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

Catholic University (KU) of Leuven

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Wheat bran with reduced particle size; Dietary Supplement: No wheat bran fraction; Dietary Supplement: Destarched pericarp-enriched wheat bran; Dietary Supplement: Unmodified wheat bran

Study type: Interventional

Funder types: Other

Identifiers

NCT02422537

ML11202

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 4 patient groups

Unmodified wheat bran

Active Comparator group

Description:

One single dose om 20 g

Treatment:

Dietary Supplement: Unmodified wheat bran

Wheat bran with reduced particle size

Active Comparator group

Description:

One single dose of 20 g

Treatment:

Dietary Supplement: Wheat bran with reduced particle size

Destarched pericarp-enriched wheat bran

Active Comparator group

Description:

One single dose of 20 g

Treatment:

Dietary Supplement: Destarched pericarp-enriched wheat bran

No bran-based dietary platform

Other group

Description:

No wheat bran fractions is administered

Treatment:

Dietary Supplement: No wheat bran fraction