Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALabsorption 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.