Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05654805
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2022-12-08
Brief Title:
Nutraceutical Improvement of Glucose Metabolism NAFLD and Insulin Resistance by Oat-fiber Supplementation in Type 2 Diabetes Mellitus Patients
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Nutraceutical Improvement of Glucose Metabolism NAFLD and Insulin Resistance by Oat-fiber Supplementation in Type 2 Diabetes Mellitus Patients
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIMROD
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None