Dataset Information

A randomized Placebo-Controlled Clinical Trial to Evaluate the Medium-Term Effects of Oat Fibers on Human Health: The Beta-Glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT) Study.

ABSTRACT: The Beta-glucan Effects on Lipid profile, glycemia and inTestinal health (BELT) Study investigated the effect of 3 g/day oat beta-glucans on plasma lipids, fasting glucose and self-perceived intestinal well-being. The Study was an 8-week, double-blind, placebo-controlled, cross-over randomized clinical trial, enrolling a sample of 83 Italian free-living subjects, adherent to Mediterranean diet, with a moderate hypercholesterolemia and a low cardiovascular risk profile. Beta-glucans reduced mean LDL-Cholesterol (LDL-C) levels from baseline by 12.2% (95%CI: -15.4 to -3.8) after 4 weeks of supplementation and by 15.1% (95%CI: -17.8 to -5.9) after 8 weeks of supplementation (p < 0.01 for both comparison and versus placebo). Between baseline and 4 weeks Total Cholesterol (TC) levels showed an average reduction of 6.5% (95%CI: -10.9 to -1.9) in the beta-glucan sequence; while non-HDL-C plasma concentrations decreased by 11.8% (95%CI: -14.6 to -4.5). Moreover, after 8 weeks of beta-glucan supplementation TC was reduced by 8.9% (95%CI: -12.6 to -2.3) and non-HDL-C levels by 12.1% (95%CI: -15.6 to -5.3). Decreses in TC and non HDL-C were significant also versus placebo (respectively p < 0.05 and p < 0.01 to both follow-up visits). Fasting plasma glucose and self-perceived intestinal well-being were not affected by both beta-glucan and placebo supplementation.

SUBMITTER: Cicero AFG

PROVIDER: S-EPMC7146517 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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A randomized Placebo-Controlled Clinical Trial to Evaluate the Medium-Term Effects of Oat Fibers on Human Health: The Beta-Glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT) Study.

Cicero Arrigo F G AFG Fogacci Federica F Veronesi Maddalena M Strocchi Enrico E Grandi Elisa E Rizzoli Elisabetta E Poli Andrea A Marangoni Franca F Borghi Claudio C

Nutrients 20200303 3

The Beta-glucan Effects on Lipid profile, glycemia and inTestinal health (BELT) Study investigated the effect of 3 g/day oat beta-glucans on plasma lipids, fasting glucose and self-perceived intestinal well-being. The Study was an 8-week, double-blind, placebo-controlled, cross-over randomized clinical trial, enrolling a sample of 83 Italian free-living subjects, adherent to Mediterranean diet, with a moderate hypercholesterolemia and a low cardiovascular risk profile. Beta-glucans reduced mean ...[more]

PMID: 32138344

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Project description:BackgroundHealth claims regarding the cholesterol-lowering effect of soluble fiber from oat products, approved by food standards agencies worldwide, are based on a diet containing ≥3 g/d of oat β-glucan (OBG). Given the number of recently published randomized controlled trials (RCTs), it is important to update the findings of previous meta-analyses.ObjectiveThe objective was to quantify the effect of ≥3 g OBG/d on serum cholesterol concentrations in humans and investigate potential effect modifiers.DesignA meta-analysis was performed on 28 RCTs comparing ≥3 g OBG/d with an appropriate control. Systematic searches were undertaken in PubMed, AGRICOLA, and Scopus between 1 January 1966 and 6 June 2013, plus in-house study reports at CreaNutrition AG. Studies were assessed with regard to inclusion/exclusion criteria, and data were extracted from included studies by reviewers working independently in pairs, reconciling differences by consensus. Estimates of the mean reduction in serum cholesterol from baseline between the OBG and control diets were analyzed by using random-effects meta-analysis models and meta-regression.ResultsOBG in doses of ≥3 g/d reduced low-density lipoprotein (LDL) and total cholesterol relative to control by 0.25 mmol/L (95% CI: 0.20, 0.30; P < 0.0001) and 0.30 mmol/L (95% CI: 0.24, 0.35; P < 0.0001), respectively, with some indication of heterogeneity (P = 0.13 and P = 0.067). There was no significant effect of OBG on high-density lipoprotein (HDL) cholesterol or triglycerides and no evidence that dose (range across trials: 3.0-12.4 g/d) or duration of treatment (range: 2-12 wk) influenced the results. LDL cholesterol lowering was significantly greater with higher baseline LDL cholesterol. There was a significantly greater effect for both LDL and total cholesterol in subjects with diabetes compared with those without (although based on few studies).ConclusionsAdding ≥3 g OBG/d to the diet reduces LDL and total cholesterol by 0.25 mmol/L and 0.30 mmol/L, respectively, without changing HDL cholesterol or triglycerides.

Project description:Background & Aims: Non-alcoholic fatty liver disease (NALFLD)-associated changes in gut microbiota are important drivers of disease progression toward fibrosis. Therefore, reversing microbiota alterations could ameliorate NAFLD progression. Oat beta-glucan, a non-digestible polysaccharides, has shown promising therapeutic effects on hyperlipidemia associated with NAFLD, but its impact on gut microbiota and most importantly NAFLD fibrosis remains unknown. Methods: We performed detailed metabolic phenotyping including body composition, glucose tolerance, and lipid metabolism as well as comprehensive characterization of the gut-liver axis in a western-style diet (WSD)-induced model of NAFLD and assessed the effect of a beta-glucan intervention on early and advanced liver disease. Gut microbiota was modulated using broad-spectrum antibiotic (Abx) treatment. Results: Oat beta-glucan supplementation did not affect WSD-induced body weight gain, glucose intolerance, and the metabolic phenotype remained largely unaffected. Interestingly, oat beta-glucan dampened NAFLD inflammation, associated with significantly reduced monocyte-derived macrophages (MoMFs) infiltration, fibroinflammatory gene expression, and strongly reduced fibrosis development. Mechanistically, this protective effect was not mediated by changes in bile acid composition or signaling, but was dependent on gut microbiota and was lost upon Abx treatment. Specifically, oat beta-glucan partially reversed unfavorable changes in gut microbiota, resulting in an expansion of protective taxa, including Ruminococcus, and Lactobacillus followed by reduced translocation of TLR ligands. Conclusions: Our findings identify oat beta-glucan as a highly efficacious food supplement that dampens inflammation and fibrosis development in diet-induced NAFLD. These results, along with its favorable dietary profile, suggest that it may be a cost-effective and well-tolerated approach to preventing NAFLD progression and should be assessed in clinical studies.

Dataset Information

A randomized Placebo-Controlled Clinical Trial to Evaluate the Medium-Term Effects of Oat Fibers on Human Health: The Beta-Glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT) Study.

Publications

A randomized Placebo-Controlled Clinical Trial to Evaluate the Medium-Term Effects of Oat Fibers on Human Health: The Beta-Glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT) Study.

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