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

26. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Sonstiges: 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.
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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Maximal Quadriceps Strength
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Protein metabolism
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Clermont-Ferrand

Mitarbeiter

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

Ermittler

  • Hauptermittler: Yves BOIRIE, University Hospital, Clermont-Ferrand

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. Juli 2026

Primärer Abschluss (Geschätzt)

1. August 2029

Studienabschluss (Geschätzt)

1. August 2030

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juni 2026

Zuerst gepostet (Tatsächlich)

2. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • RBHP 2024 BOIRIE 2
  • 2024-A02027-40 (Andere Kennung: ANSM)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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