Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2018-05-04
2019-01-17
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Whey protein isolate
whey protein isolate
whey protein isolate
Zein
Zein
zein protein
Protein-free
protein-free
protein free
Interventions
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whey protein isolate
whey protein isolate
Zein
zein protein
protein-free
protein free
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 60
* Willing to eat animal protein
* Have a well-established and normally functioning terminal ileostomy, with stomal faeces of normal physiological consistency
* Good general health, meaning subjects should be well-recovered from the ileostomy operation, their underlying disease should be cured or in remission and they should not have any other major health problems
Exclusion Criteria
* Have been pregnant or breastfeeding in the last 12 months, or plan to become pregnant during the study
* Having renal impairment, coeliac disease or diabetes
* Drug abuse
* Alcohol consumption of \>14 units per week.
* Having an allergy or intolerance to dairy, corn products or fructose
* Currently taking protein supplements and would not be willing to stop using these during the study
* Being on a controlled diet or dietary weight loss regimen during the two weeks prior to the start of this study and/or during the study
* Personnel of division of Human Nutrition, Wageningen University..
* Current participation in other research from the Division of Human Nutrition
* Not having a general practitioner
18 Years
60 Years
ALL
Yes
Sponsors
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Massey University
OTHER
Global Dairy Platform Incorporated
UNKNOWN
Wageningen University
OTHER
Responsible Party
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Geleijnse
Prof. Dr.
Locations
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Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, Netherlands
Countries
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References
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van der Wielen N, de Vries S, Gerrits WJ, Lammers-Jannink K, Moughan PJ, Mensink M, Hendriks W. Presence of Unabsorbed Free Amino Acids at the End of the Small Intestine Indicates the Potential for an Increase in Amino Acid Uptake in Humans and Pigs. J Nutr. 2023 Mar;153(3):673-682. doi: 10.1016/j.tjnut.2023.01.038. Epub 2023 Feb 9.
Other Identifiers
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NL63446.081.17
Identifier Type: -
Identifier Source: org_study_id