Effect of Different Bran-based Dietary Platforms on the Colon Metabolism in Healthy Volunteers

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: No wheat bran fraction; Dietary Supplement: Unmodified wheat bran; Dietary Supplement: Wheat bran with reduced particle size; Dietary Supplement: Destarched pericarp-enriched wheat bran

• Registration Number: NCT02422537
• Lead Sponsor: KU Leuven

Brief Summary

During this project the effect of 3 different bran-based dietary platforms on the fermentation on a readily fermentable substrate will be investigated using stable isotope techniques.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-21
• Primary Completion: 2015-07
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Healthy
• Aged between 18 and 65 years
• BMI between 18 and 27 kg/m²
• Stable eating pattern (3 meals/day on at least 5 days/week)

Exclusion Criteria

• Use of antibiotics in the month preceding the study
• Abdominal surgery (except from appendectomy)
• Use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication
• Use of pre- or probiotic supplements in the month preceding the study
• Chronic gastrointestinal diseases, such as inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease...
• Pregnancy or lactation
• Blood donation in the last 3 months
• Abnormal Hb-level (Standard range between 14 and 18 g/dL for men and between 12 and 16 g/dL for women)
• Participation in clinical studies involving radiation exposure in the past year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No bran-based dietary platform	No wheat bran fraction	No wheat bran fractions is administered
Unmodified wheat bran	Unmodified wheat bran	One single dose om 20 g
Wheat bran with reduced particle size	Wheat bran with reduced particle size	One single dose of 20 g
Destarched pericarp-enriched wheat bran	Destarched pericarp-enriched wheat bran	One single dose of 20 g

Primary Outcome Measures

Name	Time	Method
Quantification of acetate, propionate and butyrate production in the colon after consumption of each bran-based dietary platform	2 years

Secondary Outcome Measures

Name	Time	Method
Estimation of the site of fermentation of a readily fermentable carbohydrate in the presence of different bran-based dietary platforms	2 years

Trial Locations

Locations (1)

KU Leuven/ UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium