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

NCT05654805 | Unknown

• 1 other identifier: NIMROD
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; NAFLD

Keywords

insoluble cereal fiber; insulin resistance; glucose tolerance; inflammation; incretins

Outcome Measures

Primary Outcomes (3)

• change in liver fat content (MRS)

  change in liver fat content (MRS)

  12 weeks

• change in glucose tolerance (mixed-meal test)

  change in glucose tolerance (mixed-meal test)

  12 weeks

• change in insulin resistance (Matsuda)

  change in insulin resistance (Matsuda)

  12 weeks

Secondary Outcomes (6)

• change in fasting glucose

  12 weeks

• change in HbA1c

  12 weeks

• change in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-22

  12 weeks

• change in incretins (GLP-1, GIP, PYY)

  12 weeks

• change in FGF21

  12 weeks

Other Outcomes (3)

• change in secondary GI peptide hormons (GLP-2, PP, ghrelin, CCK)

  12 weeks

• change in fasting serum amino acid pattern

  12 weeks

• change in faecal excretion of BCAA metabolites

  12 weeks

Study Arms (2)

Supplementation with insoluble cereal fiber

ACTIVE COMPARATOR

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

Dietary Supplement: Drinking powder supplement

Supplementation with placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Drinking powder supplement

Interventions

Drinking powder supplement DIETARY_SUPPLEMENT

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

Supplementation with insoluble cereal fiber; Supplementation with placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Wilhelm-Doerenkamp-Foundation (Funding): collaborator

Study Sites (1)

Charite University Hospital Berlin

Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease; Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Hyperinsulinism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Kabisch, Dr. med.

  Study physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Kabisch, Dr. med.

CONTACT

0049-30-450514429; stefan.kabisch@charite.de

Jasmin Hajir, cand.med.

CONTACT

0049-30-450514428; jasmin.hajir@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: blinding applies to participants, study personnel and statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study physician

Model Details: parallel-designed triple-blinded randomised placebo-controlled intervention study

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: December 15, 2022
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)