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OPTIFIT-Optimal Fiber Trial for Diabetes Prevention

NCT01681173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-02-05

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • German Diabetes Foundation, Munich, Germany

    collaborator UNKNOWN

  • Ernst von Bergmann Hospital

    collaborator OTHER

  • University Hospital Tuebingen

    collaborator OTHER

  • German Institute of Human Nutrition

    lead OTHER

Principal Investigators

  • Andreas FH Pfeiffer, Prof. · German Institute of Human Nutrition Potsdam-Rehbruecke

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01681173 on ClinicalTrials.gov