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

NCT ID: NCT05654805

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2024-10-31

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.

Conditions

Type 2 Diabetes; NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Supplementation with insoluble cereal fiber

Drinking powder supplement providing 7,5 grams of insoluble fiber per sachet, taken twice daily over a period of 12 weeks without any changes in dietary behavior, caloric intake or physical activity

Group Type: ACTIVE_COMPARATOR

Drinking powder supplement

Intervention Type: DIETARY_SUPPLEMENT

Drinking powder supplement, to be taken twice daily over 12 weeks

Supplementation with placebo

Drinking powder supplement providing no insoluble fiber, but maltodextrin, taken twice daily over a period of 12 weeks without any changes in dietary behavior, caloric intake or physical activity

Group Type: PLACEBO_COMPARATOR

Drinking powder supplement

Intervention Type: DIETARY_SUPPLEMENT

Drinking powder supplement, to be taken twice daily over 12 weeks

Interventions

Drinking powder supplement

Drinking powder supplement, to be taken twice daily over 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wilhelm-Doerenkamp-Foundation (Funding)

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Stefan Kabisch

Study physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Kabisch, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Study physician

Locations

Charite University Hospital Berlin

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Stefan Kabisch, Dr. med.

Role: CONTACT

stefan.kabisch@charite.de

0049-30-450514429

Jasmin Hajir, cand.med.

Role: CONTACT

jasmin.hajir@charite.de

0049-30-450514428

Facility Contacts

Stefan Kabisch, Dr. med.

Role: primary

stefan.kabisch@charite.de

030 450 514 429

Other Identifiers

NIMROD

Identifier Type: -

Identifier Source: org_study_id