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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
200
German Instiute of Human Nutrition
Potsdam-Rehbruecke, Nuthetal, Germany
Charite University
Berlin, State of Berlin, Germany
Change of 2h-postprandial blood glucose from IGT to diabetes mellitus type 2 or normal glucose tolerance (NGT)
Change of the glucose metabolism (OGTT)
Time frame: 0, 12, 24 months
Change of insulin sensitivity
Measurement by HOMA and OGIS from the OGTT
Time frame: 0, 12, 24 months
Change of insulin secretion
Measurement by the OGTT
Time frame: 0, 12, 24 months
Expression of inflammatory markers in blood
CRP, leukocytes, adipocytokines
Time frame: 0, 6, 12, 18, 24 months
Biometric data
Nutritional impact of blood pressure, anthropometry (body weight and body composition)
Time frame: 0, 6, 12, 18, 24 months
Assessment of cognitive performance
Time frame: 0, 12, 24 months
Development of indices for the prediction of fat mass
Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy
Time frame: 0, 12, 24 months
Determination of gene expression in adipose tissue
Determination of inflammatory and other transcripts in sc adipose tissue in a fat biopsy.
Time frame: 0, 12, 24 month
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