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Plant-based Diet in Older People: What Consequences for Muscle Health? (MYOVEG)

26 giugno 2026 aggiornato da: University Hospital, Clermont-Ferrand
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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: Control diet
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.
Sperimentale: 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.
Altro: Plant-enriched dietary intervention
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximal Quadriceps Strength
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Protein metabolism
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Clermont-Ferrand

Collaboratori

Université d'Auvergne
Centre de Recherche en Nutrition Humaine d'Auvergne
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Investigatori

  • Investigatore principale: Yves BOIRIE, University Hospital, Clermont-Ferrand

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 luglio 2026

Completamento primario (Stimato)

1 agosto 2029

Completamento dello studio (Stimato)

1 agosto 2030

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • RBHP 2024 BOIRIE 2
  • 2024-A02027-40 (Altro identificatore: ANSM)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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