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

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how different types of protein in food can affect the way the body processes protein in older adults who are at risk of metabolic syndrome, a condition that can lead to heart disease and diabetes. The study will compare two types of protein sources: one from dairy and the other from a special blend of plant-based proteins. The goal is to see how these foods impact overall protein metabolism after eating.

To be eligible for the study, participants must be men aged 60 and older who have a larger waist circumference and specific levels of triglycerides and blood glucose that indicate a risk for metabolic syndrome. Participants will need to be able to provide consent and be in good health overall. Those who follow special diets, have significant recent weight loss, or take certain medications may not be able to participate. If you decide to join, you will consume one of the two protein products and take part in some assessments to help researchers understand how your body reacts. This is a great opportunity to contribute to important research that could benefit many older adults in the future!

Gender

MALE

Eligibility criteria

• 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 \> 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).