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| Name | Class |
|---|---|
| Wilhelm-Doerenkamp-Foundation (Funding) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drinking powder supplement | Dietary Supplement | Drinking powder supplement, to be taken twice daily over 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in fasting glucose | change in fasting glucose | 12 weeks |
| change in HbA1c | change in HbA1c | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in secondary GI peptide hormons (GLP-2, PP, ghrelin, CCK) | change in secondary GI peptide hormons (GLP-2, PP, ghrelin, CCK) | 12 weeks |
| change in fasting serum amino acid pattern | change in fasting serum amino acid pattern |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Kabisch, Dr. med. | Contact | 0049-30-450514429 | stefan.kabisch@charite.de | |
| Jasmin Hajir, cand.med. | Contact | 0049-30-450514428 | jasmin.hajir@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Kabisch, Dr. med. | Study physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite University Hospital Berlin | Recruiting | Berlin | 12203 | Germany |
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parallel-designed triple-blinded randomised placebo-controlled intervention study
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blinding applies to participants, study personnel and statistician
| 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 |
| change in incretins (GLP-1, GIP, PYY) | change in incretins (GLP-1, GIP, PYY) | 12 weeks |
| change in FGF21 | change in FGF21 | 12 weeks |
| change in IGF-1 and its binding proteins | change in IGF-1 and its binding proteins | 12 weeks |
| 12 weeks |
| change in faecal excretion of BCAA metabolites | change in faecal excretion of BCAA metabolites | 12 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006946 | Hyperinsulinism |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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