This trial is active, not recruiting.

Condition healthy
Treatments unmodified wheat bran, wheat bran with reduced particle size, destarched pericarp-enriched wheat bran
Phase phase 1/phase 2
Sponsor Katholieke Universiteit Leuven
Start date February 2015
End date July 2015
Trial size 10 participants
Trial identifier NCT02422537, ML11202


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose basic science
(Active Comparator)
One single dose om 20 g
unmodified wheat bran
(Active Comparator)
One single dose of 20 g
wheat bran with reduced particle size
(Active Comparator)
One single dose of 20 g
destarched pericarp-enriched wheat bran
(No Intervention)
No wheat bran fractions is administered

Primary Outcomes

Quantification of acetate, propionate and butyrate production in the colon after consumption of each bran-based dietary platform
time frame: 2 years

Secondary Outcomes

Estimation of the site of fermentation of a readily fermentable carbohydrate in the presence of different bran-based dietary platforms
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title The Effect of One Single Dose of Different Bran-based Dietary Platforms on the Colon Metabolism - A Study With (Stable) Isotopes in Healthy Volunteers
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Katholieke Universiteit Leuven.