Short Chain Fatty Acids Bioavailability Clinical Trial
Official title:
Evaluation of the Bioavailability and Production of Short Chain Fatty Acids in the Colon. A Stable Isotope Study in Healthy Humans.
| NCT number | NCT01757379 |
| Other study ID # | ML5768 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | December 21, 2012 |
| Last updated | January 13, 2015 |
| Start date | April 2011 |
| Verified date | January 2015 |
| Source | Katholieke Universiteit Leuven |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Interventional |
The purpose of the study is to evaluate the bioavailability of acetate, propionate and
butyrate in healthy humans using a stable isotope technology.
In addition the level of acetate, propionate and butyrate production from inulin will be
determined using the principle of isotope dilution.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Healthy volunteers - Regular dietary pattern (3 meals/day) - Age: 18-65y - BMI: 18,5-27 kg/m2 Exclusion Criteria: - Intake of antibiotics 1 month prior to the study - Abdominal surgery in the past, with the exception of appendectomy - Intake of medication influencing the gastro-intestinal system 14 days prior to the study - In treatment at a dietician - Intake of pre- and/or probiotics - Exposure to radioactivity 1 year prior to the study - Serious chronic disease of the gastrointestinal tract - Use of medication that affects the gastro-intestinal tract during the last 2 weeks prior to the study - Pregnancy, pregnancy desire or lactation - Blood donation during the last 3 months prior to the study - Diabetes (type 1 or 2) - Aberrant hemoglobin level (Hb) in blood. Normal between 14.0 and 18.0 g/dL for men and between 12.0 and 16.0 g/dL for women |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Belgium | KU Leuven/ UZ Leuven | Leuven | Vlaams-Brabant |
| Lead Sponsor | Collaborator |
|---|---|
| Katholieke Universiteit Leuven |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Concentrations of the short chain fatty acids (acetate, propionate and butyrate) in plasma and urine samples | Participants performed each 4 test days and they were followed each test day for 12 hours, with sample collections at regular time points. Blood samples were collected every hour during the first 4 hours and afterwards every 20 minutes during 8 hours. Urine samples were collected during 24h in different fractions: 0-4h, 4-8h, 8-12h, 12-24h. | 12 hours each test day and 4 test days/volunteer | No |