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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422537
• Other study ID #: ML11202
• Status: Completed
• Phase: N/A
• First received: April 10, 2015
• Last updated: January 30, 2017
• Start date: February 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Unmodified wheat bran

• Wheat bran with reduced particle size

• Destarched pericarp-enriched wheat bran

• No wheat bran fraction

Locations

Country	Name	City	State
Belgium	KU Leuven/ UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of acetate, propionate and butyrate production in the colon after consumption of each bran-based dietary platform		2 years
Secondary	Estimation of the site of fermentation of a readily fermentable carbohydrate in the presence of different bran-based dietary platforms		2 years