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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • KU Leuven/ UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 21, 2015

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ML11202