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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05654805

Collaborator

Wilhelm-Doerenkamp-Foundation (Funding) (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes NAFLD	Dietary Supplement: Drinking powder supplement	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parallel-designed triple-blinded randomised placebo-controlled intervention studyparallel-designed triple-blinded randomised placebo-controlled intervention study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

blinding applies to participants, study personnel and statistician

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Dietary Supplement: Drinking powder supplement Drinking powder supplement, to be taken twice daily over 12 weeks
Placebo Comparator: 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	Dietary Supplement: Drinking powder supplement Drinking powder supplement, to be taken twice daily over 12 weeks

Arm

Intervention/Treatment

Active Comparator: 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

Dietary Supplement: Drinking powder supplement

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

Placebo Comparator: 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

Dietary Supplement: Drinking powder supplement

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

Outcome Measures

Primary Outcome Measures

change in liver fat content (MRS) [12 weeks]
change in liver fat content (MRS)
change in glucose tolerance (mixed-meal test) [12 weeks]
change in glucose tolerance (mixed-meal test)
change in insulin resistance (Matsuda) [12 weeks]
change in insulin resistance (Matsuda)

Secondary Outcome Measures

change in fasting glucose [12 weeks]
change in fasting glucose
change in HbA1c [12 weeks]
change in HbA1c
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 incretins (GLP-1, GIP, PYY) [12 weeks]
change in incretins (GLP-1, GIP, PYY)
change in FGF21 [12 weeks]
change in FGF21
change in IGF-1 and its binding proteins [12 weeks]
change in IGF-1 and its binding proteins

Other Outcome Measures

change in secondary GI peptide hormons (GLP-2, PP, ghrelin, CCK) [12 weeks]
change in secondary GI peptide hormons (GLP-2, PP, ghrelin, CCK)
change in fasting serum amino acid pattern [12 weeks]
change in fasting serum amino acid pattern
change in faecal excretion of BCAA metabolites [12 weeks]
change in faecal excretion of BCAA metabolites

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

type 2 diabetes mellitus
HOMA-IR > 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