Skip to main content
OpenTrials
Completed

NCT Number: NCT07155824

Impact of Plant Proteins and Exercise on Protein Metabolism in Older Adults

To gain mechanistic insights by examining the impact of innovative plant-protein fibre products, physical activity interventions on digestibility, amino acid bioavailability and whole-body protein metabolism in older persons

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

Objective : to examine splanchnic extraction (SE), peripheral amino acid (AA) bioavailability and utilization (protein retention) from innovative plant proteins products, and muscle signalling markers before and after a physical activity (PA) program in inactive older persons

A randomized, crossover study including 12 inactive older men (65+ yrs) will be performed in order to compare the selected plant protein product to whey protein when included into a complete meal. During a kinetic day, each participant will consume alternatively, on 2 separate occasions, a test meal containing a plant protein mixture or 30 g whey protein. The methodology of stable isotope tracers: [15N] Leucine added to test meal and [1-13C] leucine administered intravenously will be used throughout a kinetic day, to evaluate the splanchnic extraction, the dietary amino acid bioavailability, and the whole body protein metabolism (protein synthesis, protein breakdown, AA oxidation and net balance). Carbon dioxide production rates will be measured by open-circuit indirect calorimetry. All measurements will be performed before the meal and post-prandial in regular intervals for 420 min.

In addition, postprandial plasma insulin and glucose will be determined in all samples, and a muscle biopsy will be collected post-prandially following the plant protein meal for examination of signalling markers of muscle plasticity (atrogin1, MURF1, LC3, BNIP3, Akt-dependent mTOR and FxO), metabolic adaptations (AMPK and PGC1alpha) and denervation (AChR subunits expression, agrin/MuSK/Lrp4, NCAM, and Myog) by UNIPD

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 22-30 kg/m²
  • Inactive (<150 minutes of moderate to vigorous physical activity per week and no regular resistance training),
  • Covered by a social security system
  • Agrees to undergo the study interventions (undirect calorimetry, functional tests, physical activity program)

Exclusion criteria

  • Hamilton HAD scale with a score > 9
  • Subject with a pathology or treatment (diabetic on insulin, corticosteroids > 8 days, neuroleptics, anticoagulant, antiplatelet) judged by the investigator as incompatible with the study
  • Subject with unstabilized thyroid dysfunction for at least 3 months
  • Subject with unstabilized hypertension for at least 3 months
  • Subject with a medical and/or surgical history judged by the investigator as incompatible with the trial
  • More than 21 alcoholic drinks per week
  • Heavy smoker (>10 cigarettes/day)
  • Currently participating in another intervention study
  • Absence of informed consent
  • Inability to participate in physical activity
  • Allergy(ies) or refusal to consume one of the foods tested as part of the the study
  • Allergy to local anesthetics
  • Declared glaucoma
  • Prostate hypertrophy
  • Refusal to register in the national file of volunteers who participate in research involving human beings
  • Subject in a period of exclusion from a previous study or having received a total amount of compensation greater than 6,000 euros over the 12 months preceding the start of the trial (after verification in the File of Volunteers for Research involving Human Beings)
  • Patients under guardianship, curatorship, deprived of liberty or legal protection
  • Subject with claustrophobia

Treatment and study plan

Whey and plant protein blend

Dietary Supplement

The 12 week intervention will involve 2 weekly group exercise sessions incorporating strength and balance exercises, along with home-based exercise focused on increasing time spent walking.

Other names: Physical activity

Primary outcomes

  1. Splanchnic extraction of amino acids

    Time frame: At baseline (Week 0) and at follow-up (Weeks 12-13).

    Change in splanchnic extraction of amino acids in response to standardized test meals (vegetal & animal proteins), assessed before and after a 12-week physical activity program.

Secondary outcomes

  1. Whole body protein metabolism

    Time frame: At baseline (Week 0) and at follow-up (Weeks 12-13).

    Evaluation of protein turnover and amino acid oxidation using peripheral blood samples and breath tests before and after a 12-week physical activity program.

  2. Skeletal muscle signaling markers

    Time frame: At baseline (Week 0) and at follow-up (Weeks 12-13) following only the plant protein standardized meal

    Markers of plasticity, metabolism and denervation in skeletal muscle biopsy

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Friedrich-Alexander-Universität Erlangen-Nürnberg
  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
  • University College Dublin
  • University of Padova
  • Université d'Auvergne

Registry information

Official study title

Innovative Plant Proteins Fibre and Physical Activity Solutions to Modulate Whole Body and Skeletal Muscle Protein Metabolism in Older Adults

Acronym: APPETITE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.