OPTIFIT-Optimal Fiber Trial for Diabetes Prevention
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 5, 2012 | ||||||||
| Last Updated Date | September 5, 2012 | ||||||||
| Start Date ICMJE | May 2010 | ||||||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change of 2h-postprandial blood glucose from IGT to diabetes mellitus type 2 or normal glucose tolerance (NGT) [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: No ] Change of the glucose metabolism (OGTT) |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | OPTIFIT-Optimal Fiber Trial for Diabetes Prevention | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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. |
||||||||
| Detailed Description | The overall objective is to investigate whether insoluble fibers added to standard nutrition can reduce the progression of impairment of glucose metabolism in a high risk population with impaired glucose metabolism. Large prospective cohort studies clearly show that mainly insoluble cereal fiber from whole grains is associated with reduced risk of type 2 diabetes and cardiovascular disease. However, there is a lack of evidence from prospective intervention studies targeted to evaluate the potential of dietary fibers to reduce diabetes and cardiovascular disease as recently stated by the Cochrane Foundation. Dietary fiber intake is generally much lower than currently recommended, which may in part be related to side effects of whole grain nutrients and their gustatory properties. Intestinally uncomfortable effects are at least partly related to fermentation which is much less induced by insoluble non-fermentable fibers than by soluble fermentable fibers. The prospective demonstration of beneficial effects of insoluble fibers in preventing diabetes type 2 will allow detailed nutritional recommendations. This may serve to support the consumption of metabolically beneficial constituents of fiber-rich diets and help to increase fiber intake by high fiber natural nutrients or everyday nutrients enriched in insoluble natural fibers. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01681173 | ||||||||
| Other Study ID Numbers ICMJE | DDS-FKZ 232/11/08 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition | ||||||||
| Study Sponsor ICMJE | German Institute of Human Nutrition | ||||||||
| Collaborators ICMJE |
|
||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | German Institute of Human Nutrition | ||||||||
| Verification Date | September 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||