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

Type 2 Diabetes Clinical Trial

— NIMROD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654805
• Other study ID #: NIMROD
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Charite University, Berlin, Germany
• Contact: Stefan Kabisch, Dr. med.
• Phone: 0049-30-450514429
• Email: stefan.kabisch[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Drinking powder supplement
Drinking powder supplement, to be taken twice daily over 12 weeks

Locations

Country	Name	City	State
Germany	Charite University Hospital Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Wilhelm-Doerenkamp-Foundation (Funding)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in secondary GI peptide hormons (GLP-2, PP, ghrelin, CCK)	change in secondary GI peptide hormons (GLP-2, PP, ghrelin, CCK)	12 weeks
Other	change in fasting serum amino acid pattern	change in fasting serum amino acid pattern	12 weeks
Other	change in faecal excretion of BCAA metabolites	change in faecal excretion of BCAA metabolites	12 weeks
Primary	change in liver fat content (MRS)	change in liver fat content (MRS)	12 weeks
Primary	change in glucose tolerance (mixed-meal test)	change in glucose tolerance (mixed-meal test)	12 weeks
Primary	change in insulin resistance (Matsuda)	change in insulin resistance (Matsuda)	12 weeks
Secondary	change in fasting glucose	change in fasting glucose	12 weeks
Secondary	change in HbA1c	change in HbA1c	12 weeks
Secondary	change in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-22	change in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-22	12 weeks
Secondary	change in incretins (GLP-1, GIP, PYY)	change in incretins (GLP-1, GIP, PYY)	12 weeks
Secondary	change in FGF21	change in FGF21	12 weeks
Secondary	change in IGF-1 and its binding proteins	change in IGF-1 and its binding proteins	12 weeks