The Effectiveness of Nonsurgical Interventions for Weight Loss Maintenance in Adults: An Updated, GRADE-Assessed Systematic Review and Meta-Analysis of Randomized Clinical Trials.

CONTEXT: Today, there are many discussions about the best way to maintain weight and prevent weight regain after a period of weight loss. OBJECTIVES: The aim of this study was to summarize, based on data from randomized clinical trials (RCTs), the impact of nonsurgical interventions for adults' weight loss maintenance. DATA SOURCES: The Medline (PubMed), Scopus, and Web of Science databases were reviewed during June 2023. DATA EXTRACTION: Meta-analyses assessing the impacts of nonsurgical interventions for weight loss maintenance were conducted. Effect sizes of nutritional interventions were recalculated by applying a random-effects model. The Grading of Recommendations, Assessment, Development, and Evaluation framework was implemented to determine evidence certainty. RESULTS: Meta-analysis of data from a total of 56 RCTs (n = 13 270 participants) represented a significant weight reduction after behavior and lifestyle interventions (mean difference [MD], -0.64 kg [95% CI, -1.18 to -0.09]; I2 = 89.5%; P < .001 for heterogeneity). Pharmacological interventions had also a significant effect on weight change during the weight maintenance phase (MD, -2.57 kg [95% CI, -3.12 to -2.02]; I2 = 91.6%; P < .001 for heterogeneity). The weight loss reduction from pharmacological interventions was greater with sibutramine (MD, -2.57; 95% CI: -3.12 to -2.02). Additionally, diet intervention and dietary and physical activity strategies were associated with a negligible trending decrease in weigh regain (respectively: MD, -0.91 kg [95% CI, -2.18 to 0.36], I2 = 55.7%, P = .016 for heterogeneity; and MD, -0.3 kg [95% CI, -4.13 to 3.52], I2 = 94.1%, P < .001). CONCLUSION: The findings of this review indicate there is a favorable impact of behavior-based interventions and antiobesity medications on weight maintenance. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no CRD42023468056.

Higher dietary choline intake is associated with increased risk of all-cause and cause-specific mortality: A systematic review and dose-response meta-analysis of cohort studies.

Evidence indicates that choline and betaine intakes are associated with mortality. Based on the available evidence, we hypothesized that dietary choline and betaine do not increase mortality risk. This meta-analysis was conducted to investigate the association of dietary choline and betaine with mortality from all causes, cardiovascular diseases, and stroke. Online databases including PubMed, Scopus, Web of Science, Embase, and Google Scholar were searched up to 9 March 2024. Six cohort studies comprising 482,778 total participants, 57,235 all-cause, 9351 cardiovascular disease, and 4,400 stroke deaths were included in this study. The linear dose-response analysis showed that each 100 mg/day increase in choline intake was significantly associated with 6% and 11% increases in risk of all-cause (RR = 1.06, 95% CI: 1.03, 1.10, I2 =83.7%, P < .001) and cardiovascular diseases mortality (RR = 1.11, 95% CI: 1.06, 1.16, I2 = 54.3%, P = .02) respectively. However, dietary betaine, was not associated with the risk of mortality. Furthermore, the result of the nonlinear dose-response analysis showed a significant relationship between betaine intake and stroke mortality at the dosages of 50 to 250 mg/day (Pnon-linearity= .0017). This study showed that each 100 mg/day increment in choline consumption was significantly associated with a 6% and 11% higher risk of all-cause and cardiovascular disease mortality respectively. In addition, a significant positive relationship between betaine intake and stroke mortality at doses of 50 to 250 mg/day was observed. Due to the small number of the included studies and heterogeneity among them more well-designed prospective observational studies considering potential confounding variables are required.

Correction: Theobromine supplementation in combination with a low-calorie diet improves cardiovascular risk factors in overweight and obese subjects with metabolic syndrome: a randomized controlled trial.

Correction for 'Theobromine supplementation in combination with a low-calorie diet improves cardiovascular risk factors in overweight and obese subjects with metabolic syndrome: a randomized controlled trial' by Elham Sharifi-Zahabi et al., Food Funct., 2023, 14, 8431-8441, https://doi.org/10.1039/D3FO00555K.

Effect of silymarin on lipid profile and glycemic control in patients with type 2 diabetes mellitus.

This randomized clinical trial was conducted to evaluate the effects of silymarin supplementation on glycemic indices and serum lipid profile in type 2 diabetes mellitus (T2DM) patients. In this open-label randomized clinical trial study, 48 patients with T2DM were eligible to participate for 12 weeks and were divided into two groups randomly: 24 subjects in the intervention (received three 140 mg silymarin capsules daily and diet plan) and 24 in control (received a diet plan). Fasting blood samples and anthropometric data were collected, and glycemic indices and lipid profiles were determined at baseline and at the end of the study. Out of 60 patients included in the clinical trial, 48 people completed the study. In comparing silymarin and control groups before and after the study, a significant reduction was observed in weight and body mass index. However, after adjustment, no significant difference was seen between the two groups. Furthermore, daily consumption of three capsules of 140 mg silymarin for 12 weeks did not show any significant difference on the level of fasting blood sugar (p = 0.789), HbA1c (p = 0.719), and lipid profile. The findings of the present study show that silymarin did not lead to changes in the level of glycemic index and lipid profile in patients with T2DM.

The impact of synbiotic on serum sCD163/sTWEAK, paraoxonase 1, and lipoproteins in patients with chronic heart failure: a randomized, triple-blind, controlled trial.

Cardiovascular disease is one of the leading causes of death worldwide. Evidence suggests that alterations in the gut microbiome could play a role in cardiovascular diseases, including heart failure. The purpose of this study was to evaluate the effect of synbiotics on serum paraoxonase 1(PON1), soluble CD163/soluble TNF-like weak inducer of apoptosis (sCD163/sTWEAK), and lipid profile, which are involved in heart failure in patients with chronic heart failure. In this triple-blind randomized clinical trial, 90 eligible patients were included in the study. They were randomly assigned to receive one capsule (500 mg) of synbiotics or a placebo daily for ten weeks. Serum PON1, sCD163/sTWEAK, and lipid profiles were measured at the beginning and end of the study. The data were analyzed by SPSS 24, and the p-value < 0.05 was considered statistically significant. Among 90 patients who met the inclusion criteria, 80 completed the study. The primary outcomes showed a small effect on sTWEAK, with an adjusted standard mean difference (SMD) of 0.2. However, no significant changes were observed in sCD163/sTWEAK (SMD: 0.16). Secondary outcomes indicated no changes in PON1, total cholesterol (TC), or LDL-C levels. However, there was an increase in HDL-C levels (adjusted SMD: 0.46, 95% CI: 0.02-0.91) and a decrease in TG and TC/HDL levels (adjusted SMD: - 0.5 and - 0.3, respectively) in the synbiotic group. A favorable effect of synbiotics on sTWEAK, HDL, TG, and TC/HDL of patients with heart failure was observed, but no statistically significant effect was found on sCD163/sTWEAK, PON1, LDL, and TC factors.

Does a High Ratio of Dietary Omega-6/Omega-3 Fatty Acids Increase the Risk of Helicobacter pylori Infection? A Case-Control Study.

Helicobacter pylori infection is the cause of 90% of non-cardia gastric cancer. Several dietary elements have been identified as possible contributors to H. pylori infection and its advancement through various pathways. Based on the anti-inflammatory and anti-microbial effects of a diet low in omega-6 and high in omega-3 polyunsaturated fatty acids (PUFAs), this study aimed to assess the ratio of dietary omega-6 to omega-3 PUFAs and the risk of developing H. pylori. The present case-control study was conducted on 150 cases with H. pylori infection and 302 controls. The omega-6 to omega-3 ratio was calculated using food intake information sourced from a validated food frequency questionnaire. Physical activity and demographic data were collected through a related questionnaire. The association between the odds of H. pylori infection and the omega-6 to omega-3 ratio was evaluated using logistic regression models. A p value < 0.05 was considered statistically significant. The findings revealed that individuals in the third tertile had significantly higher odds of H. pylori (odds ratio [OR], 2.10; 95% confidence interval [CI], 1.30-3.40) in the crude model. Furthermore, even after adjusting the potential confounders including sex, age, body mass index, physical activity, energy intake, alcohol, and smoking status, this association remained significant (fully adjusted model: OR, 2.00; 95% CI, 1.17-3.34). Our study revealed a higher ratio of omega-6 to omega-3 was related to a higher likelihood of H. pylori infection. Therefore, it is advisable to maintain a balanced intake of PUFAs in the diet.

Ultra-Processed food intake and risk of Helicobacter pylori infection: A case-control study.

The components in our food are known as one of the important risk factors for the development of Helicobacter pylori (H. pylori) infection. A balanced diet, rich in fruits and vegetables, and free of fat, sugar, and salt, might protect people from the consequences of H. pylori infection. Therefore, the purpose of this study was to investigate the associations between ultra-processed foods (UPFs) intake and the risk of H. pylori infection. The case-control study was conducted to assess the intake of UPFs in patients with H. pylori infection compared with healthy individuals. The dietary data of the contributors were collected by a validated food frequency questionnaire (FFQ). To estimate the UPFs intake, the classification of the NOVA food group was utilized. The associations of intake UPFs with H. pylori infection were assessed using binary logistic regression. Finally, dietary data of 150 cases and 302 controls (mean age: 39.5 ± 10.95 years) were analyzed. UPFs intake was associated with higher risk of H. pylori infection (odds ratio (OR) = 1.71; 95% confidence interval (CI): 1.05, 2.79). The association remained constant after adjustment for age, body mass index (BMI), sex, energy intake, physical activity, smoking, and alcohol status (OR = 2.17; 95% CI: 1.22, 3.86). Our data declare that UPFs consumption could have a role in increasing the likelihood of the risk of H. pylori infection. To confirm the current findings, prospective studies are suggested.

Effects of a low FODMAP diet on the symptom management of patients with irritable bowel syndrome: a systematic umbrella review with the meta-analysis of clinical trials.

A low FODMAP diet (LFD) is a common restrictive diet to manage the symptoms of irritable bowel syndrome (IBS). However, there is no consensus on the alleviating effects of this diet. Herein, a systematic umbrella review with meta-analysis was conducted to investigate the effect of an LFD on IBS symptoms and its secondary outcomes in patients, which were not reported in previous meta-analyses. We performed a systematic literature search in PubMed, Scopus, and ISI Web of Science up to December 2023. The methodological quality of systematic reviews and their included trials was evaluated using AMSTAR 2 and the Cochrane risk of bias, respectively. The certainty of the evidence tool was evaluated using the GRADE approach. The data related to IBS symptoms, quality of life (QoL), microbiome diversity, and stool short-chain fatty acids were extracted. A random-effect (if RCTs ≥ 6) or fixed-effect model (if RCTs < 5) was used to recalculate effect sizes and 95% CIs and report them in both qualitative and quantitative terms (pooled risk ratio, Hedges' g, and weighted mean difference). A total of 658 articles were initially identified, with 11 meta-analyses and 24 RCTs reporting 28 outcomes with 1646 participants included. An LFD significantly affected the clinical improvement of total symptoms according to the IBS-SSS questionnaire (RR: 1.42; 95% CI: 1.02, 1.97; P = 0.04) in all the subtypes of IBS and also had favorable effects on stool consistency (WMD: -0.48; 95% CI: -0.902, -0.07) and frequency (WMD: -0.36; 95% CI: -0.61, -0.10) and some other GI symptoms in both less and more than 4 weeks of diet intervention except for stool consistency, which needed more than 4 weeks of LFD implementation. A significant QoL improvement was observed but not in the anxiety and depression state. Furthermore, some studies showed that an LFD may increase fecal pH and dysbiosis and reduce SCFA and the abundance of Bifidobacterium. In conclusion, an LFD can alleviate symptoms and QoL in IBS patients, although dysbiosis may occur. Considering the low certainty of evidence, strong RCTs with more appropriate designs are needed.

Muscle Strength and Biochemical Markers as Predictors of Depression in Hemodialysis Patients: A Cross-Sectional Study.

Patients with chronic renal failure, many of which treated with hemodialysis, present a high prevalence of impaired muscle strength which suggest that muscle mass parameters may be used as markers for changes in muscle in these patients. Measurement of handgrip strength (HGS) is a common, simple, and quick measure of muscle function an indicator of overall muscle strength which has been associated with physical activity and several anthropometric traits. Intercellular adhesion molecule-1 (ICAM-1) and insulin-like growth factor-1 (IGF-1) are biochemical markers associated with inflammatory processes which are a common consequence of dialysis. Additionally, hemodialysis patients frequently present signs of malnutrition and depression. This cross-sectional study aimed to evaluate if muscle and biochemical markers could be used to predict the risk of depression in hemodialysis patients. Several anthropometric parameters, nutrient intake, depression state and the serum levels of ICAM-1 and IGF-1 were determined and Pearson's correlation coefficient and/or Spearman's correlation coefficient were used to test the correlation between them. Our results do not show a correlation between HGF, IGF-1 and ICAM-1 with the depression status of the patients, but mid-arm muscle circumference (MAMC) was statistically and positively correlated with depression. Additionally, ICAM-1 levels were negatively correlated with HGS, MAMC, and IGF-1. Overall, the results of the present study suggest that HGS may be used as an indicator of cardiovascular diseases and MAMC may be a good predictor of the level of depression in hemodialysis patients, although further studies are required.

Ellagic acid effects on disease severity, levels of cytokines and T-bet, RORγt, and GATA3 genes expression in multiple sclerosis patients: a multicentral-triple blind randomized clinical trial.

Background: Multiple sclerosis (MS) is a chronic autoimmune disease. Ellagic acid is a natural polyphenol and affects the fate of neurons through its anti-inflammatory and antioxidant properties. The present study aimed to investigate ellagic acid effects on disease severity, the expression of involved genes in the pathogenesis of MS, and the levels of related cytokines. Methods: The present study was a triple-blind clinical trial. Eligible patients were randomly assigned to two groups: Ellagic acid (25 subjects) for 12 weeks, receiving 180 mg of Ellagic acid (Axenic, Australia) and the control group (25 subjects) receiving a placebo, before the main meals. Before and after the study, the data including general information, foods intake, physical activity, anthropometric data, expanded disability status scale (EDSS), general health questionnaire (GHQ) and pain rating index (PRI), fatigue severity scale (FSS) were assessed, as well as serum levels of interferon-gamma (IFNγ), interleukin-17 (IL-17), interleukin-4 (IL-4) and transforming growth factor-beta (TGF-ß), nitric-oxide (NO) using enzyme-linked immunoassay (ELISA) method and expression of T-box transcription factor (Tbet), GATA Binding Protein 3 (GATA3), retinoic acid-related orphan receptor-γt (RORγt) and Glyceraldehyde-3-phosphate dehydrogenase (GAPDH) genes were determined using Real-Time Quantitative Reverse Transcription PCR (RT-qPCR) method. Findings: Ellagic acid supplementation led to a reduction in IFNγ, IL-17, NO and increased IL-4 in the ellagic acid group, however in the placebo group no such changes were observed (-24.52 ± 3.79 vs. -0.05 ± 0.02, p < 0.01; -5.37 ± 0.92 vs. 2.03 ± 1.03, p < 0.01; -18.03 ± 1.02 vs. -0.06 ± 0.05, p < 0.01, 14.69 ± 0.47 vs. -0.09 ± 0.14, p < 0.01, respectively). Ellagic acid supplementation had no effect on TGF-ß in any of the study groups (p > 0.05). Also, the Tbet and RORγt genes expression decreased, and the GATA3 gene expression in the group receiving ellagic acid compared to control group significantly increased (0.52 ± 0.29 vs. 1.51 ± 0.18, p < 0.01, 0.49 ± 0.18 vs. 1.38 ± 0.14, p < 0.01, 1.71 ± 0.39 vs. 0.27 ± 0.10, p < 0.01). Also, ellagic acid supplementation led to significant decrease in EDSS, FSS and GHQ scores (p < 0.05), and no significant changes observed in PRI score (p > 0.05). Conclusion: Ellagic acid supplementation can improve the health status of MS patients by reduction of the inflammatory cytokines and Tbet and RORγt gene expression, and increment of anti-inflammatory cytokines and GATA3 gene expression.Clinical trial registration: (https://en.irct.ir/trial/53020), IRCT20120415009472N22.

The effects of Ellagic acid supplementation on neurotrophic, inflammation, and oxidative stress factors, and indoleamine 2, 3-dioxygenase gene expression in multiple sclerosis patients with mild to moderate depressive symptoms: A randomized, triple-blind, placebo-controlled trial.

BACKGROUND: Depression is one of the most common psychological disorders among multiple sclerosis (MS) patients that characterized as the first symptoms. Ellagic acid is a natural polyphenol that may have neuroprotective properties through antioxidant, anti-inflammatory, and immunomodulatory effects. PURPOSE: The aim of the present study was to investigate the effects of Ellagic acid on circulating levels of brain derived neurotrophic factor (BDNF), interferon-γ (IFN-Æ´), nitric oxide (NO), nuclear factor erythroid-2-related factor 2 (Nrf2), cortisol, serotonergic system, and indoleamine 2, 3-dioxygenase (IDO) gene expression in MS patients with mild to moderate depressive symptoms. STUDY DESIGN: A randomized triple-blind clinical trial. METHODS: The eligible patients according to the inclusion criteria were randomly divided into two groups: either 180 mg Ellagic acid (Axenic company) (n = 25) or 180 mg maltodextrin (n = 25) group for 12 weeks. The Ellagic acid supplement were identical to placebo in shape, color and odor. Serum BDNF, NO, Nrf2, cortisol, serotonin, and IFN-Æ´ were measured by ELISA kit in the baseline and end of the study. Also, demographic characteristics, anthropometric measurements, physical activity, food intake, Beck Depression Inventory-II (BDI-II) and expanding disability status scale (EDSS) questionnaires, as well as IDO gene expression were assessed. SPSS software version 24 was used for statistical analysis. RESULTS: Fifty patients were evaluated, and a significant decrease in BDI-II (p = 0.001), IFN-Æ´ (p = 0.001), NO (p = 0.004), cortisol (p = 0.015), IDO gene expression (p = 0.001) and as well as increased the level of BDNF (p = 0.006) and serotonin (p = 0.019) was observed among those who received 90 mg Ellagic acid twice a day for 12 weeks versus control group. However, there were no significant differences between groups for Nrf2 levels (p>0.05) at the end of study. CONCLUSION: The current study indicates that Ellagic acid intervention has a favorable effect on depression in MS patients. This is achieved by reducing BDI-II scores, as well as levels of NO, cortisol, IFN-Æ´, and IDO gene expression. Furthermore, we found a significant elevation in circulating levels of BDNF and serotonin.

Effects of berberine and barberry on selected inflammatory biomarkers in adults: A systematic review and dose-response meta-analysis of randomized clinical trials.

The previous meta-analysis showed an advantageous effect of berberine supplementation on interleukin 6 (IL-6), tumor necrosis factor-α (TNF-α), and serum C-reactive protein (CRP) concentrations; however, it is unknown the dosage that this component influences inflammatory biomarkers. A comprehensive search was done in Scopus, PubMed, and Web of Science until September 2022 to find randomized controlled trials (RCT) that assessed the effects of berberine/barberry on IL-6, TNF-α, and CRP in adults but not trials without a control group. Studies bias was assessed using RoB 2. A random-effects model was performed to calculate the weighted mean difference (WMD). A dose-dependent effect was calculated. Eighteen clinical trials with 1600 participants were included in the current meta-analysis. These interventions significantly mitigate IL-6 levels (-1.18 pg/mL), TNF-α levels (-3.72 pg/mL), and CRP levels (-1.33 mg/L). In addition, the non-linear analysis showed a significant lowering effect of berberine/barberry on IL-6 and TNF-α levels in doses <1000 mg/day and less than 5 weeks of intervention. There are limitations to our findings, including low-quality studies and significant heterogeneity. These interventions might be considered adjunct therapy to managing inflammation status. However, more investigation and high-quality evidence must be conducted to obtain more comprehensive and generalizable results.

The effects of synbiotics supplementation on reducing chemotherapy-induced side effects in women with breast cancer: a randomized placebo-controlled double-blind clinical trial.

BACKGROUND: The prevalence of breast cancer and its mortality rate are increasing rapidly among women worldwide. On other hand, the courses of chemotherapy as the main treatment for these patients are too much exhaustive and annoying. This study was designed to evaluate the use of synbiotics (probiotics + prebiotics) supplementation as a safe and inexpensive adjuvant treatment in reducing common chemotherapy side effects in women with breast cancer. METHODS: The current study was conducted on 67 women with definitive diagnosis of breast cancer who were hospitalized to receive one-day chemotherapy sessions, and met the inclusion criteria. The patients were randomly allocated to the intervention or control group to receive synbiotics or placebo, respectively. They received oral consumption of synbiotics supplements twice a day for 8 weeks. The primary outcome was the changes in severity or experience of chemotherapy complication, analyzed by intention to treat (ITT). The instruments included 7 validated questionnaires which were used to assess chemotherapy complications in the initiation, 4 weeks and 8 weeks after intervention. Dietary intake was measured by 24-h dietary recall at the beginning, week 4 and week 8. Data were analyzed by SPSS software version 24. P-value < 0.05 was considered as statistically significant. RESULTS: 67 breast cancer patients participated in the study. 8 weeks after intervention and adjusting the confounders, the severity of chemotherapy complications including unnormal defecation (P = 0.005) and fatigue (P < 0/001) decreased significantly in the synbiotics group compared to the placebo group. Furthermore, nausea/vomiting (P = 0.015), and anorexia (P < 0.001) were decreased at the end of the study compared to the first visit, but it was not statistically significant compared to the placebo group. CONCLUSIONS: Synbiotics supplementation during chemotherapy can potentially reduce the severity of fatigue and abnormal defecation. It can help reduce anorexia and nausea/vomiting. TRIAL REGISTRATION: This study was registered in the Iranian Registry of Clinical Trials (IRCT) (registered code: IRCT20091114002709N56) (date of registration: 5/5/2021). Direct link to the trial page: https://www.irct.ir/trial/54559 .

Dietary intake of phytochemicals in association with irritable bowel syndrome in adults.

BACKGROUND & AIM: There is limited data regarding the association between phytochemical-rich diets and irritable bowel syndrome (IBS). The current study aimed to cross-sectionally evaluate the association of dietary phytochemical index (DPI) with the odds and severity of IBS. METHODS: In this study, which included 3362 Iranian healthcare staffs, a dish-based semi-quantitative food frequency questionnaire (DS-FFQ) was utilized to collect dietary information. The DPI was defined as the daily percentage of calories consumed from phytochemical-rich foods. The IBS assessment was performed using a revised Iranian version of the Rome III questionnaire. We applied the restricted cubic spline (RCS) to detect the possible non-linear dependency of the relationship between DPI and the odds of IBS. RESULTS: The mean age, Body Mass Index (BMI), and DPI scores of the participants were 36.29 ± 7.8 years, 24.90 ± 3.8 kg/m2, and 16.07 ± 9.01, respectively. After adjusting for possible confounders, no significant association was observed between DPI and odds of IBS in the whole study population or in gender- and BMI-stratified analyses. We found a significant inverse association between DPI and IBS severity in the study population (OR: 0.70; 95% CI: 0.51-0.98). Concerning gender, such an association was only found in women (OR: 0.65; 95% CI: 0.44-0.96). However, there was no significant relationship between DPI and IBS severity in BMI subgroups. In addition, we found no meaningful relationship between DPI and IBS subtypes. The RCS model showed that there is no non-linear relationship between DPI classification and IBS (non-linear test, χ2 = 1.14, Pnon-linearity = 0.513). CONCLUSIONS: Higher phytochemical intake was associated with reduced IBS severity, particularly in women. Further prospective studies are required to confirm these findings.

Is there any hepatic impact associated with rice bran arabinoxylan compound supplementation? A systematic review and dose-response meta-analysis of randomized controlled trials.

BACKGROUND & AIMS: Rice Bran Arabinoxylan Compound (RBAC) results from an enzymatic modification of rice bran, which is reported to have immunomodulatory, anti-oxidant, and anti-inflammatory effects by regulating the production of pro-inflammatory cytokines. The current systematic review and meta-analysis aimed to determine the hepatic adverse effects of RBAC by assessing the effect through liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST). METHODS: In the present study, the Medline (PubMed), Web of Sciences, and Scopus databases were searched for relevant publications from the beginning to October 2022. The meta-analysis was based on the Mixed effect model to generate the mean effect sizes in weighted mean differences (WMD) and the 95% confidence intervals (95%CI). The heterogeneity was assessed using the Cochrane Chi-squared test, and the analysis of Galbraith plots was applied. RESULTS: Subgroup meta-analysis on five eligible randomized controlled trials (n = 239) showed a significant decrease in serum AST regarding RBAC supplementation in powder form (WMD (95%CI) = -3.52 (-5.62, -1.42) U/L; P-value = 0.001, I2 (%) = 46.9; P heterogeneity = 0.170), three months and more supplementation duration (WMD (95%CI) = -3.71 (-5.95, -1.48) U/L; P-value = 0.001, I2 (%) = 29.9; P heterogeneity = 0.240) and studies with a good quality (WMD (95%CI) = -3.52 (-5.62, -1.42) U/L; P-value = 0.001, I2 (%) = 46.9; P heterogeneity = 0.170). CONCLUSIONS: In conclusion, RBAC supplementation seems to not have any hepatic adverse effects and its supplementation as powder or for three months and more may decrease serum AST levels. However, we need further studies to confirm the results. REGISTRY NUMBER FOR SYSTEMATIC REVIEWS OR META-ANALYZES: CRD42022361002, registration time: 29/09/2022.

Theobromine supplementation in combination with a low-calorie diet improves cardiovascular risk factors in overweight and obese subjects with metabolic syndrome: a randomized controlled trial.

Background & aims: The beneficial effects of theobromine (TB) on obesity and features of metabolic syndrome (MetS) have been reported in several studies. However, the findings are equivocal. The present study aimed to investigate the effects of 12 week pure TB supplementation (450 mg day-1) combined with a low-calorie diet on the anthropometric and metabolic syndrome indices in overweight and obese adults with MetS. Methods: In a randomized double-blind parallel controlled trial, 80 participants aged 40-55 years were randomly assigned to take 450 mg day-1 TB or placebo along with a low-calorie diet for 12 weeks. Dietary intake, anthropometric indices, blood pressure, lipid profile and glycemic indices were assessed at the start and end of the intervention. Results: Seventy-two participants completed the study. After 12 weeks, TB supplementation significantly decreased the waist circumference (WC) (-0.86 cm; P = 0.045), LDL-c/HDL-c (-0.26; P = 0.008), TG/HDL-c (-0.41; P = 0.001), TC/HDL-c (-0.38; P = 0.006) and increased HDL-c (1.72 mg dl-1; P = 0.036) compared to the placebo group. There were no significant differences regarding body weight, BMI, hip circumference (HC), hip-to-waist circumference ratio (WHR), systolic and diastolic blood pressure, fasting levels of total cholesterol (TC), triacylglycerol (TAG), low-density lipoprotein cholesterol (LDL-c), fasting blood glucose, insulin, homoeostatic model assessment for insulin resistance (HOMA-IR) and homeostasis model assessment of ß-cell function (HOMA-ß) between the two groups (p > 0.05). Conclusion: The results of the current study revealed that TB supplementation along with a low-calorie diet had favorable effects on WC, LDL-c/HDL-c, TG/HDL-c, TC/HDL-c, and serum level of HDL-c in overweight and obese subjects with MetS. Trial registration number: IRCT20091114002709N59. Registration date: 5 March 2022.

The effect of pomegranate consumption on cardiovascular risk factors in hemodialysis patients: A systematic review of clinical trials.

Patients undergoing maintenance dialysis have a significantly higher incidence of cardiovascular disease (CVD) compared with the general population. CVD is the most common cause of morbidity and mortality among hemodialysis patients, and has been attributed, among other causes, to increased oxidative stress, inflammation, hypertension and dyslipidemia. Pomegranate, a popular fruit worldwide, has demonstrated health benefits such as antioxidative, antidiabetic, antihypertensive, antihyperlipidemic and anti-inflammatory effects. In this systematic review of clinical trials, we aim to summarize the effect of different parts of pomegranate and the effects of its use on CVD risk factors in hemodialysis patients. PubMed/MEDLINE, EMBASE, Scopus, and Web of Science were searched to identify eligible clinical trials up to December 2021. Ultimately, seven clinical trials were included in this study. Different parts of pomegranate used in these trials were pomegranate juice, pomegranate extract and pomegranate peel extract. The duration of the studies varied from one dialysis session to 1 year. Our results showed that different parts of pomegranate may have anti-hypertensive, antioxidant, anti-inflammatory effects and improve lipid profile by decreasing TG (triglycerides) and increasing HDL-C (high-density lipoprotein cholesterol) in hemodialysis patients. However, due to limited number of studies, more clinical trials need to be performed.

The effect of selenium supplementation on disease activity and immune-inflammatory biomarkers in patients with mild-to-moderate ulcerative colitis: a randomized, double-blind, placebo-controlled clinical trial.

PURPOSE: Selenium (Se) supplementation may help reduce inflammation and disease activity in ulcerative colitis (UC) patients. We investigated the therapeutic effects of Se administration in cases with mild-to-moderate active UC. METHODS: A multicenter, double-blind, randomized clinical trial (RCT) was conducted on 100 cases with active mild-to-moderate UC. The patients were randomly allocated to be given an oral selenomethionine capsule (200 mcg/day, n = 50) or a placebo capsule (n = 50) for 10 weeks. The primary outcome was defined as disease activity via the Simple Clinical Colitis Activity Index (SCCAI), and secondary outcomes were measured at the end of the study. RESULTS: After 10 weeks, the SCCAI score's mean was reduced in the Se group (P < 0.001). At the end of the intervention, clinical improvement (decline of 3 ≥ score from baseline score) was observed in 19 patients (38%) of the Se group and 3 patients (6%) of the placebo group. The patients with clinical remission (defined as SCCAI ≤ 2) were assigned in the Se group (P = 0.014). The Se group's quality of life and Se serum levels were enhanced at the end of the study (P < 0/001). In the Se group, the mean concentration of interleukin-17 decreased (P < 0/001). However, the levels of interleukin-10 showed no considerable change between the two groups in the 10th week (P = 0.23). CONCLUSION: Se supplementation as add-on therapy with medical management induced remission and improved the quality of life in patients with active mild-to-moderate UC. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: IRCT20091114002709N51; 2020-04-13.

A comprehensive insight into the molecular effect of theobromine on cardiovascular-related risk factors: A systematic review of in vitro and in vivo studies.

Theobromine may have beneficial effects on cardiovascular risk factors. This study aimed to find molecular effects of theobromine on lipid profile, glycemic status, inflammatory factors, and vascular function through a comprehensive assessment of all in vitro and in vivo studies. The search process was started at 18 July 2022. Databases including PubMed, Scopus, and Web of Science were searched to find all articles published up to 18 July 2022. Nineteen studies were included in this study. In vitro studies showed the improving effects of theobromine on inflammatory markers. Of four animal studies assessing the effect of theobromine on inflammatory markers, two reported favorable effects. Among five animal studies assessing the effects of theobromine on lipid profile, three reported improving effects on either triglyceride, total cholesterol, low- or high-density lipoprotein cholesterol. Of the three human studies, two revealed that theobromine had improving effects on lipid profile. A favorable effect of theobromine on augmentation index was also reported in two RCTs. The results for other outcomes were inconclusive. Theobromine may have favorable effects on inflammatory factors, lipid profile, and vascular function markers. However, studies with a longer duration and lower, dietary-relevant doses are required for future confirmation.

Comparison of predictive effect of the dietary inflammatory index and empirically derived food-based dietary inflammatory index on the menopause-specific quality of life and its complications.

INTRODUCTION: Menopause, defined as the cessation of menstruation for at least 12 months, is one of the important stages of a woman's life cycle. Some hormonal variations occur during the transition to menopause, which affects women's quality of life. Recently, the role of dietary factors in alleviating symptoms has been investigated. AIM OF THIS STUDY: We tried to investigate the relationship between dietary inflammatory index (DII), food-based dietary inflammatory index (FDII) and quality of life, and menopausal symptoms, comparing their predictive power and suggesting the best cut-off point. METHODOLOGY: One hundred forty-nine postmenopausal women were included in the cross-sectional study. After collecting data by interview, the desired variables were calculated. Logistic regression and ROC curves were used to investigate the relationship and predictive power of DII and FDII with menopausal symptoms. FINDINGS: We observed that both DII and FDII were significantly associated with the severity of sexual symptoms. The first tertile of DII (OR = 0.252, P-value = 0.002) and FDII (OR = 0.316, P-value = 0.014) had a significantly lower odds ratio for severe to moderate symptoms compared to the third tertile. Both inflammatory indices had significant predictive power in predicting the probability of having severe to moderate poor quality of life (FDII (p-value = 0.004) > DII (p-value = 0.006)) and sexual symptoms (DII (p-value = 0.002) > FDII (p-value = 0.003)). Also, regarding the physical subtype, only FDII (p-value = 0.002) results were significant. CONCLUSION: Both dietary inflammatory indices appear to be suitable for predicting quality of life, but FDII had slightly more predictive power. It seems that the quality of life and severity of menopausal symptoms may be improved, particularly with regard to sexual symptoms, by following an anti-inflammatory diet.