The effect of time-restricted eating on arterial stiffness indices in men with metabolic syndrome: study protocol for a randomized controlled trial.

BACKGROUND: Time-restricted eating (TRE) has been shown to be associated with improvements in some aspects of the metabolic syndrome. Nevertheless, only a few studies have addressed the effect of TRE on pulse wave velocity (PWV). We thus propose a randomized controlled trial to compare the effects of TRE with standard dietary advice on PWV and thereby present the protocol. METHODS: Forty-eight participants will be assigned to either TRE or control groups using simple randomization. The TRE group will consume their meals during a 10-h period and experience 14 h of fasting. They will also be advised to consume their last meal no later than 20:00. Both groups will receive standard dietary advice. The participants will be followed for 6 weeks. The primary outcome will be changes in PWV. Laboratory measurements, including lipid profile, liver enzyme tests, fasting blood glucose (FBG), insulin concentrations, and insulin resistance, as well as anthropometric data, blood pressure, basal metabolic rate, appetite status, physical activity level, sleep quality, cognitive function, quality of life, and calorie intake, will be evaluated throughout the study. DISCUSSION: The outcomes of this study will allow a comparison of the effects of TRE and standard dietary recommendations on PWV and other cardiometabolic factors in individuals with metabolic syndrome (MetS). TRIAL REGISTRATION: Iranian Registry of Clinical Trials; code: IRCT20201230049889N1; registered on August 14, 2022. The registration of the trial is accessible at: https://www.IRCT.ir/trial/64485?revision=281341 .

Effects of sumac supplementation on lipid profile: A systematic review and meta-analysis of randomized controlled trials.

This systematic review aimed to gather data on the effects of sumac supplementation on lipid profile. A systematic literature search was carried out using electronic databases (PubMed, Scopus, and Web of Science) up to March 2023 to identify eligible randomized controlled trials (RCTs) assessing the effects of sumac intake on lipid profile as an outcome. All participants enrolled in our study were adult individuals who consumed sumac, in various forms, as an intervention. The included articles were assessed using the Cochrane risk of bias assessment tool. Heterogeneity tests of the selected trials were performed using the I2 statistic. Random effects models were assessed based on the heterogeneity tests, and pooled data were determined as the weighted mean difference with a 95% confidence interval. In total, seven RCTs with a total sample size of 570 subjects were included. This study found a significant decrease in total cholesterol (TC) (weighted mean difference [WMD]: -10.01 mg/dL; 95% CI: -18.67, -1.34), triglyceride (TG) (WMD: -8.52 mg/dL; 95% CI: -14.79, -2.25), and low-density lipoprotein (LDL)-C levels (WMD: -9.25 mg/dL; 95% CI: -14.56, -3.93); Moreover, a significant increase was observed in high-density lipoprotein (HDL)-C concentration (WMD: 2.97 mg/dL; 95% CI: 0.75, 5.19). The reduction in TG and TC was greater in studies with a duration of ≥12 compared to <12 weeks. The increase in HDL-C was greater in participants with an intervention duration of ≥12 compared to <12 weeks. Moreover, subgroup analysis based on the dose of sumac suggested a significant reduction in TC and LDL, specifically for doses below 3 g. Consumption of sumac significantly decreased serum TC, LDL-C, and TG concentrations. This study suggested significantly positive effects on HDL-C by intake of sumac. Longer interventions (>12 weeks) have a more favorable impact on TC, LDL-C, and HDL-C, while sumac doses below 3 g/day show greater effects on TC and LDL-C. These findings underscore the potential of sumac supplementation as a valuable approach to lipid profile management.

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 Effects of Coenzyme Q10 Supplementation on Oxidative Status and Lipid Profile in Migraine Patients: A Randomized Double-Blinded Controlled Clinical Trial.

Migraine is a common neurological disease correlated with oxidative stress and lipid profile disorders. The present study was designed to determine the effects of Coenzyme Q10 (Co-Q10) supplementation on oxidative status and lipid profile in migraine individuals. This clinical trial was conducted on 84 females aged 18-50 years, diagnosed for episodic migraine according to the International Headache Society. Subjects were randomized to receive either Co-Q10 supplement (400 mg/day) or placebo for 12 weeks. Lipid profile and oxidative stress indices including malondialdehyde (MDA) and total antioxidant capacity (TAC) were measured before and after intervention in both groups. Also, anthropometric indices, dietary intakes, and clinical features were collected. Data analysis was conducted using SPSS version 16. Seventy-seven of the participants, with mean age of 33.70 ± 7.75 years, completed the study. After 12-week intervention, Co-Q10 led to a significant decrease in MDA levels compared to placebo (p = 0.009), with no effect on TAC levels (p = 0.106). A significant increase in serum Co-Q10 concentration and high-density lipoprotein cholesterol (HDL-C) level in Co-Q10 group was observed, but no significant differences were found in other lipid profile variables (low-density lipoprotein cholesterol, triglycerides and total cholesterol). Among anthropometric variables, Co-Q10 only caused a significant reduction in body fat percentage (BFP), but we did not find any significant changes in others. A 12-week Co-Q10 supplementation led to significant improvement in clinical features, BFP, and HDL-C level among migraine individuals. Trial Registration: Iranian Registry of Clinical Trials Identifier: IRCT201508265670N10.

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.

Pomegranate (Punica granatum L.) peel extract ameliorates metabolic syndrome risk factors in patients with non-alcoholic fatty liver disease: a randomized double-blind clinical trial.

INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) is a metabolic syndrome (MS)-related liver disorder that has an increasing prevalence. Thus, the aim of our study is to evaluate the effects of pomegranate peel extract (PP) supplementation on hepatic status and metabolic syndrome risk factors. METHODS: In phase one, the hydro-alcoholic extraction of the peel of 750 kg of pomegranate (Punica granatum L.) was performed by the soaking method. Then, in phase two, NAFLD patients received 1500 mg of placebo (n = 37) or pomegranate peel capsules (n = 39) with a 500-kcal deficit diet for 8 weeks. Gastrointestinal intolerance, dietary intake, lipid and glycemic profiles, systolic and diastolic blood pressure, body composition, insulin resistance indexes, and elastography-evaluated NAFLD changes were followed. RESULTS: The mean age of participants was 43.1 ± 8.6 years (51.3% female). Following the intervention, the mean body weight (mean changes: -5.10 ± 2.30 kg), waist circumference (-7.57 ± 2.97 cm), body mass index (-1.82 ± 0.85 kg/m2), body fat index (-1.49 ± 0.86), and trunk fat (- 3.93 ± 3.07%), systolic (-0.63 ± 0.29 cmHg) and diastolic (-0.39 ± 0.19 cmHg) blood pressure, total cholesterol (-10.51 ± 0.77 mg/dl), triglyceride (-16.02 ± 1.7 mg/dl), low-density lipoprotein cholesterol (-9.33 ± 6.66 mg/dl; all P < 0.001), fat free mass (- 0.92 ± 0.90 kg; P < 0.003), and fasting blood sugar (-5.28 ± 1.36 mg/dl; P = 0.02) decreased significantly in PP in contrast to the placebo group in the raw model and when adjusted for confounders. Also, high-density lipoprotein cholesterol (5.10 ± 0.36 mg/dl), liver steatosis and stiffness (- 0.30 ± 0.17 and - 0.72 ± 0.35 kPa, respectively, all P < 0.001) improved in the PP group. However, fasting insulin (P = 0.81) and homeostatic model assessment for insulin resistance (HOMA-IR) (P = 0.93) were not significantly different when comparing two groups during the study in the raw and even adjusted models. CONCLUSION: In conclusion, 1500 mg pomegranate peel extract along with a weight-loss diet improved metabolic syndrome risk factors and reduced hepatic steatosis in patients with NAFLD after 8 weeks.

Animal and plant-based proteins have different postprandial effects on energy expenditure, glycemia, insulinemia, and lipemia: A review of controlled clinical trials.

Dietary proteins have been shown to stimulate thermogenesis, increase satiety, and improve insulin sensitivity in the short and long term. Animal-based proteins (AP) and plant-based proteins (PP) have different amino acid profiles, bioavailability, and digestibility, so it seems to have various short- and long-term effects on metabolic responses. This review aimed to compare the findings of controlled clinical trials on postprandial effects of dietary Aps versus PPs on energy expenditure (EE), lipemia, glycemia, and insulinemia. Data are inconclusive regarding the postprandial effects of APs and PPs. However, there is some evidence indicating that APs increase postprandial EE, DIT, and SO more than PPs. With lipemia and glycemia, most studies showed that APs reduce or delay postprandial glycemia and lipemia and increase insulinemia more than PPs. The difference in amino acid composition, digestion and absorption rate, and gastric emptying rate between APs and PPs explains this difference.

Adjunctive nano-curcumin therapy improves inflammatory and clinical indices in children with cystic fibrosis: A randomized clinical trial.

Inflammation may develop due to internal dysfunction of the cystic fibrosis transmembrane conductance regulator (CFTR) protein or external factors in patients with cystic fibrosis (CF). This prospective randomized clinical trial aimed to ascertain the effects of nano-curcumin as an anti-inflammatory agent and a CFTR modulator on clinical and inflammatory markers in children with CF. Children with CF were randomly assigned to receive daily curcumin or a placebo for 3 months. The primary outcome measure was to evaluate inflammatory indices, nasopharyngeal swab analysis, and clinical assessments via spirometry, anthropometric measurements, and quality of life (QOL) analysis. Sixty children were included. Intra-group changes comparison showed that curcumin decreased the level of high-sensitivity C-reactive protein (hs-CRP) (median: -0.31 mg/L, IQR: -1.53 to 0.81; p = .01) and fecal calprotectin level (-29 µg/g, -57.5 to 11.5; p = .03), also increased the level of interleukin (IL)-10 (6.1 pg/mL, 4.5-9; p = .01). Moreover, curcumin improved the overall QOL and the subscales of the questionnaire. Inter-group changes comparison depicted the number of Pseudomonas colonies reduced by about 52% in the curcumin group and gained weight by about 16% (p > .05). Nano-curcumin seems to be considered as an effective nutritional supplement on hs-CRP, IL-10, fecal calprotectin levels, and improving QOL in patients with CF.

Postprandial effects of dietary protein source on metabolic responses, appetite, and arterial stiffness indices in overweight and obese men: the study protocol for a randomized crossover clinical trial.

BACKGROUND: Different dietary protein sources are supposed to have various effects on metabolic responses and arterial stiffness in the postprandial period. This study aims to assess the postprandial effects of dietary protein sources, including animal-based protein (AP) and plant-based protein (PP), as part of a high-protein breakfast on appetite response, energy metabolism, and arterial stiffness in overweight and obese men. METHODS: This acute randomized crossover clinical trial will be conducted at the Persian study research center at Imam Reza Hospital, affiliated with the Mashhad University of Medical Sciences, located in the northeast of Iran. Forty-six healthy overweight, and obese men aged 18-60 years will be enrolled based on the eligibility criteria. The subjects will complete two interventions (high-protein AP and PP meals) with 1 week washout period. The primary outcome will be the acute effect of the two test meals on appetite response, energy metabolism parameters, including resting metabolism rate (RMR), diet-induced thermogenesis (DIT), and substrate oxidation (SO), and arterial stiffness indices, including pulse wave velocity (PWV) and pulse wave analysis (PWA). The secondary outcomes include changes in lipemia, glycemia, and insulinemia. DISCUSSION: The findings of this study will provide novel insight regarding the acute effects of different protein sources on energy metabolism, appetite, and arterial stiffness as a significant cardiovascular disease (CVD) risk factor. It will help dieticians develop effective and efficient meal plans to improve weight reduction and maintenance in overweight/obese individuals. TRIAL REGISTRATION: Iranian Registry of Clinical Trials; code: IRCT20211230053570N1; registered on February 10, 2022.

The effects of Chlorella vulgaris on cardiovascular risk factors: A comprehensive review on putative molecular mechanisms.

High incidence rate of cardiovascular disease (CVD) make this condition as an important public health concern. The use of natural products in treating this chronic condition has increased in recent years one of which is the single-celled green alga Chlorella. Chlorella vulgaris (CV) has been studied for its potential benefits to human health due to its biological and pharmacological features. CV contains a variety of macro and micronutrients, including proteins, omega-3, polysaccharides, vitamins, and minerals. Some studies have indicated that taking CV as a dietary supplement can help reduce inflammation and oxidative stress. In some studies, cardiovascular risk factors that are based on hematological indices did not show these benefits, and no molecular mechanisms have been identified. This comprehensive review summarized the research on the cardio-protective benefits of chlorella supplementation and the underlying molecular processes.

Soluble Fiber Supplementation and Serum Lipid Profile: A Systematic Review and Dose-Response Meta-Analysis of Randomized Controlled Trials.

To present a comprehensive synthesis of the effect of soluble fiber supplementation on blood lipid parameters in adults, a systematic search was undertaken in PubMed, Scopus, and ISI Web of Science of relevant articles published before November 2021. Randomized controlled trials (RCTs) evaluating the effects of soluble fibers on blood lipids in adults were included. We estimated the change in blood lipids for each 5 g/d increment in soluble fiber supplementation in each trial and then calculated the mean difference (MD) 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 and certainty of the evidence was evaluated using the Cochrane risk of bias tool and the Grading Recommendations Assessment, Development, and Evaluation methodology, respectively. A total of 181 RCTs with 220 treatment arms (14,505 participants: 7348 cases and 7157 controls) were included. There was a significant reduction in LDL cholesterol (MD: -8.28 mg/dL, 95% CI: -11.38, -5.18), total cholesterol (TC) (MD: -10.82 mg/dL, 95% CI: -12.98, -8.67), TGs (MD: -5.55 mg/dL, 95% CI: -10.31, -0.79), and apolipoprotein B (Apo-B) (MD: -44.99 mg/L, 95% CI: -62.87, -27.12) after soluble fiber supplementation in the overall analysis. Each 5 g/d increase in soluble fiber supplementation had a significant reduction in TC (MD: -6.11 mg/dL, 95% CI: -7.61, -4.61) and LDL cholesterol (MD: -5.57 mg/dl, 95% CI: -7.44, -3.69). In a large meta-analysis of RCTs, results suggest that soluble fiber supplementation could contribute to the management of dyslipidemia and the reduction of cardiovascular disease risk.

The role of Pycnogenol in the control of inflammation and oxidative stress in chronic diseases: Molecular aspects.

The prevalence of chronic diseases has increased significantly with the rising trend of sedentary lifestyles, reduced physical activity, and dietary modifications in recent decades. Inflammation and oxidative stress play a key role in the pathophysiology of several chronic diseases, such as type II diabetes, cardiovascular diseases, and hepatic conditions. Therefore, reducing inflammation and oxidative stress may be beneficial in the prevention and treatment of various chronic disorders. Since chronic diseases are not completely curable, various methods have been proposed for their control. Complementary therapies and the use of natural antioxidant and antiinflammatory compounds are among these novel approaches. Pycnogenol (PYC) is a natural compound that could control inflammation and oxidative stress. Furthermore, some previous studies have shown that PYC could effectively reduce inflammation through signaling the downstream of insulin receptors, inhibiting the phosphorylation of the serine residues of insulin receptor substrate-1, reducing pro-inflammatory cytokines and oxidative stress indices through the stimulation of antioxidant pathways, increasing free radical scavenging activities, preventing lipid peroxidation, and protecting the erythrocytes in glucose-6-phosphate dehydrogenase-deficient individuals, although these effects have not been fully proved. The present study aimed to comprehensively review the evidence concerning the positive physiological and pharmacological properties of PYC, with an emphasis on the therapeutic potential of this natural component for enhancing human health.

Does propolis have any effect on rheumatoid arthritis? A review study.

Rheumatoid arthritis (RA) is a chronic autoimmune disease in which inflammation and oxidative stress play a key role in its pathophysiology. Complementary therapies along with medications may be effective in the control of RA. Propolis is a natural substance extracted from beehives, which have confirmed anti-inflammatory and antioxidant effects. The present study aimed to review the possible effects of propolis on inflammation, oxidative stress, and lipid profile in patients with RA. English articles in online databases such as PubMed­Medline, AMED, Google Scholar, EMBASE, Scopus, and Web of Science databases were searched. Pieces of evidence show that supplementation with propolis may have therapeutic effects on RA patients. Due to increased inflammation and oxidative stress in the affected joints of RA patients, propolis could inhibit the inflammatory cascades by inhibiting the nuclear factor kappa B pathway and reducing reactive oxygen species, malondialdehyde, and interleukin-17 by increasing some antioxidants. Therefore, inflammation and pain reduce, helping improve and control RA in patients. Further investigations are required with larger sample sizes and different doses of propolis to demonstrate the definite effects of propolis on various aspects of RA.

Biological and pharmacological effects and nutritional impact of phytosterols: A comprehensive review.

Phytosterols (PSs), classified into plant sterols and stanols, are bioactive compounds found in foods of plant origin. PSs have been proposed to exert a wide number of pharmacological properties, including the potential to reduce total and low-density lipoprotein (LDL) cholesterol levels and thereby decreasing the risk of cardiovascular diseases. Other health-promoting effects of PSs include anti-obesity, anti-diabetic, anti-microbial, anti-inflammatory, and immunomodulatory effects. Also, anticancer effects have been strongly suggested, as phytosterol-rich diets may reduce the risk of cancer by 20%. The aim of this review is to provide a general overview of the available evidence regarding the beneficial physiological and pharmacological activities of PSs, with special emphasis on their therapeutic potential for human health and safety. Also, we will explore the factors that influence the physiologic response to PSs.

Macro- and Micro-nutrient Intake Adequacy in Gastric Bypass Patients after 24 Months: a Cross-sectional Study.

Decreased food intake is an effective mechanism for gastric bypass surgery (GBS) for successful weight loss. This cross-sectional study aimed to assess dietary intake, micro-and macro-nutrients in the patients undergoing GBS and determine the possible associations with weight changes. We assessed anthropometric indices and food intake at 24 month-post gastric bypass surgery. Dietary data was evaluated using three-day food records. After the 24 months of surgery, among 35 patients (mean age: 43.5 ± 11.2 years; 82.85% females), with the mean body mass index (BMI) of 30.5 ± 4.5 kg/m2, 17 cases were < 50% of their excess weight. The average daily calorie intake was 1,733 ± 630 kcal, with 14.88% of calories from protein. Consumption amounts of protein (0.82 ± 0.27 g/kg of the current weight), as well as fiber, and some micro-nutrients (vitamin B9, E, K, B5, and D3) were lower than recommended amounts. Patients were classified into three groups based on their success in weight loss after surgery. Calorie intake was not significantly different between groups, but successful groups consumed considerably more protein and less carbohydrate than the unsuccessful group (p < 0.05). Based on our findings, the patients undergoing GBS had inadequate macro- and micro-nutrient intake after 24 months. However, protein intake can affect patients' success in achieving better weight loss. Long-term cohort and clinical studies need to be conducted to comprehend this process further.