Nutraceutical Improvement of Glucose Metabolism, NAFLD and Insulin Resistance by Oat-fiber Supplementation in Type 2 Diabetes Mellitus Patients
- Conditions
- NAFLDType 2 Diabetes
- Interventions
- Dietary Supplement: Drinking powder supplement
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 92
- type 2 diabetes mellitus
- HOMA-IR > 2.5
- NAFLD (MR-S > 5,56 %)
- 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
- Arm && Interventions
Group Intervention Description Supplementation with insoluble cereal fiber Drinking powder supplement 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 Supplementation with placebo Drinking powder supplement 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
- 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 fasting glucose 12 weeks change in fasting glucose
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 HbA1c 12 weeks change in HbA1c
change in FGF21 12 weeks change in FGF21
Trial Locations
- Locations (1)
Charite University Hospital Berlin
🇩🇪Berlin, Germany