Amino Acid Digestibility of Whey and Zein Proteins (NCT03279211) | Clinical Trial Compass
CompletedNot Applicable
Amino Acid Digestibility of Whey and Zein Proteins
France40 participantsStarted 2017-10-01
Plain-language summary
The main goal of the study is to determine true ileal amino acid digestibility of whey protein isolate (WPI) and zein proteins in healthy subjects equipped with naso-ileal tube. The endogenous losses of proteins and amino acids will be determined by collecting digesta samples after a protein-free diet in a third group of subjects.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Normal body weight (18 \< BMI \< 30 kg.m-2)
* Women or men
* 18 - 65 y
* Healthy
* Insured under the French social security system
* Signed informed consent
* For women: use of birth control
Exclusion Criteria:
* People under trusteeship
* Latex, cow milk or corn allergy A
* HIV, hepatite C virus antibodies, hepatite B virus surface antigen and core antibodies positive
* Pregnant women
* Excessive alcohol drinking or drugs intake
* Hypertension, diabetes, digestive tract, liver or renal diseases, severe heart disease
* High sport practicing (\> 7h/week)
* Blood donation in the 3 months prior to the study
* Participation in a clinical study in the 3 months prior to the study
* No signed informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determination of the concentration of amino acids from dietary sources (whey or zein) in the ileal digesta collected during 9 hours after meal intake to calculate the digestibility of amino acids from whey or zein protein sources.
Timeframe: Hour 0 to 9 after intake
Trial details
NCT IDNCT03279211
SponsorInstitut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement