Eldery PeopleAPPETITENCT07155824
Impact of Plant Proteins and Exercise on Protein Metabolism in Older Adults
A study testing Whey and plant protein blend in people with Eldery People and Sedentarity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Eldery People, Sedentarity
- What is being tested?
- Whey and plant protein blend
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2025to 13 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Plant Proteins Fibre and Physical Activity Solutions to Modulate Whole Body and Skeletal Muscle 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
Read the detailed description
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
- Conditions
- Eldery People, Sedentarity
- Being tested
- Whey and plant protein blend
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey and plant protein blendDietary supplement
Also called Physical activity
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary proteins and physical activity | Experimental | Effect of physical activity program on protein metabolism following ingestion of whey or plant protein blend Receives: Dietary Supplement: Whey and plant protein blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Splanchnic extraction of amino acids
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.
Measured: At baseline (Week 0) and at follow-up (Weeks 12-13).
Secondary outcomes (2)
Whole body protein metabolism
Evaluation of protein turnover and amino acid oxidation using peripheral blood samples and breath tests before and after a 12-week physical activity program.
Measured: At baseline (Week 0) and at follow-up (Weeks 12-13).
Skeletal muscle signaling markers
Markers of plasticity, metabolism and denervation in skeletal muscle biopsy
Measured: At baseline (Week 0) and at follow-up (Weeks 12-13) following only the plant protein standardized meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start26 Aug 2025
- Primary completion13 May 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eldery PeopleStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Controled, monocentric, open label study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Université d'Auvergne, Friedrich-Alexander-Universität Erlangen-Nürnberg, University College Dublin, University of Padova
- Responsible party
- Sponsor
- Investigators
- Yves Boirie, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155824
- Sponsor's protocol ID
- RBHP 2023 RICHARD 2
- Other IDs
- ANSM
- Acronym
- APPETITE
- Status last verified
- May 2026
- First submitted
- 22 Jul 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Plant Proteins Fibre and Physical Activity Solutions to Modulate Whole Body and Skeletal Muscle Protein Metabolism in Older Adults
- ClinicalTrials.gov ID
- NCT07155824
- Acronym / sponsor ID
- APPETITE / RBHP 2023 RICHARD 2
- Conditions
- Eldery People, Sedentarity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Université d'Auvergne, Friedrich-Alexander-Universität Erlangen-Nürnberg, University College Dublin, University of Padova
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Controled, monocentric, open label study
| Arm | Type | Receives |
|---|---|---|
| Dietary proteins and physical activity | Experimental | Dietary Supplement: Whey and plant protein blendEffect of physical activity program on protein metabolism following ingestion of whey or plant protein blend |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey and plant protein blendAlso: Physical activityThe 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. | Dietary supplement | Dietary proteins and physical activity |
Primary outcome
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.
2 secondary outcomes
Whole body protein metabolism
Time frame: At baseline (Week 0) and at follow-up (Weeks 12-13).
Skeletal muscle signaling markers
Time frame: At baseline (Week 0) and at follow-up (Weeks 12-13) following only the plant protein standardized meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Eldery People
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
Eldery People, Cognitive Decline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Boirie principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey and plant protein blend in people with Eldery People and Sedentarity, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Splanchnic extraction of amino acids (time frame: At baseline (Week 0) and at follow-up (Weeks 12-13).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.