Not Yet RecruitingNot Applicable

Effect of a New Optimized Plant Ingredient on the Plant Protein of Seniors at Cardio-metabolic Risk

France10 participantsStarted 2025-05-14

Plain-language summary

The aim of the study is to compare the use of amino acids in whole-body protein metabolism in elderly consumers at risk of metabolic syndrome, after ingestion of 2 foods differing only in the nature of their proteins (optimized blend of vegetable proteins versus milk proteins). The protocol consists in studying the postprandial evolution of protein metabolism. Two products will be tested: one based on dairy proteins, the other on an optimized blend of vegetable proteins).

Who can participate

Age range

65 Years

Sex

MALE

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: * Waist circumference \> 94cm * Triglycerides \> 1.5 g/L or HDL cholesterol \< 0.4 g/L * Fasting blood glucose \< 1.26g/L * Biological profile considered compatible with study participation, * Venous status judged satisfactory by the nurses, allowing catheter placement for the study, * Individuals able to sign the informed consent form, * Persons subject to a social security scheme. Exclusion Criteria: * Subjects on special diets (vegetarian, vegan, etc.), * Subject showing a weight loss ≥ 5% in 1 month or ≥ 10% in 6 months compared to usual weight. * Subject refusing to stop taking dietary supplements for the duration of the study, * Subject refusing to consume any of the proposed products, * Subject with food allergy(ies) to one or more components of the products under study, or with a contraindication to the consumption of these products, * Subjects with a pathology or treatment (antidiabetics, hypolipidemics, corticoids, neuroleptics) judged by the investigator to be incompatible with the study, * Subjects with dysthyroidism that has not been stabilized for at least 3 months, * Subject with unstabilized hypertension for at least 3 months, * Subject with a medical and/or surgical history deemed by the investigator to be incompatible with the trial, * Subject having undergone surgery that could interfere with the study objectives (as judged by the investigating physician) in the 3 months preceding the study, * Smoking \> 5 cigarettes/day, * Alcohol \>…

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

Whole body protein metabolism

Timeframe: 8 months (including mass spectrometry analysis and calculations)

Trial details

NCT IDNCT06933589

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-01

Contact for this trial

Lise LACLAUTRE

+33473754963 promo_interne_drci@chu-clermontferrand.fr

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