- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07681986
Plant-based Diet in Older People: What Consequences for Muscle Health? (MYOVEG)
Study Overview
Status
Conditions
Intervention / Treatment
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 Participants experiencing clinically significant weight loss will be withdrawn from the intervention and followed until stabilization.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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lise LACLAUTRE
- Phone Number: +33475754963
- Email: promo_interne_drci@chu-clermontferrand.fr
Study Locations
-
-
-
Clermont-Ferrand, France
- CHU de Clermont-Ferrand
-
Contact:
- Lise Laclautre
- Phone Number: +33473754963
- Email: promo_interne_drci@chu-clermontferrand.fr
-
Principal Investigator:
- Yves Boirie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control diet group
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.
|
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.
|
|
Experimental: Plant-enriched diet group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Protein metabolism
Time Frame: Baseline and Month 3
|
Assessment of plasma amino acid concentrations, ex vivo anabolic response, proteomic and metabolic profiling, and related biomarkers (glucose, insulin, cytokines).
|
Baseline and Month 3
|
|
Short Physical Performance Battery (SPPB) total score
Time Frame: Baseline and Month 3
|
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.
|
Baseline and Month 3
|
|
Handgrip strength
Time Frame: Baseline and Month 3
|
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.
|
Baseline and Month 3
|
|
Distance covered during the 6-minute walk test
Time Frame: Baseline and Month 3
|
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.
|
Baseline and Month 3
|
|
Appendicular lean mass
Time Frame: Baseline and Month 3
|
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.
|
Baseline and Month 3
|
|
Relative abundance of dominant gut bacterial taxa
Time Frame: Baseline and Month 3
|
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.
|
Baseline and Month 3
|
|
Sex-specific changes in maximal quadriceps strength
Time Frame: Baseline and Month 3
|
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.
|
Baseline and Month 3
|
|
Sex-specific changes in serum metabolomic and proteomic profiles
Time Frame: Baseline and Month 3
|
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.
|
Baseline and Month 3
|
|
Sex-specific changes in appendicular lean mass
Time Frame: Baseline and Month 3
|
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.
|
Baseline and Month 3
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yves BOIRIE, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RBHP 2024 BOIRIE 2
- 2024-A02027-40 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aging
-
Florida Institute for Human and Machine CognitionNot yet recruitingAging | Healthy Aging | Aging WellUnited States
-
University of CopenhagenRecruitingAging | Healthy Aging | Aging FrailtyDenmark
-
Radboud University Medical CenterTerminated
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
Northwestern UniversityPotocsnak Human Longevity LabRecruitingAging | Aging Well | Aging, Biological | Aging, HealthyUnited States
-
Centre Hospitalier Universitaire de NiceNot yet recruitingAging | Aging Disorder | Aging, HealthyFrance
-
Centre Hospitalier Universitaire de NiceNot yet recruitingAging | Aging, HealthyFrance
-
University of Santiago de CompostelaEuropean Regional Development Fund; Center for Industrial Technological Development...Completed
-
University of West AtticaNot yet recruiting
-
University of Santiago de CompostelaState Research Agency, SpainCompleted
Clinical Trials on Control diet
-
Fazer GroupNokia Technologies Oy; Nightingale Health Oy; Tekes - the Finnish Funding Agency... and other collaboratorsCompletedCognitive Performance | Physiological Stress | LDL CholesterolFinland
-
Lund UniversityLund University HospitalCompletedObesity | Diet Modification | Cardiovascular Risk FactorSweden
-
Universidade Federal do Rio de JaneiroCompletedType 1 Diabetes MellitusBrazil
-
Isfahan University of Medical SciencesCompleted
-
Marjukka KolehmainenLund University; Uppsala University; Aarhus University Hospital; University of... and other collaboratorsCompletedCardiovascular Diseases | Insulin Resistance | Type 2 Diabetes | Impaired Glucose Tolerance | Abdominal ObesitySweden, Denmark, Finland, Iceland, Norway
-
Fundació Institut de Recerca de l'Hospital de la...University of BarcelonaCompleted
-
University of GeorgiaCompletedInflammation | ObesityUnited States
-
Azienda Ospedaliero, Universitaria PisanaCompletedObesity | Diabetes Mellitus, Type 2 | Weight Loss | Nutrition, HealthyItaly
-
Polish Academy of SciencesUniversity of Warmia and MazuryActive, not recruiting
-
Duke UniversityCompletedHypertension | Chronic Kidney DiseaseUnited States