NCT05985369

Brief Summary

Dietary protein intake and physical activity are key to minimise the age-related loss of skeletal muscle mass. While animal-derived protein sources are considered high-quality anabolic foods, it remains unclear whether non-animal-derived (vegan) protein sources support skeletal muscle maintenance and healthy ageing. The aim of the present study is to assess the effect of a vegan diet on daily muscle protein synthesis rates compared to a protein-matched omnivorous diet where the majority of protein is derived from high-quality animal-based protein sources.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

August 2, 2023

Last Update Submit

April 23, 2024

Conditions

Keywords

Muscle metabolismProtein metabolismSarcopeniaResistance exercise

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis (MPS) in resting and exercised tissue

    Daily MPS rates, expressed as fractional synthetic rate (%/h)

    7 days

Secondary Outcomes (1)

  • Muscle morphology

    7 days

Study Arms (2)

Vegan diet

EXPERIMENTAL

Participants will be allocated to a fully controlled 1-week vegan diet containing 0.8 g/kg BW/day of protein where all protein provided will be derived from non-animal-derived protein sources.

Other: Controlled diet and resistance exercise

Omnivorous diet

EXPERIMENTAL

Participants will be allocated to a fully controlled 1-week omnivorous diet containing 0.8 g/kg BW/day of protein where the majority of protein will be derived from animal-derived protein sources.

Other: Controlled diet and resistance exercise

Interventions

Participants will adopt a 1-week completely controlled diet and perform 3 sessions of unilateral leg resistance exercise.

Omnivorous dietVegan diet

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 18.5 - 30
  • Active (not very sedentary and not master athlete; assessed via IPAQ)
  • Women only: post menopause

You may not qualify if:

  • Hypertension (\>150/90 mmHg)
  • Any diagnosed metabolic impairment
  • Any diagnosed cardiovascular disease
  • Any diagnosed gastrointestinal disease
  • Diagnosed cancer
  • Any medication known to affect muscle metabolism (e.g. hormone replacement therapy)
  • Severe food allergies or intolerances (e.g. celiac, lactose intolerance, allergic to fungi or algae foods)
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devond, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start

November 9, 2022

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations