Omega-3 fatty acids and endothelial function: A GRADE-assessed systematic review and meta-analysis.

INTRODUCTION: N-3 polyunsaturated fatty acids (PUFAs) supplementation has been reported to have an impact on flow-mediated dilatation (FMD), a conventionally used clinical technique for estimating endothelial dysfunction. However, its proven effects on endothelial function are unclear. This systematic review and meta-analysis were conducted to evaluate the effects of n-3 PUFAs supplementation on FMD of the brachial artery. METHOD: This study was performed following the PRISMA guidelines. To identify eligible RCTs, a systematic search was completed in PubMed/Medline, Scopus and Web of Science using relevant keywords. A fixed- or random-effects model was utilized to estimate the weighted mean difference (WMD) and 95% confidence interval (95% CI). RESULTS: Thirty-two studies (with 35 arms) were included in this meta-analysis, involving 2385 subjects with intervention duration ranging from 4 to 48 weeks. The pooled meta-analysis demonstrated a significant effect of omega-3 on FMD (WMD = 0.8%, 95% CI = 0.3-1.3, p = .001) and heterogeneity was significant (I2 = 82.5%, p < .001). CONCLUSION: We found that n-3 PUFA supplementation improves endothelial function as estimated by flow-mediated dilatation of the brachial artery.

The effect of Spirulina supplementation on lipid profile: GRADE-assessed systematic review and dose-response meta-analysis of data from randomized controlled trials.

BACKGROUND: Cardiovascular diseases (CVD) are one of the most important causes of death worldwide. Dyslipidemia is one of the main causal risk factors for CVD that can be controlled by modifying lifestyle, which entails the use of healthy diets containing functional foods. The present study was conducted to summarize the effects of Spirulina on the lipid profile in previous randomized controlled trials. METHODS: MEDLINE, Scopus, Clarivate Analytics Web of Science, and the Cochrane Library databases were searched systematically until January 2023, for clinical interventions that investigated the effect of Spirulina supplementation on plasma lipid profile concentrations. RESULTS: ooled results of 20 studies (with 23 arms and 1076 participants) indicated that Spirulina intervention significantly reduced LDL-C (SMD: -0.6, 95% CI: -0.9, -0.2, P<0.05), TC (SMD: -0.6, 95% CI: -0.9, -0.2, P<0.05) and TG (SMD: -0.6, 95% CI: -0.9, -0.2, P<0.05) levels while HDL-C levels were significantly increased (SMD: 0.3, 95% CI: 0.0, 0.6, P<0.05). CONCLUSIONS: The findings of the present meta-analysis and review show the usefulness of supplementing with Spirulina in improving serum levels of TC, TG, LDL-C, and HDL-C.

The effects of Quercetin supplementation on cardiometabolic outcomes: An umbrella review of meta-analyses of randomized controlled trials.

BACKGROUND: Quercetin is a bioactive flavonoid, but the effect of it on cardiometabolic factors has remained uncertain and previous findings from meta-analyses have been controversial. OBJECTIVE: To provide an overview of the effects of Quercetin on cardiometabolic factors based on meta-analyses of randomized controlled trials (RCTs). METHOD: MEDLINE, SciVerse Scopus, and Clarivate Analytics Web of Science databases were searched to identify eligible publications. As part of the umbrella review, we summarized pooled estimates, 95% CIs, heterogeneity, and publication bias. A GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach was used to rate the certainty of evidence. RESULTS: Five meta-analyses including 18 eligible RCTs plus 5 RCTs that were not included in previous meta-analyses were found. The results indicated Quercetin does not affect diastolic blood pressure (DBP), lipid profile, inflammation, anthropometric indices, fasting plasma glucose (FBG), and homeostatic model assessment for insulin resistance (HOMA-IR). However, Quercetin supplementation could significantly reduce systolic blood pressure (SBP) (weighted mean difference (WMD): -1.9, 95% CI = -3.2 to -0.6, I2 = 88.3%) and insulin level (WMD: -1.07, 95% CI = -1.9 to -0.1, I2 = 75.0%). The certainty of evidence ranged from very low to moderate. CONCLUSION: Quercetin supplementation has reducing effects on SBP and insulin levels but not other cardiometabolic parameters. More high-quality trials with longer follow-up durations may be required to obtain a more robust conclusion.

Impact of synbiotic supplementation on cardiometabolic and anthropometric indices in patients with metabolic syndrome: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Probiotic and synbiotic products are being widely used by a large number of patients and clinicians; however, effects on cardiometabolic indices in patients with the metabolic syndrome remain unclear. This meta-analysis aimed to evaluate the effects of a synbiotic intervention on lipid profile, insulin resistance, blood pressure, anthropometric parameters, and inflammatory markers. METHODS: We searched MEDLINE, Scopus, and Clarivate Analytics Web of Science by October 2021. Studies were selected if they reported the effectiveness of the synbiotic intervention on cardiometabolic and anthropometric indices. The weighted mean difference was calculated as the effect size using a random-effects model. Subgroup analyses were conducted to determine sources of heterogeneity. Dose-dependent effects were assessed using a dose-response meta-analysis of differences in means. RESULTS: Five trials (1049 participants) were finally included in the meta-analysis. Synbiotic intervention significantly reduced serum insulin levels (WMD, -6.39 µU/mL; 95%CI, (-7.2 to -5.4); p = 0.001, I2 = 88.2%, N = 5), triglycerides (WMD, -20.3 mg/dl; 95%CI, (-32.7 to -7.8); p = 0.001, I2 = 87.7, N = 5), total cholesterol (WMD, -7.8 mg/dl; 95%CI, ( -12.5 to -3.02); p = 0.001; I2 = 66.7%, N = 5), low-density lipoprotein cholesterol (WMD, -9.02 mg/dl; 95%CI, (-10.8 to -7.2); p < 0.001, I2 = 0%, N = 5), waist circumference (WMD, -4.04 cm; 95%CI, ( -4.9 to -3.08), p < 0.001; I2 = 22.7%, N = 3), body weight (WMD, -4.3 kg; 95%CI, (-6.2 to -2.5); p = 0.001; I2 = 0%, N = 2), systolic blood pressure (WMD, -1.8 mmHg; 95% CI, (-2.8 to -0.7); p = 0.001; I2 = 0%, N = 3), and serum interleukin-6 concentrations (WMD, -0.2 pg/mL; 95%CI, (-0.3 to -0.08); p = 0.001, I2 = 39.8%, N = 2), and increased high-density lipoprotein cholesterol levels (WMD, 2.3 mg/dl; 95%CI, (0.2-4.4); p = 0.03; 03; I2 = 93.1%, N = 5). Synbiotic administration did not significantly affect fasting plasma glucose, homeostatic model assessment for insulin resistance, body mass index, diastolic blood pressure, heart rate, and serum C-reactive protein concentrations. CONCLUSIONS: The present findings suggest that synbiotic intervention effectively improves cardiometabolic risk factors in patients with metabolic syndrome.

Impact of walnut consumption on cardio metabolic and anthropometric parameters in metabolic syndrome patients: GRADE-assessed systematic review and dose-response meta-analysis of data from randomized controlled trials.

BACKGROUND: In recent years, the effect of walnut consumption on various components of metabolic syndrome (Mets) in different populations has been investigated. However, the findings on the alterations of cardiometabolic and anthropometric indices following walnut consumption in adults with Mets have not been fully conclusive. METHODS: The current study of eight randomized controlled trials (RCTs) examined the effects of walnut consumption on glucose homeostasis factors (fasting plasma glucose (FPG), insulin, hemoglobin A1C (HbA1c)), lipid profile (triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), and high-density lipoprotein cholesterol (HDL-c)), high sensitivity C-reactive protein (hs-CRP) concentrations and anthropometric indices (body weight (BW), body mass index (BMI), and waist circumference (WC)) in trials of 549 participants. A systematic search was conducted in online databases including MEDLINE, Scopus, and Clarivate Analytics Web of Science uses related keywords to detect eligible studies until December 2021. To calculate the weighted mean difference (WMD) and 95% confidence intervals (CIs), a random-effects model was used. RESULTS: Results from the pooled analysis showed that serum TG concentration was significantly reduced (WMD, - 0.1 mmol/L; 95%CI (- 0.3 to - 0.02); p = 0.02; I2 = 38.6%; p = 0.10), although other lipid profile components (TC, LDL-c, and HDL-c), glucose homeostasis markers (FPG, insulin, and HbA1c), hs-CRP levels, anthropometric indices (BW, BMI, and WC) and blood pressure (SBP and DBP) were not influenced by walnut consumption. A significant dose-response association was detected between the dose of walnut intake and serum concentrations of FPG (Pnon-linearity < 0.03, Pdose-response < 0.001) and HDL-c (Pnon-linearity = 0.01, Pdose-response = 0.006). CONCLUSIONS: Walnut consumption reduces serum TG levels in individuals with metabolic syndrome, but it cannot affect other cardiometabolic indices. Future well-designed and large RCTs are required to clarify further beneficial effects of walnut consumption on the cardiometabolic profile.

Identifying the Predictors of Short Term Weight Loss Failure after Roux-En-Y Gastric Bypass.

Introduction: Gastric bypass surgery is a gold standard therapy for severe obesity. This study aimed to evaluate anthropometric predictors for short-term excess weight loss (EWL) after Roux-en-Y gastric bypass surgery (RYGB) in a sample of severely obese patients. Materials and Methods: This cohort study was conducted on severely obese candidates for RYGB bariatric surgery in Mashhad, Iran. Indirect calorimetry, anthropometric measurements, and body composition data were collected before, one, and six months after RYGB. Results: Fifty-four participants (43, 79.6% women and 11, 20.4% men) with a mean age of 39.63 ± 9.66 years participated in this study. The mean total weight and BMI loss within six months were 32.89 ± 20.22 kg and 12.37 ± 7.34 kg/m2, respectively. The mean reduction in adipose tissue and fat-free mass was 24.49 kg and 7.46 kg, respectively. The mean resting metabolism rate (RMR) reduction at one and six months after RYGB was 260.49 kcal and 396.07 kcal, respectively. There was a significant difference in mean RMR between the baseline and one and six months after RYGB (p < 0.001). There was no significant gender difference in mean weight and BMI loss percentage at six months post-RYGB (p > 0.05). Baseline skeletal muscle mass (SMM), excess BMI loss (EBMIL) at first month after surgery, and baseline neck circumference (NC) could predict EWL six months after surgery. Conclusion: Reduced RMR shortly after RYGB may be due to FFM reduction. Some anthropometric and their acute changes after RYGB may predict the short-term EWL in RYGB patients.

The effects of curcumin-containing supplements on inflammatory biomarkers in hemodialysis patients: A systematic review and meta-analysis.

In the past decade, the effect of curcumin or turmeric supplementation on many aspects of health status in different populations has been evaluated. In the present study, a systematic review and meta-analysis were conducted to estimate the effect of curcumin administration on inflammatory markers in hemodialysis (HD) patients. A systematic search was performed in MEDLINE, EMBASE, Scopus, and Clarivate Analytics Web of Science databases from 1997 until June2022 for terms related to curcumin/turmeric and hemodialysis (HD). Randomized, double-blind/single-blind studies examining the effects of curcumin/turmeric on the inflammation of HD participants older than 18 years were considered eligible for inclusion. Data were pooled using the weighted mean difference (WMD) and 95% CI as the summary statistic, considering a random-effects analysis model. The data that were pooled from nine studies with 472 patients indicated that curcumin-containing supplement had significant effect on serum C-reactive protein (CRP) levels (WMD = -3.3 mg/L; 95% CI: -5.4 to -1.3; p < 0.001, I2  = 76.7%, 8 studies, 467 participants), and interlukine-6 (IL-6) levels (SMD: -0.4; 95% CI: -0.8 to -0.07; p = 0.02, I2  = 31.6%, 3 studies, 153 participants) compared control group. Although curcumin intervention could not change tumor neurosis factor-α (TNF-α) concentration (SMD = -0.3; 95% CI: -0.7 to 0.04; p = 0.08, I2  = 25.3%, 3 studies, 153 participants), when compared with the placebo group. Our study's main limitations were small number of studies, overall high risk of bias in the included trials, and high heterogeneity in some results. The present meta-analysis suggested that intervention with curcumin-containing supplements was associated with a significant reduction in serum hs-CRP and IL-6 concentrations in HD patients. The curcumin intervention in the reduction of hs-CRP levels was greater than the minimal clinically important difference (MCID) for CRP (0.5 mg/L), which can be helpful in physicians' clinical decisions.

The effect of statin therapy in combination with ezetimibe on circulating C-reactive protein levels: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Previous studies have reported that statin or ezetimibe therapy has an anti-inflammatory effect. However, the results of individual studies on the effect of statin therapy in combination with ezetimibe on C-reactive protein (CRP) and high-sensitivity CRP (hs-CRP) levels have not been clear. Therefore, the present systematic review and meta-analysis were conducted on randomized clinical trials (RCTs) to evaluate the effect of statin therapy in combination with ezetimibe on CRP and hs-CRP levels. METHODS: A literature search was carried out on the MEDLINE, SciVerse Scopus, and Clarivate Analytics Web of Science databases up to February 2022 to find eligible studies. The pooled effect sizes were considered for weighted mean difference (WMD) and 95% confidence intervals (CI) for CRP and hs-CRP, and it was also determined as standardized weighted mean difference (SMD) for overall CRP. For all variables, a random-effects model was used. RESULTS: Of the 57 studies included in the systematic review, 53 were used for meta-analysis. Statin therapy in combination with ezetimibe significantly reduced the serum levels of hs-CRP (WMD - 0.2 mg/l; 95% CI - 0.4, - 0.1, P ˂ 0.001) and overall CRP (SMD - 0.16 mg/l; 95% CI - 0.2, - 0.07, P ˂ 0.001). Nevertheless, CRP levels were not significantly changed by combination therapy. A significant association was observed between the serum low-density lipoprotein cholesterol (LDL-C) changes and hs-CRP levels, which can justify the source of heterogeneity. CONCLUSIONS: The current study showed that statin therapy in combination with ezetimibe could be effective in reducing the levels of hs-CRP and overall CRP.

The effect of beetroot inorganic nitrate supplementation on cardiovascular risk factors: A systematic review and meta-regression of randomized controlled trials.

OBJECTIVES: Inorganic nitrate is one of the most effective compounds in beetroot for improving cardiovascular function due to its conversion to nitric oxide in the body. This review and meta-analysis aimed to investigate the role of beetroot inorganic nitrate supplementation on adults' cardiovascular risk factors. METHODS: We conducted a systematic literature review of articles published without time limitation until November 2020 in PubMed, Embase, ISI Web of Science, Scopus, Cochrane Library, and gray literature databases. We included the original randomized clinical trials (RCTs) in which the effect of beetroot inorganic nitrate supplementation on endothelial function, arterial stiffness, and blood pressure was studied. RESULTS: 43 studies were included for qualitative synthesis, out of which 27 were eligible for meta-analysis. Beetroot inorganic nitrate supplementation significantly decreased Arterial Stiffness (Pulse Wave Velocity (-0.27 m/s, p = 0.04)) and increased Endothelial function (Flow Mediated Dilation: 0.62%, p = 0.002) but did not change other parameters (p > 0.05). CONCLUSION: Beetroot inorganic nitrate supplementation might have a beneficial effect on cardiovascular risk factors. Further high-quality investigations will be needed to provide sufficient evidence.

The effect of vitamin D supplementation on hemoglobin concentration: a systematic review and meta-analysis.

AIMS: The purpose of this review was to investigate the effect of vitamin D supplements on hemoglobin concentration in subjects aged 17.5-68 years old; using randomized controlled trials (RCTs). METHODS: Relevant RCT studies were identified from January 2000 to January 2019 by using MeSH terms in PubMed, Embase, Cochrane Library, Clinical trials, Scopus databases and gray literature. The studies were reviewed systematically, and quality assessments were evaluated by the guidelines of the Cochrane risk of bias. The effect of vitamin D supplements (n = 14) on hemoglobin concentration was considered as primary outcome, while its effects on the levels of ferritin, transferrin saturation and iron status were derived as secondary outcomes. In total, 1385 subjects with age range of 17.5 to 68 years old were examined for 3 h to 6 months; Mean (standard deviation) or median interquartile changes in the hemoglobin concentration in each treatment group was recorded for meta-analysis. RESULTS: Fourteen RCTs met the inclusion criteria. Current study findings propose that vitamin D supplementation leads to a non-significant reduction in hemoglobin levels in subjects (17.5-68 years old) [std. mean difference (SMD): 0.01; 95% CI: - 0.28, 0.29; P = 0.95], also it has no significant effect on ferritin concentrations [std. mean difference (SMD): -0.01; 95% CI: [- 0.20, 0.18; P = 0.91]. However, vitamin D supplementation demonstrated positive effects on transferrin saturation [mean difference (MD): 1.54; 95% CI: 0.31, 2.76; P = 0.01] and iron status [std. mean difference (SMD): 0.24; 95% CI: - 0.09, 0.39; P = 0.002]. CONCLUSION: Current review concluded that supplementation with vitamin D had no significant effect on hemoglobin and ferritin levels while positive effects on transferrin saturation and iron status were observed. Further clinical studies are required to determine the actual effect of this intervention on hemoglobin levels.

Statin Therapy and Flow-Mediated Dilation: A Systematic Review and Dose-Response Meta-Analysis Using the GRADE of Data from Randomized Controlled Trials.

INTRODUCTION: A previous meta-analysis reported the positive effects of statin therapy on endothelial function. However, the obtained result had several limitations that necessitated updating the information in this field. Therefore, a systematic and meta-analysis review was conducted to determine whether statin therapy could improve endothelial function, as assessed by flow-- mediated dilation (FMD). METHODS: MEDLINE, SciVerse Scopus, and Clarivate Analytics Web of Science were searched to identify randomized placebo-controlled trials assessing the impact of statin therapy on FMD. A random-effects model was used for meta-analysis to calculate the mean difference in weight. Meta- regression and subgroup analyses were used to identify sources of heterogeneity. In addition, nonlinear dose-response, quality of evidence, influence analysis, and publication bias evaluation were assessed using standard methods. RESULT: Thirty-five trials (41 arms) involving 2178 participants were included in the meta-analysis study. Statin treatment significantly improved FMD [weighted mean difference (WMD): 1.7%, 95% CI: 1.3-2.2, p < 0.001). However, significant heterogeneity was observed (I2=97.9%, p < 0.001). The results of the subgroup analysis showed that health status can contribute to heterogeneity. Non-linear dose-response analysis revealed the most significant improvement in FMD with atorvastatin at a dose of 20 mg/day and simvastatin at 80 mg/day. CONCLUSION: Statin therapy significantly improved endothelial function, as assessed by FMD. These changes are clinically significant, but their use should be approached with caution.

The effect of oral supplementation of Paricalcitol on C-reactive protein levels in chronic kidney disease patients: GRADE-assessed systematic review and dose-response meta-analysis of data from randomized controlled trials.

BACKGROUND: Previous studies investigating the effect of oral supplementation of paricalcitol on reactive protein levels in chronic kidney disease (CKD) patients reported inconsistent findings. In this systematic review and meta-analysis, we have analyzed and interpreted the results obtained from previous randomized clinical trials on the effect of paricalcitol on C-reactive protein in CKD patients in the literature. METHODS: MEDLINE, SciVerse Scopus, and Clarivate Analytics Web of Science databases were searched until January 2023 and related articles were obtained through a careful screening process allowing extraction of required data from selected articles. The effect size was calculated using a random effect model and weighted mean differences (WMD) and 95% confidence intervals (CI). Heterogeneity among studies was evaluated using Cochran's Q test and I2. RESULTS: Amongst the 182 articles obtained from the initial search, 4 studies (6 arms) were finally included in the meta-analysis. Pooled analysis shows that C-reactive protein levels significantly decrease after oral supplementation with paricalcitol (WMD: -2.55 mg/L, 95% CI (-4.99 to -0.11; P = 0.04). The studies used in this meta-analysis showed significant heterogeneity (I2 = 66.3% and P = 0.01). CONCLUSION: Oral paricalcitol supplementation in CKD patients can significantly reduce C-reactive protein levels, which may prevent CKD progression.

The Effect of Ginseng Supplementation on Lipid Profile: GRADE-assessed Systematic Review and Dose-response Meta-analysis of Randomized Controlled Trials.

BACKGROUND: This systematic review and meta-analysis aimed to evaluate the overall impact of Panax ginseng on lipid profile by synthesizing existing evidence. Cardiovascular Disease (CVD) is the leading cause of morbidity and mortality among the elderly population, and serum lipids play a crucial role in its development. Maintaining optimal levels of triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and total cholesterol is essential in reducing the risk of CVD. Ginsenosides, the active constituents in ginseng, have shown positive effects on lipid metabolism. This review aimed to provide a comprehensive understanding of the potential benefits of ginseng in managing dyslipidemia, which could have significant implications for the prevention and treatment of CVD. METHODS: A comprehensive analysis of 29 Randomized Controlled Trials (RCTs) was conducted to assess the effects of ginseng supplementation on lipid profile, including Triglyceride (TG), Total Cholesterol (TC), High-density Lipoprotein Cholesterol (HDL-C), and Low-density Lipoprotein Cholesterol (LDL-C) levels. A systematic search was done in online databases, such as MEDLINE, Scopus, and Clarivate Analytics Web of Science, using relevant keywords and MeSH terms to identify relevant studies until January 2024. RESULTS: The Weighted Mean Differences (WMD) and 95% Confidence Intervals (CI) for TG, TC, LDL-C, and HDL-C did not show significant changes with ginseng supplementation. CONCLUSION: Taking into account the results, using ginseng did not have a statistically significant influence on lipid profile parameters in individuals with different health conditions. Further, well-designed RCTs focusing on specific diseases are needed to clarify the potential beneficial effects of ginseng and its derivatives on lipid profile.

The effect of l-carnitine supplementation on mortality and clinical outcomes in ventilator-dependent critically ill patients with obesity and COVID-19: Protocol for a randomized double-blind placebo-controlled trial.

Background: Coronavirus disease 2019 (COVID-19) still remains a pandemic accounting for at least 15% of intensive care unit (ICU) admissions. Recently, it has been observed that l-carnitine levels, which play an important role in fatty acid metabolism, have an inverse association with the severity of COVID-19 and its complications, hence a potential role for supplementing with this nutraceutical has been suggested. The current protocol describes a trial aiming to an evaluation of the effect of l-carnitine intervention on mortality and clinical outcomes in ICU-admitted patients with COVID-19. Methods: This parallel-group, randomized, placebo-controlled, and double-blind clinical trial involves 50 participants and will be performed at the ICU of Artesh (AJA) Hospital, Mashhad, IRAN. Eligible participants will be randomized into two groups: 1) the intervention group will receive 1000 mg l-carnitine capsules 3 times a day, and 2) the placebo group will receive 1000 mg placebo capsules 3 times a day. Assessments will be performed at baseline, 7 and 28 days after study initiation. The primary outcome includes changes in serum levels of C-reactive protein (CRP). Secondary outcomes include the length of stay in the ICU, ICU mortality, hospital mortality, 28-day mortality, duration of mechanical ventilation (MV), and the neutrophil-lymphocyte ratio (NLR). Conclusion: Based on previous evidence, l-carnitine may reduce inflammation and oxidation stress and improve respiratory function. However, the effects of l-carnitine on ventilator-dependent COVID-19 critically ill patients have not been assessed yet, justifying the necessity to conduct a clinical study in this field. c.

Effect of beetroot or beetroot plus vitamin C supplementation on cardiovascular function in patients with coronary artery disease: protocol for a double-blind, placebo-controlled, randomised trial.

INTRODUCTION: Coronary artery disease (CAD), classified into the atherosclerosis category, is a prevalent cardiovascular disease worldwide that is associated with serious comorbidities and death. The purpose of this study was to evaluate the effect of beetroot/beetroot plus vitamin C on cardiovascular health status and function in patients with CAD. METHOD AND ANALYSIS: A randomised, placebo-controlled, double-blind clinical trial to recruit 90 patients with CAD at the cardiac outpatient clinic and Imam Reza Hospital, Mashhad, Iran. Participants will be divided into three groups: (1) Those who receive 500 mg three times a day of beetroot capsules, (2) Those who receive 500 mg three times a day of beetroot plus vitamin C capsules, and (3) Those who receive placebo capsules three times a day for 4 weeks. Pulse wave velocity, Augmentation Index, heart rate, volume of oxygen (VO2) max/VO2 peak, peak heart rate, blood pressure, interleukin 6 (IL-6), high sensitivity C reactive protein, intercellular adhesion molecule, vascular cell adhesion molecule, lipid profile and anthropometry will be measured at the beginning and end of the intervention. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of Mashhad University of Medical Sciences (IR.MUMS.MEDICAL.REC.1399.717). All participants will be asked to complete the consent form at the beginning of the study. The results will be actively disseminated through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Iranian Registry of Clinical Trials, IRCT20210217050393N1 (registered 16 May 2021).

The effects of saffron supplementation on the measures of renal function indicators: a systematic review and meta-analysis.

CONTEXT: Saffron (Crocus sativus L.) has been proposed as a potential agent to improve renal function in animal studies. But, due to insufficient evidence in human research, further investigation is needed. OBJECTIVE: To fill this knowledge gap, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of saffron supplementation on the measures of renal function indicators in adults. Renal function was assessed based on serum urea, blood urea nitrogen, and creatinine levels. METHOD AND MATERIALS: A systematic search in PubMed/Medline, Scopus, Web of Science, Embase, and Google Scholar databases was done until March 2021 using relevant keywords. A random-effects model was used to estimate the weighted mean difference (WMD) and 95% confidence (95% CI). Nine RCTs were included in the meta-analysis, and their quality was assessed using the Cochrane risk of bias tool. RESULTS: The pooled analysis showed that saffron supplementation had no significant effect on serum urea concentrations (WMD: - 1.05 mg/dl; 95% CI - 5.1 to 3; P = 0.6, I2 = 93%, P < 0.001) and serum creatinine levels (WMD: - 0.006 mg/dl; 95% CI - 0.08 to 0.06; P = 0.8, I2 = 79%, P < 0.001) when compared to the placebo group. In the dose-response analysis, we observed a significant non-linear relationship between the duration of saffron supplementation and serum urea and creatinine levels. CONCLUSIONS: Based on our findings, Saffron supplementation had no significant effect on renal function markers, including urea and creatinine. However, further trials are required to determine the actual effect and safety of saffron intervention in human studies. PROSPERO SUBMISSION ID: 248081.

Effects of raw red beetroot consumption on metabolic markers and cognitive function in type 2 diabetes patients.

OBJECTIVES: This study aimed to investigate the effects of raw red beetroot consumption on metabolic markers and cognitive function in type 2 diabetes patients. METHODS: In a quasi-experimental study, 44 type 2 diabetes patients (57 ± 4.5 years) consumed raw red beetroot (100 g, daily), for 8 weeks. Metabolic markers including body weight, glucose and lipid profile parameters, inflammatory and oxidative stress markers, paraoxonase-1 activity, hepatic enzymes, blood pressure and cognitive function were measured at the beginning and end of 8 weeks. RESULTS: Raw red beetroot consumption resulted in a significant decrease in fasting blood sugar (FBS) levels (-13.53 mg/dL), glycosylated hemoglobin (HbA1c)(-0.34%), apolipoproteinB100 (ApoB100) (-8.25 mg/dl), aspartate aminotransferase (AST) (-1.75 U/L), alanine aminotransferase (ALT) (-3.7 U/L), homocysteine (-7.88 µmol/l), systolic (-0.73 mmHg) and diastolic blood pressure (-0.34 mmHg), anda significant increase in total antioxidant capacity (TAC) (105 µmol/L) and cognitive function tests (all P values <0.05). Other variables did not change significantly after the intervention. CONCLUSIONS: Raw red beetroot consumption for 8 weeks in T2DM patients has beneficial impacts on cognitive function, glucose metabolism and other metabolic markers.