CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 target
Drug / intervention
Fiber +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01681173
NCT01681173N/ACompleted

Investigation of the Effect of Insoluble Dietary Fiber on Carbohydrate and Lipid Metabolism and the Prevention of Diabetes Mellitus Type 2 in Subjects With Impaired Glucose Tolerance

German Institute of Human Nutrition·interventional·Posted Sep 7, 2012·Updated Feb 5, 2015

In Brief

A clinical study evaluating Fiber and Placebo for Diabetes and 7 related conditions. Completed, enrolled 200 participants across 2 sites.

Detailed Summary

High intake of insoluble fiber is strongly associated with a reduced incidence of diabetes and cardiovascular events in prospective observation studies. Our primary objective is to compare a life style diabetes prevention program(PRAEDIAS) with and without added insoluble fibers in its effectiveness to prevent incident diabetes type 2 in high risk individuals with impaired glucose tolerance. Subjects with IGT not willing to participate in the intervention will be used as independent controls. Secondary aims are to identify mechanisms of action with regard to body composition, anti-inflammatory and metabolic effects of fibers. We propose a randomized, prospective intervention study. The results will be of general relevance for guidance of fiber intake in the population and will help the food industry to design healthy high fiber foods. Fiber can be added at low cost to numerous foods. Increased fiber intake may therefore provide a simple non-cognitive prevention strategy effective at the population level.

Study Details

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2012
Enrollment StartMay 1, 2010
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 13.8 years ago

Interventions

Fiberdietary

200ml drinks enriched with 7,5g of fiber (90% insoluble fiber, 10% soluble fiber), BID, over 24 months

Placebodietary

200ml Placebo, BID, over 24 months