Biological Availability Clinical Trial
Official title:
Determination of Protein Digestibility of Whey and Zein in Ileostomates
The evaluation of protein quality has top priority according to Food and Agricultural Organization of the United Nations. However, one aspect of protein quality, namely the digestibility of protein is largely unknown. A database on this matter is lacking as it is difficult to measure ileal digestibility in humans.
Objective: This study aims to determine the digestibility of amino acids in two protein
sources in men and women with normally functioning ileostomies.
Study design: Intervention study with 6 test days, testing 3 meals each twice. Study
population: Eight men and women with normally functioning ileostomies will be recruited for
the study.
Intervention: On six separate test days, subjects will receive a meal, consisting of a drink
and biscuit. With this, two different protein containing meals, i.e. zein and whey, and a
protein-free meal is tested; these three treatments are given at two occasions, thus in total
6 meals are tested. After consumption of the meal, subjects collect their digesta for nine
hours.
Main study parameters/endpoints: Ileal amino acid digestibility of zein and whey protein
isolate.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: The subject will not benefit from the study except for the contribution to
scientific research. The risk of participating to this study is low, some gastrointestinal
discomfort could occur. Subjects have to come to the research facility seven times, a
screening visit of 1 hour, and 6 experimental days of 10 hours. Subjects will be financially
compensated for participation.
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