based on baseline BMI status revealed an inverse association between DASH and HTN risk in individuals with normal-weight (HR = 0.84, 95% CI = 0.71-0.98, P = 0.031), although this association did not reach statistical significance across the tertiles of DASH. CONCLUSIONS: In this study, MED, DASH, and MIND showed no significant association with the occurrence of HTN in adults. Further prospective studies on diverse populations are required to assess whether adherence to the MED, DASH, and MIND diets is an effective strategy for reducing the occurrence HTN.

The effects of olive leaf extract on cardiovascular risk factors in the general adult population: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The aim of this systematic review and meta-analysis was to determine the effect of olive leaf extract (OLE) supplementation on cardiovascular-related variables, including lipid, glycemic, inflammatory, liver and renal-related factors, as well as blood pressure. METHODS: PubMed, ISI Web of Science, Scopus, and Cochrane library were searched, up to October 2021, for relevant controlled trials. Mean differences and standard deviations were pooled for all outcomes, using a random-effects model. The methodological quality, as well as quality of evidence were assessed using standard tools. RESULTS: Twelve studies (n = 819 participants) were included in our analyses. Overall analyses showed that OLE supplementation significantly decreased triglyceride (TG) levels (WMD = - 9.51 mg/dl, 95% CI - 17.83, - 1.18; P = 0.025; I2 = 68.7%; P-heterogeneity = 0.004), and systolic blood pressure (SBP) (WMD = - 3.86 mmHg, 95% CI - 6.44, - 1.28 mmHg; P = 0.003; I2 = 19.9%; P-heterogeneity = 0.28). Subgroup analyses also revealed a significant improvement in SBP (- 4.81 mmHg) and diastolic blood pressure (- 2.45 mmHg), TG (- 14.42 mg/dl), total cholesterol (TC) (- 9.14 mg/dl), and low-density lipoprotein-C (LDL-C) (- 4.6 mg/dl) measurements, in patients with hypertension. Significant reductions were also observed in TC (- 6.69 mg/dl), TG (- 9.21 mg/dl), and SBP (- 7.05 mmHg) in normal-weight individuals. However, no meaningful changes were seen in glucose hemostasis, liver and kidney, or inflammatory markers. CONCLUSION: The present study revealed that supplementation with OLE yielded beneficial effects for blood pressure and lipid profile in adults, especially in patients with hypertension. As the quality of evidence for glucose hemostasis variables, liver, kidney, and inflammatory markers, were low-to-very low, higher quality RCTs may impact the overarching results. This study was registered at PROSPERO with the code CRD42022302395.

The effect of Nigella sativa on TAC and MDA in obese and overweight women: secondary analysis of a crossover, double blind, randomized clinical trial.

Purpose: Since obesity is a risk factor for various diseases and is associated with increased oxidative stress conditions, some herbs are considered to be effective in reducing obesity and its complications. Methods: This secondary analysis investigates the effect of Nigella sativa (N.S) oil supplement on total antioxidant capacity (TAC) and malondialdehyde (MDA) levels in obese/overweight women. Obese and overweight healthy women were randomized to receive 2,000 mg/d of N.S supplement and placebo. The intervention periods lasted 8 weeks and were separated by a 4-week washout period. Also, each participant was given an iso-calorie diet. Baseline characteristics and TAC and MDA levels were measured. Pkcross analysis was performed for statistical analysis using Stata software. Also, Cohen's d was estimated as effect size for all results to assess the magnitude of the effects. Results: 39 women completed the study. N.S oil supplementation at a dose of 2000 mg/d significantly increased serum TAC (P effect = 0.017, Cohen's d = 1.81) and reduced serum MDA (P effect < 0/001, Cohen's d = - 0.32). Conclusion: Based on our findings taking N.S supplementation for 8 weeks can improve antioxidant conditions in obese and overweight adults. However, more studies with a larger population and the presence of both genders need to be done to confirm the results.Registration number: IRCT20180430039475N1.

The effect of synbiotic supplementation on atherogenic indices, hs-CRP, and malondialdehyde, as major CVD-related parameters, in women with gestational diabetes mellitus: a secondary data-analysis of a randomized double-blind, placebo-controlled study.

BACKGROUND: Women with GDM have a higher risk of future cardiovascular diseases (CVD). Meanwhile, synbiotics have been demonstrated to have favorable impacts on atherogenic indices, and inflammatory and oxidative stress indicators, all of which are known to be CVD-predictive factors. The aim of this randomized controlled trial was to evaluate the effects of synbiotic supplementation on the atherogenic indices of plasma, high-sensitivity C-reactive protein (hs-CRP), and plasma malondialdehyde (MDA) in women with GDM. METHODS: Eligible pregnant women with GDM were randomized into two groups to receive a daily synbiotic capsule [500 mg of L.acidophilus(5 × 1010 CFU/g), L.plantarum(1.5 × 1010 CFU/g), L.fermentum(7 × 109 CFU/g), L.Gasseri(2 × 1010 CFU/g) and 38.5 mg of fructo-oligo-saccharides], or placebo, for 6 weeks. The ratios of TC/HDL-C, LDL/HDL-C, and logTG/HDL-C were calculated as the atherogenic indices. Serum hs-CRP and MDA concentrations were quantified before and after the intervention. Cohen's d(d) was used to calculate the magnitude of the effect. RESULTS: Ninety participants completed the study. There was no significant difference in dietary antioxidant and mineral intakes between the two groups. Compared with placebo, synbiotic supplementation resulted in a significant decrease in logTG/HDL-C ratio with a medium-low effect size (mean difference = -0.11; 95% CI -0.21, 0; P values for the placebo and the intervention groups were 0.02, and 0.042, respectively; P between groups = 0.003; d = 0.25). No significant changes were observed in other parameters. CONCLUSIONS: Overall, 6 weeks of synbiotic supplementation in women with GDM resulted in a significant improvement in logTG/HDL-C, suggesting that synbiotics may have a beneficial role in reducing the risk of future CVDs associated with GDM. Nevertheless, more studies are needed to confirm the veracity of these results. Trial Registration IRCT201511183140N16 (December 29th, 2015).

Effectiveness of logotherapy and nutrition counseling on psychological status, quality of life, and dietary intake among breast cancer survivors with depressive disorder: a randomized clinical trial.

Breast cancer (BC) can negatively influence multiple facets of survivors' lives including mental health, quality of life (QoL), and dietary behavior. Logotherapy as a psycho-education program may help breast cancer survivors (BCSs) discover their meaning of life throughout distressful events. The present study aimed to determine the effects of logotherapy along with nutrition counseling on psychological status, QoL, and dietary intake among BCSs who were diagnosed with depression.This randomized clinical trial was conducted on 90 BCSs who scored ≥ 14 on Beck's depression test. Participants were randomly assigned into two groups to receive nutrition counseling plus logotherapy (n = 46) or nutrition counseling alone (n = 44) for 8 weeks. Primary outcomes (depression, anxiety, and QoL) and secondary outcomes (anthropometric indices, dietary intake, and eating disorder status) were measured at baseline and after 8 weeks.All dimensions of QoL, anthropometric measurements, and the compulsive eating scale improved significantly in both groups after 8 weeks. A combination of nutrition counseling and logotherapy resulted in a significant reduction in anxiety (P < 0.001) and depression (P < 0.001) scores compared with the nutrition counseling alone. In addition, participants who received logotherapy plus nutrition counseling significantly consumed less energy, carbohydrate, and fat intake after 8 weeks compared with the control group (P < 0.001).It can be concluded that logotherapy along with nutrition education would be an important step in improving anxiety, depression, and QoL of patients with BC who had depressive symptoms.Trial registration number: (IR.ACECR.IBCRC.REC.1396.17).

Effects of Nigella sativa supplementation on blood concentration and mRNA expression of TNF-α, PPAR-γ and adiponectin, as major adipogenesis-related markers, in obese and overweight women: a crossover, randomised-controlled trial.

Adipocyte expansion through adipogenesis can offset the adverse metabolic effects of obesity. Nigella sativa (NS) (black seed) oil is shown to have therapeutic features in the management of obesity. NS oil might have beneficial changes in obese populations through mediating serum levels of adipogenesis-related parameters and relative transcriptional gene-diet interactions (nutrigenomics), though no previous studies assessed this mechanism in overweight/obese participants. This study assessed the effects of NS oil supplements on blood concentration and mRNA expression levels of TNF-α, PPAR-γ and serum adiponectin and expression of AdipoR1, as major adipogenesis and obesity-related parameters, in overweight/obese women using a cross-over design. Eligible women were randomised to receive either NS oil supplements (2000 mg/d) or placebo. Two periods of interventions (8 weeks in each) were cross-changed by a 4-week washout period. An individualised diet plan without calorie deficits was given to participants to match their energy/macronutrient intakes. The Pkcross procedure and intention-to-treat analysis were performed using Stata. Cohen's d(d) was estimated to measure the magnitude of the effects. Forty-six participants were included. NS oil capsules reduced transcription levels ((d = -2·31), P < 0·001) and blood concentrations of TNF-α ((d = -0·29), P < 0·001). AdipoR1 expression (d = 2·24, P < 0·001) and serum adiponectin (d = 0·88, P < 0·001) showed a significant augmentation with a medium-high effect size, as did gene expression (d = 0·69, P < 0·001) and serum levels of PPAR-γ (d = 0·97, P < 0·001). There was a moderate but significant decrease in body weight (d = 0·6, P < 0·001). The present beneficial findings would provide strong information for future nutrigenomics/clinical trial studies assessing the role of NS in the management of obesity and other comorbidities.

Effect of Dietary-Based Lifestyle Modification Approaches on Anthropometric Indices and Dietary Intake Parameters in Women with Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

This systematic review and meta-analysis aimed to investigate the effect of dietary-based lifestyle modification interventions ("diet," or "diet + exercise," or "diet + exercise + behavioral" intervention) on the measures of anthropometric and dietary intake parameters in women with breas cancer (BC). Databases were searched until June 2021. Inclusion criteria were randomized controlled trials that enrolled only women with BC. Studies that used exercise or behavioral interventions alone were not included. Mean ± SD changes were extracted for each outcome, and pooled using a random-effects model; 7315 studies were identified. Fifty-one studies (n = 7743) were included. The median ± SD duration of treatment was 24 ± 16.65 wk. Dietary-based interventions significantly reduced body weight [45 studies (n = 7239), weighted mean difference (WMD) (95% CI): -2.6 (-3.2, -2.1) kg], BMI [31 studies (n = 5384); WMD (95% CI): -1.0 (-1.3, -0.7) kg/m2], lean body mass [15 studies (n = 1194); WMD (95% CI): -0.6(-0.7, -0.4) kg], fat mass [11 studies (n = 913); WMD (95% CI): -2.6 (-3.3, -1.8) kg], fat percentage [17 studies (n = 897); WMD (95% CI): -1.5 (-1.9, -1.3)%], hip circumference [9 studies (n = 489); WMD (95% CI): -2.43 (-3.34, -1.54) cm], and waist circumference [7 studies (n = 309); WMD (95% CI): 0.02 (-0.03, -0.005) cm]. Significant reductions in energy intakes [20 studies (n = 4608), WMD (95% CI): -162 (-220, 104) kcal/d] and fat intakes [7 studies (n = 4316), WMD (95% CI): -7.5 (-7.8, -7.2)% of energy/d], and an increase in fiber intakes [11 studies (n = 4241), WMD (95% CI): 2.4 (0.7, 4.1) g/d] were observed. No significant changes were seen in protein, carbohydrate, and fruit and vegetable intakes. Subgroup analyses showed that changes in anthropometric and dietary intake indices were significant in studies that enrolled patients with both obesity and normal weight, studies that used diet therapy in combination with exercise and behavioral therapy, and studies that started the intervention during the treatment period. Overall, a multimodal dietary-based lifestyle intervention had significant effects on anthropometric and dietary intake parameters in women with BC, specifically when started as early as the diagnosis. This meta-analysis was registered at PROSPERO as CRD42021291488.

Effects of probiotic supplementation on major cardiovascular-related parameters in patients with type-2 diabetes mellitus: a secondary-data analysis of a randomized double-blind controlled trial.

BACKGROUND: Patients with type-2 diabetes mellitus (T2DM), have a higher risk of future cardiovascular diseases (CVD). Meanwhile, probiotics are shown to positively impact CVD-related parameters. This randomized controlled trial sought to evaluate the effects of probiotic supplementation on fundamental CVD-related parameters including atherogenic index of plasma (AIPs), blood pressure, the Framingham risk score, and antioxidant markers in patients with T2DM. METHODS: Eligible participants were randomly assigned to receive 2 capsules/day of probiotics [each containing 500 mg of L.acidophilus(5 × 1010 CFU/g), L.plantarum(1.5 × 1010 CFU/g), L.fermentum(7 × 109 CFU/g), L.Gasseri(2 × 1010 CFU/g) and 38.5 mg of fructo-oligo-saccharides], or placebo for 6 weeks. Systolic and diastolic blood pressures (SBP and DBP, respectively), mean arterial blood pressure (MAP), atherogenic indices (the ratios of TC/HDL-C, LDL-C/HDL-C, and logTG/HDL-C), the 10-year Framingham CVD risk score, as well as total anti-oxidant capacity (TAC), paraoxonase (PON) and total oxidant status (TOS) were evaluated before and after the study. Final analyses were adjusted based on baseline parameters, and potential covariates including age, sex, PUFA and sodium intakes. RESULTS: Sixty participants completed the study. Compared with placebo, probiotic supplementation resulted in a significant decrease in SBP[-9.24 mmHg(- 14.5, - 3.9)], DBP[- 3.71 mmHg(- 6.59, - 0.83)], MAP[- 5.55 mmHg(- 8.8, - 2.31)], the Framingham risk categories [medium-low(1.5) vs. 2 (medium)] and logTG/HDL-C ratio [- 0.08 (- 0.14, 0)] (All P < 0.05) at the end of the study. No significant changes were observed in the antioxidant markers. CONCLUSION: Overall, probiotic supplementation for 6 weeks led to a significant improvement in major CVD-related parameters in populations with T2DM, suggesting the possible beneficial role of probiotics in lowering the risk of future CVDs associated with diabetes. Nevertheless, more studies are needed to confirm the veracity of these results. TRIAL REGISTRATION: IRCT2013100714925N1 (registered on November, 9th, 2013).

The Effect of Vitamin D Supplementation on Treatment-Induced Pain in Cancer Patients: A Systematic Review.

OBJECTIVES: Despite the widespread use of complementary and alternative medicine by patients and physicians alike, there is no accurate evidence regarding the effects of vitamin D supplementation on treatment-induced pain in cancer patients. Thus, the aim of this systematic review of randomized controlled trials (RCTs) was to evaluate the impact of vitamin D administration on therapy-related pain in subjects diagnosed with malignant disorders. REVIEW ANALYSIS METHODS: We searched the Web of Science, Scopus, PubMed/Medline, Embase, and Google Scholar databases up to October 2020 to identify published RCTs that investigated the use of vitamin D in the management of treatment-induced pain in individuals with cancer. RESULTS: Nine RCTs were detected. The median duration of the intervention was of 24 weeks (range 12-52 weeks) and dose of vitamin D employed was 2000-50000 IU of vitamin D3 weekly orally each day. Six RCTs reported a significant reduction in pain, whereas three did not detect a notable decrease of this variable. Of the six studies that reported an alleviation of pain, an RCT which recruited 60 participants and lasted for 24 weeks consisted of supplementation with high doses of vitamin D2 weekly for 8 weeks in women receiving anastrozole as adjuvant therapy, then supplementation with vitamin D2 monthly for 4 months, effectively alleviated the aromatase inhibitor-associated musculoskeletal syndrome (AIMSS). The results of the same RCT also suggested a beneficial effect of vitamin D on musculoskeletal pain. CONCLUSIONS: Our results suggest that the supplementation with high doses of vitamin D in cancer patients with low serum levels of vitamin D, can be effective in reducing treatment-related pain.

The effect of omega-3 fatty acid supplementation on seizure frequency in individuals with epilepsy: a systematic review and meta-analysis.

BACKGROUND: Although there is ample evidence for the effect of omega-3 supplementation on seizure frequency in individuals with epilepsy, the results are inconsistent. Therefore, we conducted this systematic review and meta-analysis to elucidate the potential effect of omega-3 supplementation in the adult and pediatric population. METHODS: Clinical trials articles were searched in electronic databases (Web of Science, Scopus, PubMed/Medline, Embase, and Google Scholar database up to October 2020). No language limitation was imposed in the literature search. Moreover, gray literature search was done via searching the references of identified review papers to find more potentially relevant articles. RESULTS: In order, the duration of the intervention and dosage of omega-3 fatty acid supplement of the included studies ranged from 12 to 42 weeks and 1000-2880 mg/day. Pooled results from the random-effects model indicated that seizure frequency following supplementation of omega-3 fatty acid decreased significantly (WMD: -6.15, 95% CI: -7.78, -4.53, P < 0.001). Furthermore, the results of the subgroup analysis revealed that seizure frequency was more alleviated in studies that used a daily dose of 1500 mg or less of omega-3 fatty acids as well as studies that had an intervention duration of more than 16 weeks. More importantly, our findings also showed that the effect of omega-3 intervention was greater in adults than in children with epilepsy. CONCLUSION: The current meta-analysis on available trials suggested that omega-3 supplementation resulted in beneficial effects on seizure frequency in adult and children with epilepsy.

Effects of synbiotic supplementation on serum adiponectin and inflammation status of overweight and obese breast cancer survivors: a randomized, triple-blind, placebo-controlled trial.

PURPOSE: Adipokines and inflammatory factors can affect breast cancer (BC) prognosis and recurrence among breast cancer survivors (BCSs). This study was to evaluate the effects of synbiotic supplementation along with a low-calorie diet on some recurrence-related factors such as adiponectin, tumor necrosis factor-alpha (TNF-α), and high-sensitivity C-reactive protein (hs-CRP) among obese and overweight BCSs. METHODS: We performed a randomized, triple-blind, placebo-controlled clinical trial among 76 overweight or obese postmenopausal women with a history of hormone-receptor-positive BC. Participants were randomly divided into 2 groups to intake either 109 CFU/day synbiotic supplement or placebo (n = 38 each group) for 8 weeks. All participants were given a low-calorie diet program. The primary outcome was serum concentration of adiponectin which was measured at baseline and after 8 weeks. RESULTS: Compared with the placebo, synbiotic intake significantly increased adiponectin (+ 13.58 (10.08, 18.17) vs. - 0.42 (- 2.90, 1.98) µg/ml; P < 0.001). In addition, synbiotic supplementation resulted in significant reduction in TNF-α levels (- 17.09 (- 32.05, - 13.60) vs. 0.20 (- 3.97, 2.00) ng/L; P < 0.001) and hs-CRP levels (- 1.14 (- 1.90, - 0.88 vs. - 0.06 (- 0.38, 0.15) mg/L; P < 0.001) compared with the placebo. CONCLUSIONS: In conclusion, 8-week synbiotic consumption by overweight and obese postmenopausal BCSs had beneficial effects on adiponectin, TNF-α, and hs-CRP. TRIAL REGISTRATION: IRCT, IRCT20091114002709N49. Registered 18 May 2018, http://www.irct.ir : IRCT20091114002709N49.

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.

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 synbiotic on glycemic profile and sex hormones in overweight and obese breast cancer survivors following a weight-loss diet: A randomized, triple-blind, controlled trial.

BACKGROUND: The investigation was designed to assess the effects of synbiotic supplementation on glycemic profile, insulin-like growth factor-1 (IGF-1) and sex hormones in overweight and obese postmenopausal breast cancer survivors (BCSs) who had hormone-receptor-positive breast cancer. METHODS: This randomized, triple-blind, placebo-controlled trial was conducted on 76 overweight and obese BCSs aged 57.43 (5.82) years. All participants were given a specified low calorie diet and were randomly assigned into two groups to intake 109 CFU/day of synbiotic supplement (n = 38) or placebo (n = 38) for 8 weeks. Body composition, physical activity, glycemic profile, IGF-1, estradiol, testosterone and dehydroepiandrosterone sulfate (DHEA-S) were measured at baseline and after 8 weeks. RESULTS: A significant reduction in serum insulin (median change (Q1, Q3) from baseline of -1.05 (-2.36, 0.32) µIU/mL; P = 0.006) and insulin resistance (HOMA-IR) (mean change (SD) from baseline of -4.0 (0.9); P = 0.007) were seen over the 8 weeks in the synbiotic group. However, no significant changes were observed in serum insulin, fasting plasma glucose, HbA1c, HOMA-IR, IGF-1, estradiol, testosterone, DHEA-S and sex hormone binding globulin between-groups at the end of the intervention. CONCLUSIONS: Overall, as the 8-week synbiotic consumption compared with placebo had insignificant-reducing effects on glycemic profile, IGF-1 and sex hormones among overweight and obese postmenopausal BCSs, synbiotics may exert considerable beneficial consequences, which need to be further assessed in future clinical trials. TRIAL REGISTRATION: IRCT, IRCT2015090223861N1. Registered 02 February 2017, http://www.irct.ir: IRCT2015090223861N1.

Effects of Vitamin D Supplementation on Omentin-1 and Spexin Levels, Inflammatory Parameters, Lipid Profile, and Anthropometric Indices in Obese and Overweight Adults with Vitamin D Deficiency under Low-Calorie Diet: A Randomized Placebo Controlled Trial.

BACKGROUND AND AIMS: Improved vitamin D levels can have a favorable effect on some metabolic variables. The objective of the current study was to determine the effects of vitamin D supplementation during a weight-loss intervention on the levels of omentin-1, spexin, lipid profiles, and inflammatory factors in obese and overweight participants. METHODS AND MATERIALS: In this double-blind placebo-controlled randomized clinical trial, 70 overweight and obese participants with vitamin D deficiency (25(OH)D ≤ 20 nmol/L) were assigned into the intervention (a daily dose of 2,000 IU vitamin D + low-calorie diet) and placebo (placebo + low-calorie diet) groups for 8 weeks. Anthropometric parameters, serum levels of 25-hydroxy vitamin D (25(OH)D), lipid profiles, omentin-1 and spexin levels, high-sensitivity C-reactive protein (hs-CRP), and soluble intercellular adhesion molecule-1 (sICAM-1) concentrations were assessed before and after the intervention. RESULTS: Vitamin D supplementation after the intervention led to a significant decrease in triglycerides (TG) (P = 0.02), very-low-density lipoprotein-cholesterol (VLDL-C) (P = 0.02), and hs-CRP (P = 0.03) concentrations and a significant increase in the serum vitamin D level (P < 0.001). Furthermore, after adjusting for baseline values, age, and baseline BMI, the levels of serum high-density lipoprotein-cholesterol (HDL-C) (P = 0.01) increased significantly, and a significant reduction was observed in the concentration of sICAM-1 (P = 0.01) in the intervention group. However, we did not find any significant difference in serum omentin-1 and spexin concentrations between the groups after intervention. CONCLUSIONS: Vitamin D supplementation along with a low-calorie diet (LCD) program for 8 weeks significantly decreased the inflammatory markers in obese individuals, while it did not alter serum omentin-1 and spexin concentrations.

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.

Fine-tuning of routine combined first- trimester screening: The ratio of serum-free- beta-human chorionic gonadotropin (fß-hCG) to pregnancy-associated plasma protein-A (PAPP-A) could improve performance of Down syndrome screening program, a retrospective cohort study in Iran.

OBJECTIVES: To evaluate the performance of the current national screening policy for Down syndrome (DS) in Iran and suggest a more efficient protocol with a wealth of a large series of first-trimester screening (FTS) data obtained from Nilou medical laboratory. To fulfill this aim, detection rate (DR), positive screening rate (PSR), false negative rate (FNR) and odds of being affected given a positive results (OAPR) were calculated at different cutoff risk. In the latest update of DS screening program in Iran, there is no place for intermediate group to be further investigated. Next, we proposed a novel parameter namely the ratio of fß-hCG multiple of the median (MoM) value to PAPP-A MoM value to delicately categorize FTS results in a way that reduce FNR without imposing unnecessary anxious and extra money on most families. METHODS: The present investigation was conducted retrospectively on 197,210 pregnancies undergoing FTS for aneuploidies in Nilou medical laboratory, Tehran, Iran, from March 2015 to February 2016. RESULTS: Intermediate risk group is important as 23 out of 45 FN fell in the range 1:250 to 1:1100. By applying the proposed index, the ratio of fß-hCG MoM to PAPP-A MoM and subsequent decision about NIPT, 8 out of 23 FN cases in intermediate group could be detected. CONCLUSION: Compared with the current policy, our novel proposed approach had better performance and could be applied by the Iran National Health Service to improve the screening program guideline.