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NCT Number: NCT01681173

OPTIFIT-Optimal Fiber Trial for Diabetes Prevention

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.

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Key information

Conditions

Diabetes Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Instiute of Human Nutrition, Potsdam-Rehbruecke, Nuthetal, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fiber

Dietary Supplement

200ml drinks enriched with 7,5g of fiber (90% insoluble fiber, 10% soluble fiber), BID, over 24 months

Placebo

Dietary Supplement

200ml Placebo, BID, over 24 months

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Collaborators

  • Charite University, Berlin, Germany
  • Ernst von Bergmann Hospital
  • German Diabetes Foundation, Munich, Germany
  • University Hospital Tuebingen

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 7, 2012
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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