Nutraceutical Improvement of Glucose Metabolism, NAFLD and Insulin Resistance by Oat-fiber Supplementation in Type 2 Diabetes Mellitus Patients

Not Applicable

Recruiting

• Conditions: NAFLD; Type 2 Diabetes

• Registration Number: NCT05654805
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Cohort studies show an association between increased intake of insoluble (cereal) fiber and decreased risk for cardiovascular disease, type 2 diabetes (T2DM), non-alcoholic fatty liver disease (NAFLD), cancer, infectious and inflammatory disorders. Intervention studies, specifically addressing non-fermentable carbohydrates instead of their food sources (whole grain, pulses, legumes) are still sparse. Whole grain trials reported beneficial effects, but cannot pinpoint these benefits on fiber, as minerals, vitamins, grain protein and food matrix contribute to the metabolic results.

The antidiabetic effectiveness of cereal fiber might be explained by a) an increased secretion of incretins and other glucose-induced gastrointestinal hormones, b) an alteration of the gut microbiome, or c) a fermentation to short-chain fatty acids. Fermentable fibers (most of which are soluble) show these mechanisms, but lack strong diabetes-protective associations in cohort studies. In recent supplementation trials, insoluble, mostly non-fermentable fibers improved insulin resistance, glycemia and inflammation in patients with metabolic syndrome or prediabetes.

Between 2022-2024, we want to assess the effectiveness of insoluble, poorly fermentable cereal fiber in a shorter Intervention period in patients with high responsiveness (insulin-naïve overt type 2 diabetes mellitus with insulin resistance and NAFLD), using a fiber drinking supplement. Our triple-blinded RCT compares the metabolic effects and mechanistic outcomes of isocaloric treatments with 15 grams of oat-fiber supplement per day (vs. placebo) in 92 patients, covering an intervention period of 12 weeks.

Detailed Description

Cohort studies show an association between increased intake of insoluble (cereal) fiber and decreased risk for cardiovascular disease, type 2 diabetes (T2DM), non-alcoholic fatty liver disease (NAFLD), cancer, infectious and inflammatory disorders. Intervention studies, specifically addressing non-fermentable carbohydrates instead of their food sources (whole grain, pulses, legumes) are still sparse. Whole grain trials reported beneficial effects, but cannot pinpoint these benefits on fiber, as minerals, vitamins, grain protein and food matrix contribute to the metabolic results.

The antidiabetic effectiveness of cereal fiber might be explained by a) an increased secretion of incretins and other glucose-induced gastrointestinal hormones, b) an alteration of the gut microbiome, or c) a fermentation to short-chain fatty acids. Fermentable fibers (most of which are soluble) show these mechanisms, but lack strong diabetes-protective associations in cohort studies. In recent supplementation trials, insoluble, mostly non-fermentable fibers improved insulin resistance, glycemia and inflammation in patients with metabolic syndrome or prediabetes.

Between 2022-2024, we want to assess the effectiveness of insoluble, poorly fermentable cereal fiber in a shorter Intervention period in patients with high responsiveness (insulin-naïve overt type 2 diabetes mellitus with insulin resistance and NAFLD), using an oat fiber drinking supplement. Our triple-blinded RCT compares the metabolic effects and mechanistic outcomes of isocaloric treatments with 15 grams of oat-fiber supplement per day (vs. placebo) in 92 patients, covering an intervention period of 12 weeks.

Study Timeline

• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-08
• Study Start: 2022-12-15
• Study First Posted: 2022-12-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-08
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• type 2 diabetes mellitus
• HOMA-IR > 2.5
• NAFLD (MR-S > 5,56 %)

Exclusion Criteria

• insulin treatment
• diabetes type 1, 3 or 4
• severe cardiopulmonary, renal, inflammatory, gastrointestinal, psychiatric or endocrine disorder
• alcohol abuse or excess alcohol intake
• recent CVD event (< 3months)
• relevant liver disease other than NAFLD
• current cancer diagnosis or treatment
• allergy or incompatibility to the supplement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in insulin resistance (Matsuda)	12 weeks	change in insulin resistance (Matsuda)
change in glucose tolerance (mixed-meal test)	12 weeks	change in glucose tolerance (mixed-meal test)
change in liver fat content (MRS)	12 weeks	change in liver fat content (MRS)

Secondary Outcome Measures

Name	Time	Method
change in incretins (GLP-1, GIP, PYY)	12 weeks	change in incretins (GLP-1, GIP, PYY)
change in FGF21	12 weeks	change in FGF21
change in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-22	12 weeks	change in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-22
change in IGF-1 and its binding proteins	12 weeks	change in IGF-1 and its binding proteins
change in fasting glucose	12 weeks	change in fasting glucose
change in HbA1c	12 weeks	change in HbA1c

Trial Locations

Locations (1)

Charite University Hospital Berlin; 🇩🇪 Berlin, Germany