Effects of boron citrate supplementation on cardiometabolic factors, inflammatory biomarkers and anthropometric measures in obese patients: study protocol for a randomised, double-blind clinical trial.

INTRODUCTION: Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. The efficacy and safety of boron citrate (BC), a novel therapeutic approach, in patients with obesity are not known. The current trial will take place to determine the effects of BC supplementation on cardiometabolic factors, inflammatory biomarkers, anthropometric measures and body composition in obese patients. METHODS AND ANALYSIS: This double-blind, placebo-controlled, randomised clinical trial will involve 60 eligible obese participants aged 18-60 years. Participants will randomly be allocated to receive either BC capsules (containing 10 mg of boron) in the intervention group or placebo capsules (containing 10 mg of maltodextrin) in the placebo group for 12 weeks. Moreover, physical activity and dietary recommendations will be provided for both groups. To assess the dietary intakes of participants, a 3-day food record (2 days of the week and 1 day of the weekend) will be filled. Cardiometabolic factors, inflammatory biomarkers including tumour necrosis factor α, C reactive protein, interleukin-6 and interleukin-10 levels, anthropometric measures and body composition will be assessed at the baseline and end of the intervention. The findings of this study will provide evidence for the effectiveness of BC in the management of obesity. ETHICS AND DISSEMINATION: There are so far no reported adverse effects associated with the use of boron. This trial was approved by the Ethics Committee of Tabriz University of Medical Sciences (approval number: IR.TBZMED.REC.1401.350). Positive as well as negative findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: IRCT20220806055624N1.

Effects of oleoylethanolamide supplementation on the expression of lipid metabolism-related genes and serum NRG4 levels in patients with non-alcoholic fatty liver disease: A randomized controlled trial.

BACKGROUND: This study investigated the effects of oleoylethanolamide (OEA) supplementation on the expression levels of SIRT1, AMPK, PGC-1α, PPAR-γ, CEBP-α and CEBP-ß genes and serum neuregulin 4 (NRG4) levels in patients with non-alcoholic fatty liver diseases (NAFLD). METHODS: Sixty obese patients with NAFLD were equally allocated into either OEA or placebo group for 12 weeks. The mRNA expression levels of genes were determined using the reverse transcription polymerase chain reaction (RT-PCR) technique. Serum NRG4 level was also assessed using an enzyme-linked immunosorbent assay (ELISA) kit. RESULTS: At the endpoint, mRNA expression levels of SIRT1(p = 0.001), PGC-1α (p = 0.011) and AMPK (p = 0.019) were significantly higher in the OEA group compared to placebo group. However, no significant differences were observed in the expression levels of PPAR-γ, CEBP-α and CEBP-ß between the two groups. Serum NRG4 levels significantly increased in the OEA group compared with the placebo group after controlling for confounders (p = 0.027). In the OEA group, significant relationships were found between percent of changes in the expression levels of the SIRT1, AMPK and PGC-1α as well as serum NRG4 level with percent of changes in some anthropometric measures. Moreover, in the intervention group, percent of changes in high-density lipoprotein cholesterol was positively correlated with percent of changes in the expression levels of the SIRT1 and AMPK. While, percent of changes in triglyceride was inversely correlated with percent of changes in the expression levels of SIRT1. CONCLUSION: OEA could beneficially affect expression levels of some lipid metabolism-related genes and serum NRG4 level. "REGISTERED UNDER IRANIAN REGISTRY OF CLINICAL TRIALS IDENTIFIER NO: IRCT20090609002017N32".

Opium Use and Cancer Risk: A Comprehensive Systematic Review and Meta-Analysis of Observational Studies.

Background: Epidemiological studies have reported inconsistent associations between opium use and cancer risk. We therefore conducted a systematic review and meta-analysis to investigate the relationship between opium use and cancer risk. Methods: We searched PubMed, Scopus, ISI Web of Knowledge, and Google Scholar until February 2021 and references of retrieved relevant articles for observational studies that reported the risk of cancer in relation to opium use. Random-effects models were used to calculate pooled effect sizes (ESs) as well as 95% confidence intervals (CIs) for the association between opium use and cancer risk by considering opium doses and types, duration of consumption, and routes of opium use. Results: In total, 21 observational articles, with a total sample size of 64,412 individuals and 6,658 cases of cancer, were included in this systematic review and meta-analysis. Ever opium users, compared with never opium users, had 3.53 times greater risk of overall cancer (pooled ES: 3.53, 95% CI: 2.60-4.79, P ≤ 0.01). This positive association was also seen for some individual types of cancers except for esophageal and colon cancers. Also, we found that higher opium doses and higher duration of consumption were associated with an increased risk of overall and individual types of cancer. However, the associations between opium doses and the risk of head and neck and larynx cancers were not significant. In terms of the routes of opium use, both opium ingestion and smoking were positively associated with the risk of cancer. Regarding opium types, we found that using teriak, but not shireh, could increase the risk of cancer. Conclusions: Our findings showed that opium use, particularly in the form of teriak, is a risk factor for cancer.

Total, dietary, and supplemental calcium intake and risk of all-cause cardiovascular, and cancer mortality: a systematic review and dose-response meta-analysis of prospective cohort studies.

Considerable controversy exists regarding the association between calcium intake and mortality risk. Therefore, this study aimed to summarize available findings on the associations of total, dietary and supplemental calcium intake with all-cause, CVD, and cancer mortality. We searched PubMed, Scopus, Embase, and ISI Web of Knowledge until February 2020 to identify eligible publications. Random-effects models were used to calculate pooled effect sizes (ESs) and 95% confidence intervals (CIs) for highest versus lowest categories of calcium intake and to incorporate variation between studies. Linear and non-linear dose-response analyses were done to evaluate the dose-response relations between calcium intake and mortality. 36 publications were included in this systematic review and 35 in the meta-analysis. During the follow-up periods ranging from 4.2 to 28 years, the total number of deaths from all causes was 163,657 (83703 from CVD and 83929 from cancer). Total calcium intake was associated with a lower risk of CVD mortality (Pooled ES for highest v lowest category: 0.91; 95% CI: 0.83-0.99, I2=68.1%, P < 0.001). Dietary calcium intake was associated with a lower risk of all-cause mortality (Pooled ES for highest v lowest category: 0.95; 95% CI: 0.92-0.99, I2=62.1%, P < 0.001). Supplemental calcium intake was not significantly associated with risk of all-cause, CVD and cancer mortality. In the dose-response analysis, there was evidence of nonlinear association between calcium intake and risk of all-cause, CVD, and cancer mortality. In conclusion, a non-linear association between calcium intake with all-cause, CVD, and cancer mortality risk was observed in this meta-analysis. Moderate intake of total (1000-1800), dietary (600-1200), and supplemental calcium (600-1200) was inversely significantly associated with mortality risk but higher calcium intake was not associated with a lower risk of mortality.

Total, Dietary, and Supplemental Magnesium Intakes and Risk of All-Cause, Cardiovascular, and Cancer Mortality: A Systematic Review and Dose-Response Meta-Analysis of Prospective Cohort Studies.

A meta-analysis of prospective studies was conducted to examine the association of total, supplemental, and dietary magnesium intakes with risk of all-cause, cancer, and cardiovascular disease (CVD) mortality and identify the dose-response relations involved in these association. We performed a systematic search of PubMed, Scopus, Google Scholar, and ISI Web of Knowledge up to April 2020. Prospective cohort studies that reported risk estimates for the association between total, supplemental, and dietary magnesium intakes and risk of mortality were included. Random effects models were used. Nineteen publication with a total of 1,168,756 participants were included in the current meta-analysis. In total, 52,378 deaths from all causes, 23,478 from CVD, and 11,408 from cancer were identified during the follow-up period of 3.5 to 32 years. Dietary magnesium intake was associated with a lower risk of all-cause [pooled effect size (ES): 0.87; 95% CI: 0.79, 0.97; P = 0.009; I2 = 70.7%; P < 0.001] and cancer mortality (pooled ES: 0.80; 95% CI: 0.67, 0.97; P = 0.023; I2 = 55.7%; P = 0.027), but not with CVD mortality (pooled ES: 0.93; 95% CI: 0.82, 1.07; P = 0.313; I2 = 72.3%; P < 0.001). For supplemental and total magnesium intakes, we did not find any significant associations with risks of all-cause, CVD, and cancer mortality. However, linear dose-response meta-analysis indicated that each additional intake of 100 mg/d of dietary magnesium was associated with a 6% and 5% reduced risk of all-cause and cancer mortality, respectively. In conclusion, higher intake of dietary magnesium was associated with a reduced risk of all-cause and cancer mortality, but not CVD mortality. Supplemental and total magnesium intakes were not associated with the risk of all-cause, CVD, and cancer mortality. These findings indicate that consumption of magnesium from dietary sources may be beneficial in reducing all-cause and cancer mortality and thus have practical importance for public health.

The effects of capsinoids and fermented red pepper paste supplementation on blood pressure: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND & AIMS: The present systematic review and meta-analysis were conducted to investigate the effects of capsinoids and fermented red pepper paste (FRPP) supplementation on Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP). METHODS: Relevant studies, published up to May 2020, were searched through PubMed/Medline, Scopus, ISI Web of Science, Embase, and Google Scholar. All randomized clinical trials investigating the effect of capsinoids and FRPP supplementation on blood pressure including SBP and DBP were included. RESULTS: Out of 335 citations, 7 trials that enrolled 363 subjects were included. Capsinoids and FRPP resulted in significant reduction in DBP (Weighted mean differences (WMD): -1.90 mmHg; 95% CI, -3.72 to -0.09, P = 0.04) but no significant change in SBP (WMD: 0.55 mmHg, 95% CI: -1.45, 2.55, P = 0.588). FRPP had a significant reduction in SBP. Greater effects on SBP were detected in trials, lasted ≥12 weeks, and sample size >50. Capsinoids with dosage ≤200 and FRPP with dosage of 11.9 g significantly decreased DBP. CONCLUSION: Overall, these data suggest that supplementation with FRPP may play a role in improving SBP and DBP but for capsinoids no effects detected in this analysis on SBP and DBP.

Effects of berberine and barberry on anthropometric measures: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: Despite controversies, no study has systematically summarized findings from earlier studies on the effect of berberine and barberry on anthropometric measures. Therefore, the current systematic review and meta-analysis was conducted on the effect of berberine and barberry on body mass index (BMI), body weight (BW), waist circumference (WC) and waist-hip ratio (WHR) in adults. METHODS: Relevant studies, published up to August 2019, were searched through PubMed/Medline, Scopus, ISI Web of Science, Embase and Google Scholar. All randomized clinical trials investigating the effect of berberine and barberry on the anthropometric measures including BMI, BW, WC or/and WHR were included. RESULTS: Out of 252 citations, 12 trials that enrolled 849 subjects were included. Berberine and barberry resulted in no significant change in BMI (Weighted mean differences (WMD): -0.16 kg/m2; 95 % CI: -0.43 to 0.11, P = 0.247), BW (WMD: -0.11 kg; 95 % CI: -0.13 to 0.91, P = 0.830), and berberine resulted in not significant in WC (WMD: -0.58 cm; 95 % CI: -1.89 to 0.72, P = 0.379) and significant reduction in WHR (WMD: -0.03; 95 % CI: -0.04 to -0.01, P < 0.0001). CONCLUSION: We found a significant reduction in WHR following berberine consumption in adults. Further clinical trials with high quality according to challenges mentioned seem to be helpful to use berberine and barberry as a supplement for certain health conditions, efficiently.