NCT07049224

Brief Summary

Muscles are composed out of proteins. These proteins in turn are composed out of smaller building blocks, called amino acids. By consuming a sufficient amount of dietary protein, a sufficient amount of amino acids become available to build new muscle proteins. The body's ability to build these new muscle proteins is of great importance to maintain muscle strength and function. Previous research suggests that a meal containing proteins from meat results in a better stimulation of the body's ability to build muscle proteins, when compared to a meal containing only plant-based proteins. However, these previous studies have only been performed following the ingestion of a single meal. As a result it is currently unknown how the muscles respond to a more prolonged ingestion of a diet containing animal/meat products, in comparison to a plant-based diet. Therefore, this study aims to investigate how fast new muscle proteins are being build when consuming a diet containing animal/meat products, in comparison to a plant-based (vegan) diet.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

July 3, 2025

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

December 19, 2024

Last Update Submit

June 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Integrated muscle protein synthesis rate in rested leg

    The main study endpoint will be the difference in muscle protein synthesis rates in the non-exercised leg, between the plant-based diet and the meat diet, expressed as FSR (%/day).

    The 2 intervention periods over which FSR is determined will each last 10 days

Secondary Outcomes (7)

  • Integrated muscle protein synthesis rate in exercised leg

    The 2 intervention periods over which FSR is determined will each last 10 days

  • Blood glucose

    The 2 intervention periods after which the outcomes are determined will each last 10 days

  • Blood insulin

    The 2 intervention periods after which the outcomes are determined will each last 10 days

  • Blood lipid profile

    The 2 intervention periods after which the outcomes are determined will each last 10 days

  • Blood inflammatory markers

    The 2 intervention periods after which the outcomes are determined will each last 10 days

  • +2 more secondary outcomes

Other Outcomes (7)

  • Participant characteristics

    At baseline, before start interventional period

  • Muscle histology characteristics

    At baseline, before start interventional period

  • Muscle signaling proteins

    The 2 intervention periods over which muscle signaling proteins are determined will each last 10 days

  • +4 more other outcomes

Study Arms (2)

MEAT-PLANT

EXPERIMENTAL

Participants will be subjected to a 10-day diet containing meat and animal products, followed by a 10-day diet containing plant products. During the interventional period participants will perform unilateral lower limb resistance exercise.

Other: Meat dietOther: Plant diet

PLANT-MEAT

EXPERIMENTAL

Participants will be subjected to a 10-day diet containing plant products, followed by a 10-day diet containing meat and animal products. During the interventional period participants will perform unilateral lower limb resistance exercise.

Other: Meat dietOther: Plant diet

Interventions

Participants will be subjected to a 10-day diet containing meat and animal products. During the interventional period participants will perform unilateral lower limb resistance exercise.

Also known as: Omnivorous diet
MEAT-PLANTPLANT-MEAT

Participants will be subjected to a 10-day diet containing plant products. During the interventional period participants will perform unilateral lower limb resistance exercise.

Also known as: Vegan diet
MEAT-PLANTPLANT-MEAT

Eligibility Criteria

Age65 Years - 85 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsHealthy older males and females are eligible to participate
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male or female sex
  • Aged between 65 and 85 y inclusive
  • BMI between 18.5 and 30 kg/m2 inclusive

You may not qualify if:

  • Not willing to consume meat/animal-based products during the study period
  • Any food allergies (e.g. milk, gluten, etc.)
  • Participating currently or in the 3 months prior to the study in a structured progressive exercise program.
  • Smoking
  • History of cardiovascular, respiratory, gastrointestinal, urogenital, neurological, psychiatric, dermatologic, musculoskeletal, metabolic, endocrine, haematological, immunologic disorders, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol, interfere with the execution of the experiment, or potential influence the study outcomes (to be decided by the study team and responsible physician)
  • Diagnosed with phenylketonuria (PKU)
  • Donated full blood 3 months prior to test day
  • Use of any medications that interferes with study participation and/or outcomes (i.e. corticosteroids, non-steroidal anti-inflammatories, gastric acid suppressing medication) as assessed by the study team and responsible medical doctor.
  • Use of DOAC, vitamin-K-antagonist, or multiple anticoagulants
  • Fasting blood glucose \>7 mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre+

Maastricht, Limburg, 6229ER, Netherlands

RECRUITING

MeSH Terms

Interventions

Diet, WesternDiet, Plant-BasedDiet, Vegan

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet TherapyNutrition TherapyTherapeuticsDiet, Vegetarian

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, counter-balanced, cross-over design, researchers and participants are not blinded, analysts are blinded.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2024

First Posted

July 3, 2025

Study Start

December 9, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

July 3, 2025

Record last verified: 2024-12

Locations