Status:
NOT_YET_RECRUITING
Effect of a New Optimized Plant Ingredient on the Plant Protein of Seniors at Cardio-metabolic Risk
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conditions:
Nutrition, Healthy
Metabolic Syndrome
Eligibility:
MALE
65+ years
Phase:
NA
Brief 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 o...
Detailed Description
Written consent will be obtained from subjects after they have been informed of the aims, nature and possible risks of the study. Prior to inclusion, subjects will have a medical check-up carried out...
Eligibility Criteria
Inclusion
- 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
- 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 \> 3 glasses/day,
- Claustrophobic subject,
- Person refusing to be registered with the French Ministry of Health's Fichier National des Volontaires Sains,
- Major under guardianship or with limited rights,
- Subject not affiliated to social security,
- Subject in a period of exclusion from a previous study or having received a total amount of compensation exceeding 6000 euros over the 12 months preceding the start of the trial (after verification in the Fichier des Volontaires pour la Recherche Biomédicale).
Key Trial Info
Start Date :
May 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06933589
Start Date
May 14 2025
End Date
May 31 2026
Last Update
April 18 2025
Active Locations (1)
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1
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000