OPTIFIT-Optimal Fiber Trial for Diabetes Prevention

NCT01681173 | Completed

• 1 other identifier: DDS-FKZ 232/11/08
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change of insulin sensitivity

  0, 12, 24 months

• Change of insulin secretion

  0, 12, 24 months

• Expression of inflammatory markers in blood

  0, 6, 12, 18, 24 months

• Biometric data

  0, 6, 12, 18, 24 months

• Assessment of cognitive performance

  0, 12, 24 months

Study Arms (2)

Drink enriched in fibers

EXPERIMENTAL

7,5g enriched fiber drinks, BID

Dietary Supplement: Fiber

Placebo drink

EXPERIMENTAL

Placebo drink, BID

Dietary Supplement: Placebo

Interventions

Fiber DIETARY_SUPPLEMENT

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

Drink enriched in fibers

Placebo DIETARY_SUPPLEMENT

200ml Placebo, BID, over 24 months

Placebo drink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Impaired glucose tolerance
• Age\>18years old
• both gender

You may not qualify if:

• Diabetes type 1 and type 2
• chronic or malignant disease
• Intake of metabolic influence drugs
• Food allergies, fiber intolerance

Sponsors & Collaborators

• German Institute of Human Nutrition: lead
• Charite University, Berlin, Germany: collaborator
• German Diabetes Foundation, Munich, Germany: collaborator
• Ernst von Bergmann Hospital: collaborator
• University Hospital Tuebingen: collaborator

Study Sites (2)

German Instiute of Human Nutrition

Potsdam-Rehbruecke, Nuthetal, 14558, Germany

Location

Charite University

Berlin, State of Berlin, 12200, Germany

Location

Related Publications (2)

• Kabisch S, Montagna F, Honsek C, Kemper M, Gerbracht C, Arafat AM, Birkenfeld AL, Dambeck U, Osterhoff MA, Weickert MO, Floel A, Pfeiffer AFH. Effects of lifestyle intervention and supplementation with insoluble oat fiber on cognitive functions in patients with prediabetes: a secondary analysis of the Optimal Fiber Trial. Front Nutr. 2026 Jan 16;12:1699958. doi: 10.3389/fnut.2025.1699958. eCollection 2025.

  PMID: 41624204 DERIVED

• Honsek C, Kabisch S, Kemper M, Gerbracht C, Arafat AM, Birkenfeld AL, Dambeck U, Osterhoff MA, Weickert MO, Pfeiffer AFH. Fibre supplementation for the prevention of type 2 diabetes and improvement of glucose metabolism: the randomised controlled Optimal Fibre Trial (OptiFiT). Diabetologia. 2018 Jun;61(6):1295-1305. doi: 10.1007/s00125-018-4582-6. Epub 2018 Feb 28.

  PMID: 29492637 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Nutrition Disorders; Obesity; Overweight; Metabolic Syndrome; Body Weight; Glucose Metabolism Disorders; Metabolic Diseases; Weight Loss

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Body Weight Changes

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Andreas FH Pfeiffer, Prof.

  German Institute of Human Nutrition Potsdam-Rehbruecke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Clinical Nutrition

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 7, 2012
• Study Start: May 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 5, 2015

Record last verified: 2015-02

Locations

DE (2)