OPTIFIT-Optimal Fiber Trial for Diabetes Prevention
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Nutrition Disorders Obesity Overweight Metabolic Syndrome x Body Weight Glucose Metabolism Disorders Metabolic Diseases |
Dietary Supplement: Fiber Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | 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 |
- 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)
- Change of insulin sensitivity [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: No ]Measurement by HOMA and OGIS from the OGTT
- Change of insulin secretion [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: No ]Measurement by the OGTT
- Expression of inflammatory markers in blood [ Time Frame: 0, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]CRP, leukocytes, adipocytokines
- Biometric data [ Time Frame: 0, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]Nutritional impact of blood pressure, anthropometry (body weight and body composition)
- Assessment of cognitive performance [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: No ]
- Development of indices for the prediction of fat mass [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: No ]Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy
- Determination of gene expression in adipose tissue [ Time Frame: 0, 12, 24 month ] [ Designated as safety issue: No ]Determination of inflammatory and other transcripts in sc adipose tissue in a fat biopsy.
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2014 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Drink enriched in fibers
7,5g enriched fiber drinks, BID
|
Dietary Supplement: Fiber
200ml drinks enriched with 7,5g of fiber (90% insoluble fiber, 10% soluble fiber), BID, over 24 months
|
|
Experimental: Placebo drink
Placebo drink, BID
|
Dietary Supplement: Placebo
200ml Placebo, BID, over 24 months
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Impaired glucose tolerance
- Age>18years old
- both gender
Exclusion Criteria:
- Diabetes type 1 and type 2
- chronic or malignant disease
- Intake of metabolic influence drugs
- Food allergies, fiber intolerance
Contacts and Locations| Contact: Caroline Honig | +493084453362 | caroline.honig@charite.de |
| Contact: Hornemann Silke, MD | +4933200882791 | silke.hornemann@dife.de |
| Germany | |
| German Instiute of Human Nutrition | Recruiting |
| Potsdam-Rehbruecke, Nuthetal, Germany, 14558 | |
| Contact: Andreas FH Pfeiffer, Prof. +4933200882771 afhp@dife.de | |
| Contact: Silke Hornemann, MD +4933200882791 silke.hornemann@dife.de | |
| Principal Investigator: Andreas FH Pfeiffer, Prof. | |
| Sub-Investigator: Margrit Kemper, MD | |
| Sub-Investigator: Silke Hornemann, MD | |
| Charite University | Recruiting |
| Berlin, Germany, 12200 | |
| Contact: Andreas FH Pfeiffer, Prof. +493084452114 afhp@charite.de | |
| Contact: Honig Caroline +493084453362 caroline.honig@charite.de | |
| Principal Investigator: Andreas FH Pfeiffer, Prof. | |
| Sub-Investigator: Caroline Honig | |
| Principal Investigator: | Andreas FH Pfeiffer, Prof. | German Institute of Human Nutrition Potsdam-Rehbruecke |
More Information
No publications provided
| Responsible Party: | Prof. Dr. med. Andreas F. H. Pfeiffer, Chief, Department of Clinical Nutrition, German Institute of Human Nutrition |
| ClinicalTrials.gov Identifier: | NCT01681173 History of Changes |
| Other Study ID Numbers: | DDS-FKZ 232/11/08 |
| Study First Received: | September 5, 2012 |
| Last Updated: | September 5, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by German Institute of Human Nutrition:
|
Nutritional support Diet therapy Diabetes prevention |
Insoluble fiber Healthy life style Weight loss |
Additional relevant MeSH terms:
|
Body Weight Diabetes Mellitus Metabolic Diseases Nutrition Disorders Obesity Glucose Intolerance Overweight Metabolic Syndrome X |
Glucose Metabolism Disorders Signs and Symptoms Endocrine System Diseases Overnutrition Hyperglycemia Insulin Resistance Hyperinsulinism |
ClinicalTrials.gov processed this record on May 16, 2013