NCT04207372

Protein Digestibility of Whey and Zein.

Determination of Protein Digestibility of Whey and Zein in Ileostomates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Wageningen University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Biological Availability

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	whey protein isolate	whey protein isolate
DIETARY_SUPPLEMENT	Zein	zein protein
OTHER	protein-free	protein free

Timeline

• Start date: 2018-05-04
• Primary completion: 2019-01-17
• Completion: 2019-01-17
• First posted: 2019-12-20
• Last updated: 2019-12-20

Locations

1 site across 1 country: Netherlands