The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects | NCT02796989 | Trialant
CompletedInterventionalPhase 1Phase 2Updated Feb 26, 2021
The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects
ClinicalTrials.gov ID
NCT02796989
Lead Sponsor
KU LeuvenOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1Phase 2
Enrollment
50Actual
Last Update Posted
Feb 26, 2021Actual
Start Date
Mar 2016
Primary Completion Date
Dec 2017Actual
Completion Date
Dec 2017Actual
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.
Healthy
Obese
Wheat bran
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
Aged between 18 and 65 years old
BMI between 18 and 25 kg/m² OR higher than 30 kg/m²
Regular diet
Not dieting
Exclusion Criteria:
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