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OPTIFIT-Optimal Fiber Trial for Diabetes Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01681173
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : February 5, 2015
Charite University, Berlin, Germany
German Diabetes Foundation, Munich, Germany
Klinikum Ernst von Bergmann Augenklinik Laserzentrum
University Hospital Tuebingen
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

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.

Condition or disease Intervention/treatment Phase
Diabetes Nutrition Disorders Obesity Overweight Metabolic Syndrome x Body Weight Glucose Metabolism Disorders Metabolic Diseases Dietary Supplement: Fiber Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : May 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change of 2h-postprandial blood glucose from IGT to diabetes mellitus type 2 or normal glucose tolerance (NGT) [ Time Frame: 0, 12, 24 months ]
    Change of the glucose metabolism (OGTT)

Secondary Outcome Measures :
  1. Change of insulin sensitivity [ Time Frame: 0, 12, 24 months ]
    Measurement by HOMA and OGIS from the OGTT

  2. Change of insulin secretion [ Time Frame: 0, 12, 24 months ]
    Measurement by the OGTT

  3. Expression of inflammatory markers in blood [ Time Frame: 0, 6, 12, 18, 24 months ]
    CRP, leukocytes, adipocytokines

  4. Biometric data [ Time Frame: 0, 6, 12, 18, 24 months ]
    Nutritional impact of blood pressure, anthropometry (body weight and body composition)

  5. Assessment of cognitive performance [ Time Frame: 0, 12, 24 months ]
  6. Development of indices for the prediction of fat mass [ Time Frame: 0, 12, 24 months ]
    Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy

  7. Determination of gene expression in adipose tissue [ Time Frame: 0, 12, 24 month ]
    Determination of inflammatory and other transcripts in sc adipose tissue in a fat biopsy.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01681173

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German Instiute of Human Nutrition
Potsdam-Rehbruecke, Nuthetal, Germany, 14558
Charite University
Berlin, Germany, 12200
Sponsors and Collaborators
German Institute of Human Nutrition
Charite University, Berlin, Germany
German Diabetes Foundation, Munich, Germany
Klinikum Ernst von Bergmann Augenklinik Laserzentrum
University Hospital Tuebingen
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Principal Investigator: Andreas FH Pfeiffer, Prof. German Institute of Human Nutrition Potsdam-Rehbruecke

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. med. Andreas F. H. Pfeiffer, Chief, Department of Clinical Nutrition, German Institute of Human Nutrition Identifier: NCT01681173     History of Changes
Other Study ID Numbers: DDS-FKZ 232/11/08
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015
Keywords provided by Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition:
Nutritional support
Diet therapy
Diabetes prevention
Insoluble fiber
Healthy life style
Weight loss
Additional relevant MeSH terms:
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Diabetes Mellitus
Metabolic Syndrome
Metabolic Diseases
Glucose Metabolism Disorders
Nutrition Disorders
Body Weight
Pathologic Processes
Endocrine System Diseases
Signs and Symptoms
Insulin Resistance