OPTIFIT-Optimal Fiber Trial for Diabetes Prevention

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by German Institute of Human Nutrition
Sponsor:
Collaborators:
Charite University, Berlin, Germany
German Diabetes Foundation, Munich, Germany
Clinical Ernst von Bergmann, Potsdam, Germany
University Hospital Tuebingen
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
ClinicalTrials.gov Identifier:
NCT01681173
First received: September 5, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted

September 5, 2012
September 5, 2012
May 2010
May 2012   (final data collection date for primary outcome measure)
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)
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
OPTIFIT-Optimal Fiber Trial for Diabetes Prevention
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Diabetes
  • Nutrition Disorders
  • Obesity
  • Overweight
  • Metabolic Syndrome x
  • Body Weight
  • Glucose Metabolism Disorders
  • Metabolic Diseases
  • Dietary Supplement: Fiber
    200ml drinks enriched with 7,5g of fiber (90% insoluble fiber, 10% soluble fiber), BID, over 24 months
  • Dietary Supplement: Placebo
    200ml Placebo, BID, over 24 months
  • Experimental: Drink enriched in fibers
    7,5g enriched fiber drinks, BID
    Intervention: Dietary Supplement: Fiber
  • Experimental: Placebo drink
    Placebo drink, BID
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2014
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Caroline Honig +493084453362 caroline.honig@charite.de
Contact: Hornemann Silke, MD +4933200882791 silke.hornemann@dife.de
Germany
 
NCT01681173
DDS-FKZ 232/11/08
No
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
German Institute of Human Nutrition
  • Charite University, Berlin, Germany
  • German Diabetes Foundation, Munich, Germany
  • Clinical Ernst von Bergmann, Potsdam, Germany
  • University Hospital Tuebingen
Principal Investigator: Andreas FH Pfeiffer, Prof. German Institute of Human Nutrition Potsdam-Rehbruecke
German Institute of Human Nutrition
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP