The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects
1 other identifier
interventional
50
1 country
1
Brief Summary
During this project the effect of modified wheat bran on colon health and systemic health will be evaluated in a long-term intervention study in healthy and obese subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Mar 2016
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 26, 2021
February 1, 2021
1.8 years
May 27, 2016
February 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo
1 month
Secondary Outcomes (9)
Changes in glucose levels (mg/dL)
1 month
Changes in insulin levels (pmol/L)
1 month
Changes in cholesterol levels (mg/dL)
1 month
Changes in free fatty acids levels (mmol/L)
1 month
Changes in triglyceride levels (mg/dL)
1 month
- +4 more secondary outcomes
Study Arms (4)
Healthy - Wheat Bran
ACTIVE COMPARATORWheat bran 20 g each day
Healthy - Placebo
PLACEBO COMPARATORPlacebo 20 g each day
Obese - Wheat bran
ACTIVE COMPARATORWheat bran 20 g each day
Obese - Placebo
PLACEBO COMPARATORPlacebo 20 g each day
Interventions
Eligibility Criteria
You may qualify if:
- Aged between 18 and 65 years old
- BMI between 18 and 25 kg/m² OR higher than 30 kg/m²
- Regular diet
- Not dieting
You may not qualify if:
- Use of antibiotics in the month preceding the study
- Diabetes Type 1 or 2
- 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
Leuven, Vlaams-Brabant, 3000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Kristin Verbeke
Study Record Dates
First Submitted
May 27, 2016
First Posted
June 13, 2016
Study Start
March 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
February 26, 2021
Record last verified: 2021-02