Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, 6703 HA, Netherlands
NCT Number: NCT04207372
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Wageningen, Gelderland, 6703 HA, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
whey protein isolate
zein protein
protein free
Time frame: 9 hours per day
ileal digesta samples are collected in the nine hours after consumption of these proteins and after consumption of a protein-free diet.
Wageningen University
Other
Determination of Protein Digestibility of Whey and Zein in Ileostomates
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06774911
Bioavailability and AUC, Biological Availability
Reus, Spain
View Trial DetailsNCT03886766
Amorphous Solid Dispersions, Biological Availability
Basel, Switzerland
View Trial DetailsNCT06137703
Biological Availability
Miami, Florida, United States
View Trial DetailsNCT05525910
Biological Availability, COVID-19
New Haven, Connecticut, United States
View Trial Details