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

NCT06933589 | Not Yet Recruiting

• 2 other identifiers: RBHP 2023 RICHARD2023-A00959-36
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Nutrition, Healthy; Metabolic Syndrome

Keywords

Protein

Outcome Measures

Primary Outcomes (1)

• Whole body protein metabolism

  Body leucine flux kinetics: oxidation, protein synthesis

  8 months (including mass spectrometry analysis and calculations)

Secondary Outcomes (3)

• Satiety effect

  12 months

• Evolution of blood parameters related to satiety

  12 months

• Product tolerance

  12 months

Study Arms (2)

Plant proteins

EXPERIMENTAL

Test meal incorporating an optimized plant protein ingredient

Other: Test meal with plant protein

Milk protein

ACTIVE COMPARATOR

Test meal incorporating milk proteins

Other: Test meal with milk protein

Interventions

Test meal with plant protein OTHER

The plant protein blend is made up of 5 protein ingredients for which the food grade is guaranteed: a rice protein isolate, a potato protein isolate, a lupin protein isolate, a corn protein isolate.

Plant proteins

Test meal with milk protein OTHER

The milk protein product is a food-grade protein isolate.

Milk protein

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Plant Proteins; Milk Proteins

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Animal Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Milk; Dairy Products; Food and Beverages

Study Officials

• Yves BOIRIE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

• Didier REMOND

  Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

  STUDY DIRECTOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Participants will not know which protein ingredient is included in the test-meal.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject is asked to test 2 different products during 2 kinetics of 9.5 hours each. Each kinetic is separated by a wash-out period of at least 2 weeks.

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: April 18, 2025
• Study Start: May 14, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 18, 2025

Record last verified: 2024-09

Locations

FR (1)