OPTIFIT-Optimal Fiber Trial for Diabetes Prevention

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681173
• Other study ID #: DDS-FKZ 232/11/08
• Status: Completed
• Phase: N/A
• First received: September 5, 2012
• Last updated: February 4, 2015
• Start date: May 2010
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: German Institute of Human Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Weight
• Diabetes
• Disease
• Glucose Metabolism Disorders
• Metabolic Diseases
• Metabolic Syndrome X
• Nutrition Disorders
• Obesity
• Overweight

Intervention

Dietary Supplement:
• Fiber
200ml drinks enriched with 7,5g of fiber (90% insoluble fiber, 10% soluble fiber), BID, over 24 months
• Placebo
200ml Placebo, BID, over 24 months

Locations

Country	Name	City	State
Germany	Charite University	Berlin
Germany	German Instiute of Human Nutrition	Potsdam-Rehbruecke	Nuthetal

Sponsors (5)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	Charite University, Berlin, Germany, German Diabetes Foundation, Munich, Germany, Klinikum Ernst von Bergmann Augenklinik Laserzentrum, University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of 2h-postprandial blood glucose from IGT to diabetes mellitus type 2 or normal glucose tolerance (NGT)	Change of the glucose metabolism (OGTT)	0, 12, 24 months	No
Secondary	Change of insulin sensitivity	Measurement by HOMA and OGIS from the OGTT	0, 12, 24 months	No
Secondary	Change of insulin secretion	Measurement by the OGTT	0, 12, 24 months	No
Secondary	Expression of inflammatory markers in blood	CRP, leukocytes, adipocytokines	0, 6, 12, 18, 24 months	No
Secondary	Biometric data	Nutritional impact of blood pressure, anthropometry (body weight and body composition)	0, 6, 12, 18, 24 months	No
Secondary	Assessment of cognitive performance		0, 12, 24 months	No
Secondary	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	0, 12, 24 months	No
Secondary	Determination of gene expression in adipose tissue	Determination of inflammatory and other transcripts in sc adipose tissue in a fat biopsy.	0, 12, 24 month	No