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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01681173
Enrollment
200
Registered
2012-09-07
Start date
2010-05-31
Completion date
2014-12-31
Last updated
2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Nutrition Disorders, Obesity, Overweight, Metabolic Syndrome x, Body Weight, Glucose Metabolism Disorders, Metabolic Diseases

Keywords

Nutritional support, Diet therapy, Diabetes prevention, Insoluble fiber, Healthy life style, Weight loss

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.

Interventions

DIETARY_SUPPLEMENTFiber

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

DIETARY_SUPPLEMENTPlacebo

200ml Placebo, BID, over 24 months

Sponsors

Charite University, Berlin, Germany
CollaboratorOTHER
German Diabetes Foundation, Munich, Germany
CollaboratorUNKNOWN
Ernst von Bergmann Hospital
CollaboratorOTHER
University Hospital Tuebingen
CollaboratorOTHER
German Institute of Human Nutrition
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of 2h-postprandial blood glucose from IGT to diabetes mellitus type 2 or normal glucose tolerance (NGT)0, 12, 24 monthsChange of the glucose metabolism (OGTT)

Secondary

MeasureTime frameDescription
Change of insulin secretion0, 12, 24 monthsMeasurement by the OGTT
Expression of inflammatory markers in blood0, 6, 12, 18, 24 monthsCRP, leukocytes, adipocytokines
Biometric data0, 6, 12, 18, 24 monthsNutritional impact of blood pressure, anthropometry (body weight and body composition)
Change of insulin sensitivity0, 12, 24 monthsMeasurement by HOMA and OGIS from the OGTT
Development of indices for the prediction of fat mass0, 12, 24 monthsChange of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy
Determination of gene expression in adipose tissue0, 12, 24 monthDetermination of inflammatory and other transcripts in sc adipose tissue in a fat biopsy.
Assessment of cognitive performance0, 12, 24 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026