Effect of Different Bran-based Dietary Platforms on the Colon Metabolism in Healthy Volunteers
This trial is active, not recruiting.
|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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||single blind (subject)|
|Primary purpose||basic science|
Quantification of acetate, propionate and butyrate production in the colon after consumption of each bran-based dietary platform
time frame: 2 years
Estimation of the site of fermentation of a readily fermentable carbohydrate in the presence of different bran-based dietary platforms
time frame: 2 years
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
|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|
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