AgingMYOVEGNCT07681986
Plant-based Diet in Older People: What Consequences for Muscle Health?
A study testing Plant-enriched dietary intervention in people with Aging, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This randomized, controlled, two-arm clinical study aims to determine how increasing the proportion of plant-based foods in the diet affects skeletal muscle strength, mass and function, protein metabolism, microbiota and key metabolic markers in healthy older men and women. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Plant-enriched dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2026to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women aged 65 years and older
- Body Mass Index (BMI) between 18.5 and 30 kg/m² (exclusive)
- Physical activity ≤ 3000 MET-min/week, assessed using the ONAPS-PAQ questionnaire
- Laboratory tests compatible with participation in the study
- Adequate venous status, as assessed by study nurses, allowing catheter placement
- Willingness to participate in study procedures, including indirect calorimetry, functional tests, and assigned dietary intervention (plant-enriched or standard diet)
- Affiliation with the French Social Security system
Who cannot join
- Men and women aged 65 years and older
- Body Mass Index (BMI) between 18.5 and 30 kg/m² (exclusive)
- Physical activity < 3000 MET-min/week, assessed using the ONAPS-PAQ questionnaire
- Laboratory tests compatible with participation in the study
- Adequate venous status, as assessed by study nurses, allowing catheter placement
- Willingness to participate in study procedures, including indirect calorimetry, functional tests, and assigned dietary intervention (plant-enriched or standard diet)
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- Affiliation with the French Social Security system
- Exclusion period from a previous study or total compensation exceeding €6,000 in the 12 months prior to study initiation (verified through the National Research Volunteer Database)
- Patients under legal guardianship, curatorship, deprived of liberty, or under judicial protection
- Claustrophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Yves Boirie
About this study
This randomized, controlled, two-arm clinical study aims to determine how increasing the proportion of plant-based foods in the diet affects skeletal muscle strength, mass and function, protein metabolism, microbiota and key metabolic markers in healthy older men and women. We hypothesize that diets enriched with animal-based foods will maintain maximal quadriceps strength-the primary outcome of the study-more effectively after the 3-month nutritional intervention than plant-based diets. Proteomic analyses will be performed to identify molecular mechanisms and potential muscle biomarkers reflecting metabolic adaptations of skeletal muscle to plant-enriched diets. In addition, metabolic health markers and micronutrient status will be evaluated to better understand the overall health effects of dietary plant-based transition in older adults.
Read the detailed description
This exploratory, open-label, randomized, controlled, two-arm clinical study aims to evaluate how increasing the proportion of plant-based foods in the diet affects skeletal muscle health in older adults. The primary objective is to assess the impact of a plant-enriched diet on physical performance, specifically maximal quadriceps strength after a 3-month nutritional intervention.
Secondary objectives are to determine the effects of a plant-enriched diet on: (1) whole-body and muscle protein metabolism, (2) modifications in the skeletal muscle proteome and metabolome, (3) functional capacities, (4) body composition, (5) gut microbiota composition, and (6) sex-related differences in metabolic adaptability. The study will compare diets containing different proportions of plant-based foods in healthy older men and women.
Participants will undergo medical evaluation, nutritional follow-up, body composition measurements, muscle function testing, indirect calorimetry, and biological sampling including blood tests, and microbiota profiling. BBlood samples will be collected for proteomic and metabolomic analyses to identify molecular pathways and potential muscle biomarkers associated with adaptations to plant-enriched diets. In parallel, circulating amino acid concentrations will be measured to assess protein bioavailability, and blood samples will be incubated with skeletal muscle cells to evaluate the anabolic potential of the ingested proteins. Digestive tolerance, micronutrient status, and metabolic health markers will also be monitored.
The procedures are associated with minimal anticipated risks. Blood sampling may cause bruising and indirect calorimetry may result in mild discomfort. Plant-enriched diets may induce transient digestive symptoms or weight loss, which will be closely monitored. Participants experiencing clinically significant weight loss will be withdrawn from the intervention and followed until stabilization.
The findings of this study may strengthen public health recommendations promoting sustainable dietary transitions in older adults and help develop nutritional strategies aimed at maintaining optimal muscle health and supporting healthy aging.
- Conditions
- Aging
- Being tested
- Plant-enriched dietary intervention, Control diet
- Keywords
- Aging, Older Adults, Plant-Based Diet, Muscle Strength, Skeletal Muscle, Protein Metabolism, Physical Performance, Proteomics, Body Composition, Gut Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-enriched dietary interventionOther
Participants follow a diet enriched in plant-based foods with approximately 70% of protein from plant sources and 30% from animal sources for 3 months, with tailored dietary guidance, meal planning support, and compliance monitored through food diaries and periodic follow-up.
Control dietOther
Participants follow a standard diet with approximately 70% of protein from animal sources and 30% from plant sources for 3 months, with general nutritional guidance and compliance monitored through food diaries and periodic consultations.
| Study group | Role | What they receive |
|---|---|---|
| Control diet group | Active comparator | Participants follow a standard diet for older adults with approximately 70% of protein from animal sources and 30% from plant sources. Nutritional guidance and follow-up are provided throughout the 3-month study period. Participants maintain their usual eating habits within these proportions, and dietary compliance is monitored through food diaries and regular consultations with the study team. Receives: Other: Control diet |
| Plant-enriched diet group | Experimental | Participants follow a diet enriched in plant-based foods, with approximately 70% of protein from plant sources and 30% from animal sources, while maintaining adequate total protein intake. Participants receive tailored dietary guidance and support from the study team over 3 months, including meal planning and regular follow-up. Dietary compliance is assessed using food diaries, recalls, and periodic monitoring by the study team. Receives: Other: Plant-enriched dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Quadriceps Strength
Maximal voluntary contraction of the quadriceps muscle will be measured using a standardized dynamometer. This outcome evaluates the primary effect of the dietary intervention on skeletal muscle strength in older adults.
Measured: Baseline and Month 3
Secondary outcomes (9)
Protein metabolism
Assessment of plasma amino acid concentrations, ex vivo anabolic response, proteomic and metabolic profiling, and related biomarkers (glucose, insulin, cytokines).
Measured: Baseline and Month 3
Short Physical Performance Battery (SPPB) total score
Physical performance will be assessed using the Short Physical Performance Battery (SPPB), which combines balance, gait speed, and chair stand performance into a composite score ranging from 0 to 12 points. Higher scores indicate better physical function.
Measured: Baseline and Month 3
Handgrip strength
Handgrip strength will be measured using a calibrated hand dynamometer. The maximum grip strength will be recorded and reported in kilograms (kg). Higher values indicate greater muscle strength.
Measured: Baseline and Month 3
Distance covered during the 6-minute walk test
Functional exercise capacity will be assessed using the 6-minute walk test. The total distance walked during 6 minutes will be recorded and reported in meters (m). Higher values indicate better functional capacity.
Measured: Baseline and Month 3
Appendicular lean mass
Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry (DXA) and reported in kilograms (kg). Higher values indicate greater skeletal muscle mass.
Measured: Baseline and Month 3
Relative abundance of dominant gut bacterial taxa
Description: Stool samples will be analyzed using microbiome sequencing methods. Relative abundance of predefined dominant bacterial taxa will be quantified and reported as percentages of total bacterial abundance.
Measured: Baseline and Month 3
Sex-specific changes in maximal quadriceps strength
Quadriceps maximal voluntary contraction force will be measured using a standardized dynamometer and reported in Newtons (N). Changes from baseline will be compared between male and female participants to evaluate sex-specific responses to the dietary intervention.
Measured: Baseline and Month 3
Sex-specific changes in serum metabolomic and proteomic profiles
Serum metabolomic and proteomic profiles will be analyzed using validated metabolomics and proteomics platforms. Changes in predefined metabolites and proteins will be compared between male and female participants to evaluate sex-specific responses to the dietary intervention.
Measured: Baseline and Month 3
Sex-specific changes in appendicular lean mass
Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry (DXA) and reported in kilograms (kg). Changes from baseline will be compared between male and female participants to evaluate sex-specific responses to the dietary intervention.
Measured: Baseline and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start20 Jul 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary purpose of this study is to evaluate the effects of a dietary intervention-increasing the proportion of plant-based foods-on skeletal muscle strength and metabolism in older adults. Although no pharmaceutical treatment is used, the intervention aims to improve or maintain physical function and muscle health.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Université d'Auvergne, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
- Investigators
- Yves BOIRIE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681986
- Sponsor's protocol ID
- RBHP 2024 BOIRIE 2
- Other IDs
- 2024-A02027-40
- Acronym
- MYOVEG
- Status last verified
- Nov 2026
- First submitted
- 18 Jun 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plant-based Diet in Older People: What Consequences for Muscle Health?
- ClinicalTrials.gov ID
- NCT07681986
- Acronym / sponsor ID
- MYOVEG / RBHP 2024 BOIRIE 2
- Conditions
- Aging
- Keywords
- Aging, Older Adults, Plant-Based Diet, Muscle Strength, Skeletal Muscle, Protein Metabolism, Physical Performance, Proteomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Université d'Auvergne, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 2 Jul 2026 (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.
This randomized, controlled, two-arm clinical study aims to determine how increasing the proportion of plant-based foods in the diet affects skeletal muscle strength, mass and function, protein metabolism, microbiota and key metabolic markers in healthy older men and women. We hypothesize that diets enriched with animal-based foods will maintain maximal quadriceps strength-the primary outcome of the study-more effectively after the 3-month nutritional intervention than plant-based diets. Proteomic analyses will be performed to identify molecular mechanisms and potential muscle biomarkers reflecting metabolic adaptations of skeletal muscle to plant-enriched diets. In addition, metabolic health markers and micronutrient status will be evaluated to better understand the overall health effects of dietary plant-based transition in older adults.
Detailed description
This exploratory, open-label, randomized, controlled, two-arm clinical study aims to evaluate how increasing the proportion of plant-based foods in the diet affects skeletal muscle health in older adults. The primary objective is to assess the impact of a plant-enriched diet on physical performance, specifically maximal quadriceps strength after a 3-month nutritional intervention.
Secondary objectives are to determine the effects of a plant-enriched diet on: (1) whole-body and muscle protein metabolism, (2) modifications in the skeletal muscle proteome and metabolome, (3) functional capacities, (4) body composition, (5) gut microbiota composition, and (6) sex-related differences in metabolic adaptability. The study will compare diets containing different proportions of plant-based foods in healthy older men and women.
Participants will undergo medical evaluation, nutritional follow-up, body composition measurements, muscle function testing, indirect calorimetry, and biological sampling including blood tests, and microbiota profiling. BBlood samples will be collected for proteomic and metabolomic analyses to identify molecular pathways and potential muscle biomarkers associated with adaptations to plant-enriched diets. In parallel, circulating amino acid concentrations will be measured to assess protein bioavailability, and blood samples will be incubated with skeletal muscle cells to evaluate the anabolic potential of the ingested proteins. Digestive tolerance, micronutrient status, and metabolic health markers will also be monitored.
The procedures are associated with minimal anticipated risks. Blood sampling may cause bruising and indirect calorimetry may result in mild discomfort. Plant-enriched diets may induce transient digestive symptoms or weight loss, which will be closely monitored. Participants experiencing clinically significant weight loss will be withdrawn from the intervention and followed until stabilization.
The findings of this study may strengthen public health recommendations promoting sustainable dietary transitions in older adults and help develop nutritional strategies aimed at maintaining optimal muscle health and supporting healthy aging.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary purpose of this study is to evaluate the effects of a dietary intervention-increasing the proportion of plant-based foods-on skeletal muscle strength and metabolism in older adults. Although no pharmaceutical treatment is used, the intervention aims to improve or maintain physical function and muscle health.
| Arm | Type | Receives |
|---|---|---|
| Control diet group | Active comparator | Other: Control dietParticipants follow a standard diet for older adults with approximately 70% of protein from animal sources and 30% from plant sources. Nutritional guidance and follow-up are provided throughout the 3-month study period. Participants maintain their usual eating habits within these proportions, and dietary compliance is monitored through food diaries and regular consultations with the study team. |
| Plant-enriched diet group | Experimental | Other: Plant-enriched dietary interventionParticipants follow a diet enriched in plant-based foods, with approximately 70% of protein from plant sources and 30% from animal sources, while maintaining adequate total protein intake. Participants receive tailored dietary guidance and support from the study team over 3 months, including meal planning and regular follow-up. Dietary compliance is assessed using food diaries, recalls, and periodic monitoring by the study team. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Men and women aged 65 years and older
- Body Mass Index (BMI) between 18.5 and 30 kg/m² (exclusive)
- Physical activity ≤ 3000 MET-min/week, assessed using the ONAPS-PAQ questionnaire
- Laboratory tests compatible with participation in the study
- Adequate venous status, as assessed by study nurses, allowing catheter placement
Key exclusion criteria (10 listed)
- Men and women aged 65 years and older
- Body Mass Index (BMI) between 18.5 and 30 kg/m² (exclusive)
- Physical activity < 3000 MET-min/week, assessed using the ONAPS-PAQ questionnaire
- Laboratory tests compatible with participation in the study
- Adequate venous status, as assessed by study nurses, allowing catheter placement
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 |
|---|---|---|
| Plant-enriched dietary interventionParticipants follow a diet enriched in plant-based foods with approximately 70% of protein from plant sources and 30% from animal sources for 3 months, with tailored dietary guidance, meal planning support, and compliance monitored through food diaries and periodic follow-up. | Other | Plant-enriched diet group |
| Control dietParticipants follow a standard diet with approximately 70% of protein from animal sources and 30% from plant sources for 3 months, with general nutritional guidance and compliance monitored through food diaries and periodic consultations. | Other | Control diet group |
Primary outcome
Maximal Quadriceps Strength
Time frame: Baseline and Month 3
Maximal voluntary contraction of the quadriceps muscle will be measured using a standardized dynamometer. This outcome evaluates the primary effect of the dietary intervention on skeletal muscle strength in older adults.
9 secondary outcomes
Protein metabolism
Time frame: Baseline and Month 3
Short Physical Performance Battery (SPPB) total score
Time frame: Baseline and Month 3
Handgrip strength
Time frame: Baseline and Month 3
Distance covered during the 6-minute walk test
Time frame: Baseline and Month 3
Appendicular lean mass
Time frame: Baseline and Month 3
Relative abundance of dominant gut bacterial taxa
Time frame: Baseline and Month 3
Sex-specific changes in maximal quadriceps strength
Time frame: Baseline and Month 3
Sex-specific changes in serum metabolomic and proteomic profiles
Time frame: Baseline and Month 3
Sex-specific changes in appendicular lean mass
Time frame: Baseline and Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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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.
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 Plant-enriched dietary intervention in people with Aging, 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33475754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Quadriceps Strength (time frame: Baseline and Month 3). 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 4 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.