- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04207372
Protein Digestibility of Whey and Zein.
Determination of Protein Digestibility of Whey and Zein in Ileostomates
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
-
Wageningen, Gelderland, Netherlands, 6703 HA
- Division of Human Nutrition, Wageningen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female
- 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:
- Taken antibiotics or medication that majorly impair small intestinal digestion and absorption within eight weeks of participating in the study.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whey protein isolate
|
whey protein isolate
|
Experimental: Zein
|
zein protein
|
Placebo Comparator: Protein-free
|
protein free
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the ileal amino acid digestibility of Zein and Whey Protein Isolate
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.
|
9 hours per day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NL63446.081.17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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