Bioavailability of Protein and Amino Acids of Pea Protein Isolate in Healthy Volunteers (NCT04072770) | Clinical Trial Compass
CompletedNot Applicable
Bioavailability of Protein and Amino Acids of Pea Protein Isolate in Healthy Volunteers
France28 participantsStarted 2019-06-19
Plain-language summary
The study aims to determine in healthy subjects the bioavailability of protein and amino acids of pea protein isolate and casein isolate. For this purpose, the investigators will compare two methods:
1. the standard method consisting in measuring the ileal digestibility using ileal tubes,
2. an alternative method that has been proposed by an Food and Agriculture Organization (FAO) expert group: the dual isotope method.
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:
* 18\<BMI\<30
* Healthy
* Insured under the French social security system
* For women: use of birth control
* Signed informed consent
Exclusion Criteria:
* Any dietary allergy
* Latex allergy
* Positive serology to HIV, hepatite C virus antibody, hepatite B virus surface antigen and core antibodies
* Gluten intolerance
* Anemia
* Use of drugs
* High consumption of alcohol
* Hypertension, diabetes, digestive disease, hepatic or renal disease, severe cardiac disease
* Pregnancy
* High sport practicing (\>7h/wk)
* 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
Percentage of ileal digestibility of pea proteins and casein
Timeframe: -30 minute to 8 hours after the meal
2
Percentage of ileal digestibility of amino acids from pea proteins and casein
Timeframe: -30 minute to 8 hours after the meal
3
Percentage of net postprandial protein utilization of pea proteins and casein
Timeframe: -30 minute to 8 hours after the meal
4
Postprandial concentration of dietary amino acids in plasma
Timeframe: -30 minute to 8 hours after the meal
5
Postprandial concentration of glucose in plasma
Timeframe: -30 minute to 8 hours after the meal
6
Postprandial concentration of insulin in plasma
Timeframe: -30 minute to 8 hours after the meal
Trial details
NCT IDNCT04072770
SponsorInstitut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement