Trials / Completed
CompletedNCT00128804
The STOVITA Study - Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients
Bioefficacy and Bioavailability of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients Measuring Using Specifically 13C-Labelled Beta-Carotene and Retinol
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (planned)
- Sponsor
- Radboud University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
A controlled dietary intervention study will be carried out based on the stable isotope method the investigators have developed to quantify both the absorption of beta-carotene and its bioconversion to retinol in oil and in a mixed diet. For 4 weeks the participants will consume 2 capsules/day, 7 days/week with each capsule containing 100-mg \[13C10\] beta-carotene and 100-mg \[13C10\] retinyl palmitate. For two weeks they will consume a diet with high levels of beta-carotene in vegetables and fruits and for the other 2 weeks they will consume a diet with low levels of beta-carotene in vegetables and fruits supplemented with an extra amount of beta-carotene in oil. Samples of blood and faeces will be taken. The study hypothesis is that the absorption of beta-carotene in oil in comparison with the absorption of beta-carotene in a mixed diet differs by a factor of 3 to 6. The investigators want to measure the influence of the food matrix of vegetables and fruits on the absorption of beta-carotene in ileostomy patients on a western diet.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | absorption and conversion of beta-carotene in human gastrointestinal (GI) tract |
Timeline
- Start date
- 2004-07-01
- Completion
- 2004-10-01
- First posted
- 2005-08-10
- Last updated
- 2005-08-29
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT00128804. Inclusion in this directory is not an endorsement.