The effects of time-restricted eating alone or in combination with probiotic supplementation in comparison with a calorie-restricted diet on endocrine and metabolic profiles in women with polycystic ovary syndrome: A randomized clinical trial.

AIM: To assess the impact of intermittent fasting, with or without probiotic supplementation, versus a calorie-restricted diet on anthropometric measures, metabolic status and gonadal variables in women with polycystic ovary syndrome (PCOS). METHODS: This is a randomized, placebo-controlled, parallel-arm clinical trial. The effects of the 14:10 early time-restricted eating (eTRE) strategy alone or combined with probiotics, on obese women with PCOS, were investigated. Participants were divided into three groups: eTRE plus probiotics (n = 30), eTRE plus placebo (n = 30) and a control group following a standard three-meal-per-day diet with daily calorie restriction (DCR) (n = 30). Over 8 weeks, various anthropometric, metabolic, menstrual and gonadal variables were assessed. RESULTS: A total of 90 individuals were included in the study, with a mean body weight of 81.4 kg, and a mean age of 30 years. Mean (standard deviation) weight loss was not different between the groups at week 8 (TRE + probiotic: -2.2 [1.6] kg vs. TRE + placebo: -2.9 [2.7] kg vs. DCR: -2.5 [1.7] kg). Results revealed that, while all three regimes led to reductions in body weight, body mass index, vascular risk indicators, hirsutism and acne scores, there were no statistically significant differences between the eTRE groups and the control group in terms of weight loss, or improvements in metabolic, menstrual and gonadal variables (P > .05). Additionally, combining probiotics with eTRE did not benefit hormonal and cardiometabolic factors (P > .05). CONCLUSIONS: The eTRE alone or eTRE plus probiotics did not result in significantly greater weight loss or improvements in metabolic, menstrual and gonadal variables compared with the standard three-meal DCR diet.

Healthy eating index and risk of diminished ovarian reserve: a case-control study.

Diminished ovarian reserve (DOR) is associated with reduced fertility and poor reproductive outcomes. The association between dietary patterns and DOR was not well studied. The purpose of this study was to evaluate the relationship between adhering to the healthy eating index (HEI-2015) and the risk of DOR. In this case-control study, 370 Iranian women (120 with DOR and 250 age- and BMI-matched controls) were examined. A reliable semi-quantitative food frequency questionnaire was used to collect diet-related data. We analyzed the HEI-2015 and their dietary intake data to determine major dietary patterns. The multivariable logistic regression was used in order to analyze the association between HEI-2015 and risk of DOR. We found no significant association between HEI-2015 score and risk of DOR in the unadjusted model (OR 0.78; 95%CI 0.59, 1.03). After controlling for physical activity and energy intake, we observed that women in the highest quartile of the HEI-2015 score had 31% decreased odds of DOR (OR 0.69; 95%CI 0.46, 0.93). This association remained significant even after adjusting for all potential confounders. Overall, increased adherence to HEI may lead to a significant reduction in the odds ratio of DOR. Clinical trials and prospective studies are needed to confirm this association.

Dose-dependent effect of megestrol acetate supplementation in cancer patients with anorexia-cachexia syndrome: A meta-analysis.

There is inconsistent evidence relating to the effects of megestrol acetate (MA) supplementation on cancer patients suffering from anorexia-cachexia syndrome. This review aimed to examine the dose-response effect of MA supplementation in patients with cancer-associated anorexia/cachexia. Relevant keywords were searched in PubMed, Scopus and ISI Web of Science from inception to June 2023 for randomized controlled trials (RCTs) examining the effect of MA on pathologies in patients with cancer-associated cachexia. Our primary outcomes were changes in body weight and appetite. However, fatigue and quality of life were secondary outcomes. The mean difference (MD) and 95% confidence interval (95% CI) were estimated using the random-effects method. Thirteen trials comprising 1229 participants (mean age 60 years) were identified. The results of our highest versus lowest analysis revealed that MA supplementation was not associated with any increase in body weight (MD: 0.64 kg, 95% CI [-0.11, 1.38], P = 0.093, I2 = 69.1%; GRADE = very low certainty). Twelve trials, including 14 effect sizes derived from 1369 patients (intervention = 689, control = 680), provided data on the effect of MA on body weight. Subgroup analyses showed a significant increase in body weight following short-term intervention (≤8 weeks) and a combination of radiation/chemotherapy as concurrent treatment. A linear dose-response meta-analysis indicated that each 200 mg/day increment in MA consumption had a significant increase in weight gain (MD: 0.44; 95% CI [0.13, 0.74], P = 0.005; I2 = 97.1%); however, the magnitude of the effect was small. MA administration significantly affected the quality of life based on pooled effect sizes (MD: 1.15, 95% CI [0.76, 1.54], P < 0.001, I2 = 0%; n = 2 RCTs including 176 patients; GRADE = very low certainty). However, no significant effect of MA supplementation was observed on appetite (MD: 0.29, 95% CI [-0.05, 0.64], P = 0.096, I2 = 18.3%; n = 3 RCTs including 163 patients; GRADE = very low certainty) and fatigue (MD: 0.14, 95% CI [-0.09, 0.36], P = 0.236, I2 = 0%; n = 2 RCTs including 300 patients; GRADE = very low certainty). With very low certainty of the evidence, MA supplementation may not lead to a significantly increased weight gain and other outcomes.

The association between ultra-processed food and common pregnancy adverse outcomes: a dose-response systematic review and meta-analysis.

OBJECTIVES: Given the increasing incidence of negative outcomes during pregnancy, our research team conducted a dose-response systematic review and meta-analysis to investigate the relationship between ultra-processed foods (UPFs) consumption and common adverse pregnancy outcomes including gestational diabetes mellitus (GDM), preeclampsia (PE), preterm birth (PTB), low birth weight (LBW), and small for gestational age (SGA) infants. UPFs are described as formulations of food substances often modified by chemical processes and then assembled into ready-to-consume hyper-palatable food and drink products using flavors, colors, emulsifiers, and other cosmetic additives. Examples include savory snacks, reconstituted meat products, frozen meals that have already been made, and soft drinks. METHODS: A comprehensive search was performed using the Scopus, PubMed, and Web of Science databases up to December 2023. We pooled relative risk (RR) and 95% confidence intervals (CI) using a random-effects model. RESULTS: Our analysis (encompassing 54 studies with 552,686 individuals) revealed a significant association between UPFs intake and increased risks of GDM (RR = 1.19; 95% CI: 1.10, 1.27; I2 = 77.5%; p < 0.001; studies = 44; number of participants = 180,824), PE (RR = 1.28; 95% CI: 1.03, 1.59; I2 = 80.0%; p = 0.025; studies = 12; number of participants = 54,955), while no significant relationships were found for PTB, LBW and SGA infants. Importantly, a 100 g increment in UPFs intake was related to a 27% increase in GDM risk (RR = 1.27; 95% CI: 1.07, 1.51; I2 = 81.0%; p = 0.007; studies = 9; number of participants = 39,812). The non-linear dose-response analysis further indicated a positive, non-linear relationship between UPFs intake and GDM risk Pnonlinearity = 0.034, Pdose-response = 0.034), although no such relationship was observed for PE (Pnonlinearity = 0.696, Pdose-response = 0.812). CONCLUSION: In summary, both prior to and during pregnancy, chronic and excessive intake of UPFs is associated with an increased risk of GDM and PE. However, further observational studies, particularly among diverse ethnic groups with precise UPFs consumption measurement tools, are imperative for a more comprehensive understanding.

The association of ultra-processed food intake with neurodegenerative disorders: a systematic review and dose-response meta-analysis of large-scale cohorts.

OBJECTIVES: Our systematic review and meta-analysis aimed to uncover the relationship between UPFs intake and neurodegenerative disorders, including multiple sclerosis (MS), Parkinson's disease (PD), Alzheimer's disease (AD), cognitive impairment, and dementia. SETTING: A systematic search was conducted using the Scopus, PubMed/MEDLINE, and ISI Web of Science databases without any limitation until June 24, 2023. Relative risk (RR) and 95% confidence interval (CI) were pooled by using a random-effects model, while validated methods examined quality and publication bias via Newcastle-Ottawa Scale, Egger's regression asymmetry, and Begg's rank correlation tests, respectively. RESULTS: Analysis from 28 studies indicated that a higher UPFs intake was significantly related to an enhanced risk of MS (RR = 1.15; 95% CI: 1.00, 1.33; I2 = 37.5%; p = 0.050; n = 14), PD (RR = 1.56; 95% CI: 1.21, 2.02; I2 = 64.1%; p = 0.001; n = 15), and cognitive impairment (RR = 1.17; 95% CI: 1.06, 1.30; I2 = 74.1%; p = 0.003; n = 17), although not AD or dementia. We observed that a 25 g increment in UPFs intake was related to a 4% higher risk of MS (RR = 1.04; 95% CI: 1.01, 1.06; I2 = 0.0%; p = 0.013; n = 7), but not PD. The non-linear dose-response relationship indicated a positive non-linear association between UPF intake and the risk of MS (Pnonlinearity = 0.031, Pdose-response = 0.002). This association was not observed for the risk of PD (Pnonlinearity = 0.431, Pdose-response = 0.231). CONCLUSION: These findings indicate that persistent overconsumption of UPFs may have an adverse impact on neurodegenerative conditions, potentially leading to a decline in quality of life and reduced independence as individuals age.

Dietary fat intake with risk of gestational diabetes mellitus and preeclampsia: a systematic review and meta-analysis of prospective cohort studies.

CONTEXT: Gestational diabetes mellitus (GDM) and preeclampsia (PE) are commonly observed medical complications in pregnancy. Dietary total fat and fatty acids associated with GDM and PE risk have been examined in several epidemiological studies. In some instances, systematic reviews and meta-analyses might provide more accurate dietary recommendations. OBJECTIVES: This systematic review and dose-response meta-analysis was conducted to investigate the association between dietary total fat and fatty acids and the risk of GDM and PE. DATA SOURCES: Research on dietary fat intake and the risk of GDM and PE was conducted through systematic searches of the PubMed, Scopus, and Web of Science databases for articles published up to August 19, 2023. An investigation of associations between dietary intake of total fat and fatty acids and the risk of GDM and PE was performed using prospective cohort study designs. RESULTS: Twenty-one prospective cohort studies were considered eligible. Findings indicated that higher intakes of total fat (relative risk [RR], 1.08; 95% confidence interval [CI], 1.02-1.14), animal fat (RR, 1.56; 95%CI, 1.34-1.89), vegetable fat (RR, 1.23; 95%CI, 1.05-1.45), dietary cholesterol (RR, 1.48; 95%CI, 1.10-2.00), and omega-3 fatty acid (RR, 1.11; 95%CI, 1.02-1.20) are associated with a greater risk of GDM. However, no significant association was found between dietary total fat and fatty acids and the risk of PE. Dose-response meta-analyses suggested every 10% increment in total energy intake from total fat, 5% from animal fat, 5% from vegetable fat, and 100 mg from cholesterol was related to 15%, 12%, 7%, 14%, and 20% higher GDM risk, respectively. CONCLUSIONS: Overall, total fat, animal fat, vegetable fat, dietary cholesterol, and omega-3 fatty acid consumption are associated with a small but statistically significant increase in GDM risk. PROTOCOL REGISTRATION: PROSPERO (CRD42023466844).

The effects of citrus flavonoids supplementation on endothelial function: A systematic review and dose-response meta-analysis of randomized clinical trials.

The present systematic review and dose-response meta-analysis was conducted to synthesize existing data from randomized clinical trials (RCTs) concerning the impact of citrus flavonoids supplementation (CFS) on endothelial function. Relevant RCTs were identified through comprehensive searches of the PubMed, ISI Web of Science, and Scopus databases up to May 30, 2023. Weighted mean differences and their corresponding 95% confidence intervals (CI) were pooled utilizing a random-effects model. A total of eight eligible RCTs, comprising 596 participants, were included in the analysis. The pooled data demonstrated a statistically significant augmentation in flow-mediated vasodilation (FMD) (2.75%; 95% CI: 1.29, 4.20; I2 = 87.3%; p < 0.001) associated with CFS compared to the placebo group. Furthermore, the linear dose-response analysis indicated that each increment of 200 mg/d in CFS led to an increase of 1.09% in FMD (95% CI: 0.70, 1.48; I2 = 94.5%; p < 0.001). The findings from the nonlinear dose-response analysis also revealed a linear relationship between CFS and FMD (Pnon-linearity = 0.903, Pdose-response <0.001). Our findings suggest that CFS enhances endothelial function. However, more extensive RTCs encompassing longer intervention durations and different populations are warranted to establish more precise conclusions.

The effects of coenzyme Q10 supplementation on biomarkers of exercise-induced muscle damage, physical performance, and oxidative stress: A GRADE-assessed systematic review and dose-response meta-analysis of randomized controlled trials.

PURPOSE: This study aims to elucidate the dose-dependent effect of coenzyme Q10 supplementation (CoQ10) on exercise-induced muscle damage (EIMD), physical performance, and oxidative stress in adults. METHODS: A systematic search was conducted through PubMed, Scopus, and ISI Web of Science databases up to August 2023, focusing on randomized control trials (RCTs) that investigated the effects of CoQ10 supplementation on EIMD recovery, physical performance and oxidative stress mitigation in adults. The weighted mean difference (WMD) and 95 % confidence interval (95 %CI) were estimated using the random-effects model. RESULTS: The meta-analysis incorporated 28 RCTs, encompassing 830 subjects. CoQ10 supplementation significantly decreased creatine kinase (CK) (WMD: -50.64 IU/L; 95 %CI: -74.75, -26.53, P < 0.001), lactate dehydrogenase (LDH) (WMD: -52.10 IU/L; 95 %CI: -74.01, -30.19, P < 0.001), myoglobin (Mb) (WMD: -21.77 ng/ml; 95 %CI: -32.59, -10.94, P < 0.001), and Malondialdehyde (MDA) (WMD: -0.73 µmol/l; 95 %CI: -1.26, -0.20, P = 0.007) levels. No significant alteration in total antioxidant capacity was observed post-CoQ10 treatment. Each 100 mg/day increase in CoQ10 supplementation was correlated with a significant reduction in CK (MD: -23.07 IU/L, 95 %CI: -34.27, -11.86), LDH (WMD: -27.21 IU/L, 95 %CI: -28.23, -14.32), Mb (MD: -7.09 ng/ml; 95 %CI: -11.35, -2.83) and MDA (WMD: -0.17 µmol/l, 95 %CI: -0.29, -0.05) serum levels. Using SMD analysis, "very large" effects on LDH and "moderate" effects on CK and MDA were noted, albeit nonsignificant for other outcomes. CONCLUSION: CoQ10 supplementation may be effective in reducing biomarkers of EIMD and oxidative stress in adults. Nevertheless, given the preponderance of studies conducted in Asia, the generalizability of these findings warrants caution. Further RCTs, particularly in non-Asian populations with large sample sizes and extended supplementation durations, are essential to substantiate these observations.

Nutritional interventions for exercise-induced muscle damage: an umbrella review of systematic reviews and meta-analyses of randomized trials.

CONTEXT: Several meta-analyses have been conducted on the effect of nutritional interventions on various factors related to muscle damage. However, the strength of the evidence and its clinical significance are unclear. OBJECTIVES: This umbrella review aimed to provide an evidence-based overview of nutritional interventions for exercise-induced muscle damage (EIMD). DATA SOURCES: PubMed, Scopus, and ISI Web of Science were systematically searched up to May 2022. DATA EXTRACTION: Systematic reviews and meta-analyses of randomized controlled trials investigating nutritional interventions' effects on recovery following EIMD were included. The certainty of the evidence was rated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). RESULTS: Fifty-three randomized controlled trial meta-analyses were included, evaluating 24 nutritional interventions on 10 different outcomes. The results revealed a significant effect of hydroxymethylbutyrate (HMB) supplementation and l-carnitine supplementation for reducing postexercise creatine kinase; HMB supplementation for reducing lactate dehydrogenase; branched-chain amino acids and leaf extract supplementation for reducing the delayed onset of muscle soreness; and l-carnitine, curcumin, ginseng, polyphenols, and anthocyanins for reducing muscle soreness, all with moderate certainty of evidence. CONCLUSIONS: Supplementation with HMB, l-carnitine, branched-chain amino acids, curcumin, ginseng, leaf extract, polyphenols, and anthocyanins showed favorable effects on some EIMD-related outcomes. PROTOCOL REGISTRATION: PROSPERO registration no. CRD42022352565.

Dose-response association between animal protein sources and risk of gestational diabetes mellitus: a systematic review and meta-analysis.

CONTEXT: There are contradictory findings about the relationship between various animal protein sources and the risk of gestational diabetes mellitus (GDM). OBJECTIVE: The purpose of our study was to understand better the associations between total protein, animal protein, and animal protein sources and the risk of developing GDM. DATA SOURCES: A systematic literature search was conducted in PubMed, Scopus, and Web of Science encompassing the literature up until August 2022. A random-effects model was used to combine the data. For estimating the dose-response curves, a one-stage linear mixed-effects meta-analysis was conducted. DATA EXTRACTION: Data related to the association between animal protein consumption and the risk of GDM in the general population was extracted from prospective cohort studies. DATA ANALYSIS: It was determined that 17 prospective cohort studies with a total of 49 120 participants met the eligibility criteria. It was concluded with high certainty of evidence that there was a significant association between dietary animal protein intake and GDM risk (1.94, 95% CI 1.42 to 2.65, n = 6). Moreover, a higher intake of total protein, total meat, and red meat was positively and significantly associated with an increased risk of GDM. The pooled relative risks of GDM were 1.50 (95% CI: 1.16, 1.94; n = 3) for a 30 g/d increment in processed meat, 1.68 (95% CI: 1.25, 2.24; n = 2) and 1.94 (95% CI: 1.41, 2.67; n = 4) for a 100 g/d increment in total and red meat, and 1.21 (95% CI: 1.10, 1.33; n = 4) and 1.32 (95% CI: 1.15, 1.52; n = 3) for a 5% increment in total protein and animal protein, respectively. GDM had a positive linear association with total protein, animal protein, total meat consumption, and red meat consumption, based on non-linear dose-response analysis. CONCLUSION: Overall, consuming more animal protein-rich foods can increase the risk of GDM. The results from the current study need to be validated by other, well-designed prospective studies. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42022352303.

No benefit of soluble fiber on liver function.

Background: To conduct a systematic review and dose-response meta-analysis of current findings from randomized controlled trials (RCTs) on the effect of soluble fiber supplementation on liver function in both healthy individuals and people with specific health conditions, PubMed, Scopus, and ISI Web of Science were systematically searched for relevant RCTs published prior to April 2022. Methods: We estimated the change in liver function parameters for each 5 g/d increment in soluble fiber in each trial and then calculated the mean difference (MD) and 95%CI. A total of 25 RCTs with 27 treatment arms (1744 subjects; 884 cases, 860 controls) were included. Results: A total of 25 RCTs with 27 treatment arms were included. The intervention duration of the included studies ranged from 3 to 52 weeks and the dose of soluble fiber supplementation varied from 0.0025 to 40 g/d. Soluble fiber supplementation could not significantly affect serum alanine transaminase (MD: -0.02 U/L, 95% CI: -1.06 to 1.01), aspartate transaminase (MD: -0.34 U/L, 95% CI: -0.84 to 0.15), alkaline phosphatase (MD: 0.29 U/L, -0.14 to 0.71), gamma-glutamyl transferase (MD: 0.12 U/L; 95% CI: -0.81 to 1.05), serum bilirubin (MD: 0.42µmol/L, 95% CI: -0.08 to 0.93) and albumin (MD: 0.64 g/dl, 95% CI: -0.42 to 1.70) levels. Conclusions: Findings from this study did not support the beneficial effects of soluble fiber supplementation on liver function biomarkers. There is a need for long-term high-quality interventions to examine the effects of different types and doses of soluble fibers on liver function as primary outcome.

The impact of malnutrition on mortality and complications of hematopoietic stem cell transplantation in patients with acute leukemia.

BACKGROUND & AIMS: Malnutrition is common in hematopoietic stem cell transplantation (HSCT) patients. However, there are few studies on the association between malnutrition and post-transplant outcomes, with inconsistent results. No standard screening tool has been established for malnutrition in these patients. Previous research suggests the Global Leadership Initiative on Malnutrition (GLIM) criteria is effective in predicting outcomes in other cancers. This study investigates the link between malnutrition based on the GLIM criteria with mortality and complications following allogeneic HSCT. METHODS: This single-center, observational, longitudinal, and prospective study of 98 adult leukemia patients at the Hematology Center of Shariati Hospital in Tehran, Iran, monitored patients before transplantation until 100 days after the procedure, focusing on overall survival and mortality as a primary outcome, and secondary endpoints including oral mucositis, acute GVHD, infection during hospitalization, and readmission rates. RESULTS: This study involved 98 allogeneic HSCT patients with a median age of 38 years old, 64.3 % with acute myeloid leukemia (AML), and 35.7 % with acute lymphoblastic leukemia (ALL). Among them, 26.5 % were categorized as malnourished based on GLIM criteria. During 100 days of follow-up, 13 patients died, but there was no significant difference in overall survival and mortality between malnourished and well-nourished patients. Malnourished patients demonstrated a noticeable upward trend in the incidence of oral mucositis, hospital readmission, and infection during their hospitalization. It is important to highlight that although this observed trend is discernible, it did not attain statistical significance in statistical analyses (P > 0.05). CONCLUSION: The current study determined that, when assessed using the GLIM criteria, malnutrition did not exert a statistically significant influence on survival, mortality, or complications within the specified age range of 18-55 years, underscoring its limited impact on this cohort of younger patients.

The effects of pro-, pre-, and synbiotics supplementation on polycystic ovary syndrome: an umbrella review of meta-analyses of randomized controlled trials.

Background: Synbiotics, refer to a combination of probiotics and prebiotics in a form of synergism that beneficially affect the host's health by alternating the composition and/or function of the gut microbiota. Numerous meta-analyses of randomized clinical trials have proven that pro, pre-, and synbiotics supplementation has health outcomes in women with polycystic ovary syndrome (PCOS). However, the strength and quality of this evidence in aggregate have not yet been synthesized in great detail. Methods: PubMed, Scopus, Web of Sciences, and Google Scholar were searched up to March 2023. We pooled the mean difference and its 95% confidence interval (CI) by applying a random-effects model. Results: Overall, nine meta-analyses including a total of 12 trials were identified. The results of the present study indicated that probiotic supplementation significantly reduced the homeostatic model assessment for insulin resistance (HOMA-IR; WMD: -0.29, 95% CI: -0.57 to -0.02, p = 0.03, n = 4; moderate certainty) and fasting glucose concentration (FGC; WMD: -7.5 mg/dL, 95% CI: -13.60 to -0.51, p = 0.03; n = 4; low certainty). Moreover, synbiotic supplementation had beneficial effects on glycemic control, lipid profile, and hormonal parameters, but the certainty of the evidence was rated as low to very low. However, supplementation with pro-/synbiotics did not affect inflammation and oxidative stress in women with PCOS. Furthermore, waist/hip circumference, fasting glucose concentration, lipid profile, dehydroepiandrosterone sulfate, high-sensitivity C-reactive protein, and hirsutism score were significantly reduced after prebiotics supplementation with low certainty of evidence. Conclusion: Although pro-, pre-, and synbiotics supplementation had beneficial effects on some PCOS-related outcomes, the certainty of the evidence was rated as low to very low. Therefore, further well-designed RCTs might help to confirm our findings in women with PCOS.

Effect of soluble fiber on blood pressure in adults: a systematic review and dose-response meta-analysis of randomized controlled trials.

OBJECTIVES: Pervious epidemiologic evidence indicates that soluble fiber is protective against hypertention: however, randomized controlled trials (RCTs) have presented varying results. In the present study, we aimed to conduct a systematic review and dose-response meta-analysis to summarize published RCTs which assess the effect of soluble fiber supplementation on systolic blood pressure (SBP) and diastolic blood pressure (DBP). METHODS: Scopus, PubMed, and ISI Web of Sciences were searched to identify relevant studies up to Aug 2022. We estimated the change in blood pressure for each 5 g/d increment in soluble fiber supplementation in each trial and then calculated the weighted mean difference (WMD) and 95%CI using a random-effects model. We estimated dose-dependent effects using a dose-response meta-analysis of differences in means. The risk of bias for study was assessed using the Cochrane tool. Publication bias was evaluated via funnel plot and Begg's test and Egger's test. RESULTS: Eighty-three eligible studies with total sample size of 5,985 participants were included in the meta-analysis. Soluble fiber supplementation significantly decreased SBP (WMD: -1.36 mmHg, 95% CI: -2.13 to -0.60, P < 0.001; I2 = 47.1%, P < 0.001) and DBP (WMD: -0.72 mmHg, 95% CI: -1.26 to -0.18, P = 0.009; I2 = 45.4%, P < 0.001). Each 5 g/d increment in soluble fiber supplementation had a significant reduction in SBP (WMD: -0.54 mmHg; 95%CI: -0.86, -0.22, P = 0.001; I2 = 52.2, Phet < 0.001) and DBP (WMD: -0.28 mmHg; 95%CI: -0.49, -0.80, P = 0.007; I2 = 43.1%, Phet < 0.001). The levels of SBP decreased proportionally with the increase in soluble fiber supplementation up to 20 g/d (MD20g/d: -1.79 mmHg, 95%CI: -2.86, -0.71). CONCLUSION: Current evidence indicated the beneficial effect of soluble fiber supplementation on blood pressure. Our findings suggest that soluble fiber supplementation could contribute to the management of hypertension and the reduction of cardiovascular disease risk.

The effects of intermittent fasting diet alone or in combination with probiotic supplementation in comparison with calorie-restricted diet on metabolic and hormonal profile in patients with polycystic ovary syndrome: study protocol for a randomized clinical trial.

INTRODUCTION: Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in females characterized by ovulatory dysfunction, hyperandrogenism, and other metabolic disorders. Both intermittent fasting and specific probiotics have been suggested to help improve patients with PCOS through changes in gut microbial composition, circadian clock, and metabolic regulation. Therefore, the present study aims to investigate the effects of intermittent fasting alone or in combination with probiotic supplementation compared to the calorie-restricted (CR) diet on anthropometric measures, metabolic status, inflammation, and oxidative stress in women with PCOS. METHODS: We will carry out a randomized clinical trial for 8 weeks. Participants will be randomly assigned (1:1:1) to one of the three groups: (1) a 14:10 early time-restricted feeding (TRF) diet with probiotic supplementation (n = 30); (2) a 14:10 early TRF diet with placebo supplementation (n = 30); (3) a CR diet (energy-restricted 25% of required calories) with placebo supplementation as a control group (n = 30). The primary outcomes will be changes in body weight and insulin resistance. However, glycemic control, lipid profile, metabolic parameters, sex hormone-binding globulin, dehydroepiandrosterone, anti-Mullerian hormone, free androgen index, hirsutism, acne, antioxidant and oxidant status, inflammation, anthropometric measures, mental health, sleep quality, appetite, eating behavior, food craving, and blood pressure are secondary outcomes. All outcomes of this study will be evaluated in pre- and post-intervention. DISCUSSION: We hypothesized that 10-h TRE administered alone or in combination with probiotic supplementation to overweight and obese PCOS subjects would lead to weight loss and improved metabolic, hormonal, inflammatory, and antioxidant markers compared to control subjects following a standard 3-meal-per-day CR diet. ETHICAL ASPECTS: The current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICNE.REC.1401.425). TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20121110011421N5. Registered on 3 October 2022.

The effects of spirulina supplementation on serum iron and ferritin, anemia parameters, and fecal occult blood in adults with ulcerative colitis: A randomized, double-blinded, placebo-controlled trial.

BACKGROUND & AIMS: The present clinical trial aimed to evaluate the efficacy of spirulina administration on serum iron, ferritin, anemia parameters, and fecal occult blood test (FOBT) in adults with ulcerative colitis (UC). METHODS: Eighty participants with UC were randomly assigned to take, either 1 g/day (two 500 mg capsules) spirulina (n = 40) or placebo (n = 40) in a double-blinded clinical trial for eight weeks. Dietary intake, physical activity status, serum iron and ferritin levels, anemia parameters, and FOBT were assessed in each participant at baseline and following the intervention. Seventy-three participants completed the trial. RESULTS: Our results indicated significantly increased (p = 0.04) serum iron after eight weeks of spirulina supplementation compared to the placebo group. The spirulina group also demonstrated significantly increased mean corpuscular volume (p = 0.004) whereas red blood cell count (p = 0.01) and hematocrit (p = 0.03) were significantly lowered in the placebo group. No significant changes in FOBT outcomes were seen between groups at baseline (p = 0.12) and the end of the trial (p = 0.34). Eight weeks of 1 g/day spirulina supplementation improved anemia parameters in adults with UC compared to placebo. CONCLUSIONS: These outcomes suggest that spirulina administration may be beneficial in the management of anemia in UC. Further clinical trials of longer duration are necessary to corroborate and expand our findings. Registered at: http://www.IRCT.ir (code: IRCT20170802035460N3).

The association of ultra-processed food consumption with adult inflammatory bowel disease risk: a systematic review and dose-response meta-analysis of 4 035 694 participants.

CONTEXT: There is an inconsistency between the results obtained from observational studies regarding intake of ultra-processed foods (UPFs) and the risk of inflammatory bowel disease (IBD). OBJECTIVES: A dose-response meta-analysis was performed to evaluate the relationship between UPF intake and the risk of IBD. DATA SOURCES: Searches were performed in the PubMed, ISI Web of Science, and Scopus databases up to November 2, 2022. DATA EXTRACTION: Data were available from 24 studies including a total of 4 035 694 participants from 20 countries. DATA ANALYSIS: Risk ratios for IBD were analyzed by a random-effects model. Outcomes indicated that UPF intake was linked to an increased risk of IBD (relative risk [RR], 1.13; 95%CI, 1.06-1.21; P = 0.001; I2 = 73.2%; n = 59; N = 4 035 694). This association was significant, especially for the risk of Crohn's disease (CD) (RR, 1.19; 95%CI, 1.00-1.41; I2 = 78.2%; P = 0.046; n = 23; N = 2 167 160), unlike the risk of ulcerative colitis (UC) (RR = 1.11; 95%CI, 0.99-1.26; P = 0.085; I2 = 60.3%; n = 27; N = 2 167 918). Also, results revealed that each 10% enhancement in daily UPF intake was not related to the risk of IBD (RR, 1.05; 95%CI, 0.98-1.14; P = 0.168; I2 = 31.9%; n = 4) or the risk of UC (RR, 1.01; 95%CI, 0.92-1.11; P = 0.876; I2 = 34.7%; n = 2) in adults. However, results suggested that for every 10% increase in daily UPF intake, there was a 19% increase in the risk of CD (RR, 1.19; 95%CI, 1.01-1.32; P = 0.021; I2 = 0.0%; n = 2) among adults. In addition, the results showed a positive linear relation between UPF intake with CD risk (Pnonlinearity = 0.431; Pdose response = 0.049) but not risk of IBD or UC. CONCLUSION: High intake of UPFs was linked with an enhanced IBD risk, a specific risk of CD. However, conducting more observational studies among several ethnicities and using specific tools that accurately assess the amount of UPF consumption, components of UPFs, and food additives may be necessary. Systematic Review Registration: PROSPERO registration no. CRD42023390258.

The Association between Total Protein, Animal Protein, and Animal Protein Sources with Risk of Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis of Cohort Studies.

We aimed to conduct this dose-dependent meta-analysis to examine the relation between total protein, animal protein, and its sources with inflammatory bowel disease (IBD). We searched databases, comprising PubMed/Medline, Web of Science (ISI), Embase, and Google Scholar, for the published studies up to 28 March 2023. Prospective cohort study designs that investigated associations between dietary intake of various animal protein sources and with risk of IBD in the general population were identified. Eleven prospective cohort studies with 4,302,554 participants and 8067 cases were considered eligible. Findings indicated that higher intake of dairy was significantly associated with a lower risk of IBD (relative risk [RR]: 0.81; 95% confidence interval [CI]: 0.72, 0.90), Crohn disease (RR: 0.69; 95% CI: 0.56, 0.86), and ulcerative colitis (RR: 0.84; 95% CI: 0.75, 0.94). There was no association between different sources of animal protein and the risk of IBD. The dose-response analysis suggested that each 100 g/d increment in dietary total meat consumption was associated with a 38% greater risk of IBD. Moreover, a positive linear association was found between total meat intake and risk of IBD (Pnonlinearity = 0.522, Pdose-response = 0.005). Overall, among the dietary sources of protein, the risk of IBD increased only with increasing total meat intake, and the consumption of protein from dairy products was found to be a protective factor against the IBD risk. This trial was registered at PROSPERO as CRD42023397719.

The effect of omega-3 fatty acids supplementation on inflammatory biomarkers in subjects with migraine: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: Imbalances in immune regulation are important features of migraine pathophysiology. In line with this, the current study investigated the efficacy of omega-3 fatty acids supplementation on inflammatory and anti-inflammatory markers in patients with migraines. MATERIALS AND METHODS: This randomized, double-blind, placebo-controlled trial consisted of 40 patients that were prone to experiencing episodic migraines. For two months, participants were randomized into one group that received omega-3 supplementation (n= 20), 600 mg of EPA and 300 mg of DHA, twice daily) or another group that received a placebo (n= 20). Transforming growth factor ß (TGF-ß), interleukin (IL)-4, interferon-gamma (IFN-γ), and interleukin (IL)-17 serum levels were assessed using enzyme-linked immunosorbent assay methods at baseline and following the intervention. The current study was registered on ClinicalTrials.gov with the registration number NCT02532023. RESULTS: After two months of intervention, the administration of omega-3 fatty acids resulted in a significant rise in the concentrations of anti-inflammatory cytokine IL-4 (p=0.010) as well as a significant reduction in concentrations of pro-inflammatory cytokine IFN-γ (p=0.001) compared with the placebo. However, no significant changes were observed in serum TGF-ß and IL-17 levels. DISCUSSION: Our findings indicated consumption of omega-3 fatty acids may have a potentially beneficial response on the inflammatory immune response in patients with migraines. Larger trials are needed to corroborate these findings.

Early vs delayed enteral nutrition or parenteral nutrition in hospitalized patients: An umbrella review of systematic reviews and meta-analyses of randomized trials.

We conducted an umbrella review to summarize the existing evidence on the effect of early enteral nutrition (EEN) compared with other approaches, including delayed enteral nutrition (DEN), parenteral nutrition (PN), and oral feeding (OF) on clinical outcomes in hospitalized patients. We performed a systematic search up to December 2021, in MEDLINE (via PubMed), Scopus, and Institute for Scientific Information Web of Science. We included systematic reviews with meta-analyses (SRMAs) of randomized trials investigating EEN compared with DEN, PN, or OF for any clinical outcomes in hospitalized patients. We used "A Measurement Tool to Assess Systematic Reviews" (AMSTAR2) and the Cochrane risk-of-bias tool for assessing the methodological quality of the systematic reviews and their included trial, respectively. The certainty of the evidence was rated using the "Grading of Recommendations Assessment, Development, and Evaluation" (GRADE) approach. We included 45 eligible SRMAs contributing with a total of 103 randomized controlled trials. The overall meta-analyses showed that patients who received EEN had statistically significant beneficial effects on most outcomes compared with any control (ie, DEN, PN, or OF), including mortality, sepsis, overall complications, infection complications, multiorgan failure, anastomotic leakage, length of hospital stay, time to flatus, and serum albumin levels. No statistically significant beneficial effects were found for risk of pneumonia, noninfectious complications, vomiting, wound infection, as well as number of days of ventilation, intensive care unit days, serum protein, and pre-serum albumin levels. Our results indicate that EEN may be preferred over DEN, PN, and OF because of the beneficial effects on many clinical outcomes.