Vegan and Omnivorous Diets and Skeletal Muscle Turnover in Healthy Older Adults (MVP)

April 23, 2024 updated by: University of Exeter

The Effects of a High-quality Vegan Diet on Skeletal Muscle Maintenance and Adaptation in Comparison to a Protein-matched Omnivorous Diet in Healthy Older Adults.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: The age-related loss of muscle mass and strength is (partly) explained by a blunted responsiveness of skeletal muscle to the anabolic properties of dietary protein and muscle contraction. Therefore, sufficient dietary protein intake and physical activity are required to minimise age-related muscle atrophy. It remains unknown whether this can be achieved utilising non-animal-derived (vegan) protein sources.

Objective: To assess daily muscle protein synthesis rates when adopting a vegan or protein-matched omnivorous control diet.

Methods: Healthy older adults (aged 60-80 years) will be randomly allocated to a completely controlled 1-week vegan (providing 0.8 g/kg BW/day protein) or protein-matched omnivorous diet. During this week, participants will perform a set of unilateral leg resistance exercise on day 1, 3, and 5. Deuterium oxide in combination with saliva and muscle sample (from the m. vastus lateralis) collection will be used to measure daily muscle protein synthesis rates in resting and exercised tissue.

Value: This will be the first study assessing daily muscle protein turnover in healthy older adults adopting a 1-week vegan diet. This will contribute to the understanding and viability of vegan protein to support active and healthy ageing.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Devond
      • Exeter, Devond, United Kingdom, EX1 2LU
        • University of Exeter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vegan diet
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
Participants will adopt a 1-week completely controlled diet and perform 3 sessions of unilateral leg resistance exercise.
Experimental: Omnivorous diet
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
Participants will adopt a 1-week completely controlled diet and perform 3 sessions of unilateral leg resistance exercise.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle protein synthesis (MPS) in resting and exercised tissue
Time Frame: 7 days
Daily MPS rates, expressed as fractional synthetic rate (%/h)
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle morphology
Time Frame: 7 days
Changes in muscle thickness during the intervention period, measured via ultrasound
7 days

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Exeter

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 524790

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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