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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of One Single Dose of Different Bran-based Dietary Platforms on the Colon Metabolism - A Study With (Stable) Isotopes in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Unmodified wheat bran
* Dietary Supplement: Wheat bran with reduced particle size
* Dietary Supplement: Destarched pericarp-enriched wheat bran
* Dietary Supplement: No wheat bran fraction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unmodified wheat bran<br>One single dose om 20 g | Dietary Supplement: Unmodified wheat bran<br> <br> |
| Active Comparator: Wheat bran with reduced particle size<br>One single dose of 20 g | Dietary Supplement: Wheat bran with reduced particle size<br> <br> |
| Active Comparator: Destarched pericarp-enriched wheat bran<br>One single dose of 20 g | Dietary Supplement: Destarched pericarp-enriched wheat bran<br> <br> |
| Other: No bran-based dietary platform<br>No wheat bran fractions is administered | Dietary Supplement: No wheat bran fraction<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of acetate, propionate and butyrate production in the colon after consumption of each bran-based dietary platform |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of the site of fermentation of a readily fermentable carbohydrate in the presence of different bran-based dietary platforms |  | 2 years |