Plant-based Diet in Older People: What Consequences for Muscle Health?
ConditionAging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Plant-enriched dietary intervention
Other 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.
Control diet
Other interventionParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control diet groupActive comparator 1 intervention
Group B: Plant-enriched diet groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and Month 3Secondary outcomes
1
Protein metabolism
Assessment of plasma amino acid concentrations, ex vivo anabolic response, proteomic and metabolic profiling, and related biomarkers (glucose, insulin, cytokines).
Time frame
Baseline and Month 32
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.
Time frame
Baseline and Month 33
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.
Time frame
Baseline and Month 34
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.
Time frame
Baseline and Month 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Clermont-Ferrand
Lead sponsor
Centre de Recherche en Nutrition Humaine d'Auvergne
Collaborator
Université d'Auvergne
Collaborator
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborator
Source ClinicalTrials.gov
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