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OPTIFIT-Optimal Fiber Trial for Diabetes Prevention

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ClinicalTrials.gov Identifier: NCT01681173
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : February 5, 2015
Sponsor:
Collaborators:
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

Tracking Information
First Submitted Date  ICMJE September 5, 2012
First Posted Date  ICMJE September 7, 2012
Last Update Posted Date February 5, 2015
Study Start Date  ICMJE May 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01681173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • Change of insulin sensitivity [ Time Frame: 0, 12, 24 months ]
    Measurement by HOMA and OGIS from the OGTT
  • Change of insulin secretion [ Time Frame: 0, 12, 24 months ]
    Measurement by the OGTT
  • Expression of inflammatory markers in blood [ Time Frame: 0, 6, 12, 18, 24 months ]
    CRP, leukocytes, adipocytokines
  • Biometric data [ Time Frame: 0, 6, 12, 18, 24 months ]
    Nutritional impact of blood pressure, anthropometry (body weight and body composition)
  • Assessment of cognitive performance [ Time Frame: 0, 12, 24 months ]
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes
  • Nutrition Disorders
  • Obesity
  • Overweight
  • Metabolic Syndrome x
  • Body Weight
  • Glucose Metabolism Disorders
  • Metabolic Diseases
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Honsek C, Kabisch S, Kemper M, Gerbracht C, Arafat AM, Birkenfeld AL, Dambeck U, Osterhoff MA, Weickert MO, Pfeiffer AFH. Fibre supplementation for the prevention of type 2 diabetes and improvement of glucose metabolism: the randomised controlled Optimal Fibre Trial (OptiFiT). Diabetologia. 2018 Jun;61(6):1295-1305. doi: 10.1007/s00125-018-4582-6. Epub 2018 Feb 28.

*   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 Completed
Estimated Enrollment  ICMJE
 (submitted: September 5, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01681173
Other Study ID Numbers  ICMJE DDS-FKZ 232/11/08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
Study Sponsor  ICMJE German Institute of Human Nutrition
Collaborators  ICMJE
  • Charite University, Berlin, Germany
  • German Diabetes Foundation, Munich, Germany
  • Klinikum Ernst von Bergmann Augenklinik Laserzentrum
  • University Hospital Tuebingen
Investigators  ICMJE
Principal Investigator: Andreas FH Pfeiffer, Prof. German Institute of Human Nutrition Potsdam-Rehbruecke
PRS Account German Institute of Human Nutrition
Verification Date February 2015

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