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
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Feb 2015
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 10, 2015
CompletedFirst Posted
Study publicly available on registry
April 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJanuary 31, 2017
January 1, 2017
5 months
April 10, 2015
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Quantification of acetate, propionate and butyrate production in the colon after consumption of each bran-based dietary platform
2 years
Secondary Outcomes (1)
Estimation of the site of fermentation of a readily fermentable carbohydrate in the presence of different bran-based dietary platforms
2 years
Study Arms (4)
Unmodified wheat bran
ACTIVE COMPARATOROne single dose om 20 g
Wheat bran with reduced particle size
ACTIVE COMPARATOROne single dose of 20 g
Destarched pericarp-enriched wheat bran
ACTIVE COMPARATOROne single dose of 20 g
No bran-based dietary platform
OTHERNo wheat bran fractions is administered
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
KU Leuven/ UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Kristin Verbeke
Study Record Dates
First Submitted
April 10, 2015
First Posted
April 21, 2015
Study Start
February 1, 2015
Primary Completion
July 1, 2015
Study Completion
January 1, 2017
Last Updated
January 31, 2017
Record last verified: 2017-01