The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults (Vold)

March 25, 2025 updated by: Lisette de Groot, Wageningen University
Consumers are increasingly encouraged to consume more plant-based foods and lower their consumption of foods from animal origin. This shift is driven by environmental and health factors. However, the consequences of such a transition on muscle mass still remains to be explored. This is of particular importance in the older population, where the age-related reduction in muscle mass and strength is highly prevalent. Adequate dietary intake, specifically protein intake, is a well-known strategy in promoting muscle mass in older adults. Plant-based foods are currently considered to be inferior to animal-based foods in their protein quality, and are therefore considered to be suboptimal for the maintenance of muscle mass at an older age. On the other hand, combining plant-based foods may improve the protein quality and thereby the anabolic properties of a vegan meal. Evidence regarding the anabolic properties of vegan diets in older adults is scarce. As such, the current study aims to assess 1) the effects of a 12-week self-composed vegan diet in comparison to an omnivorous diet on thigh muscle volume (TMV) in community-dwelling older adults and 2) the effect of a 12-week self-composed vegan diet combined with twice-weekly resistance exercise (RE) on TMV in comparison to a self-composed vegan diet without resistance exercise in community-dwelling older adults.

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.

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.
72

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

  • Netherlands
    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6708 WE
        • Wageningen University and Research

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

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged ≥65 years old;
  • Community-dwelling;
  • BMI 23-32 kg/m2;
  • Habitual diet contains animal-based food products (i.e. dairy, meat and/or fish) at least 5 days per week;

Exclusion Criteria:

  • Following a self-reported entirely vegetarian or vegan diet during the six months prior to the study;
  • Following a prescribed high (≥1.2 g/kg/d) or low protein diet (<0.8 g/kg/d), and/or or taking protein supplements on medical advice, during the month prior to the study;
  • Participating in a structured progressive resistance exercise training program the during three months prior to the study;
  • ≥4 kg of body weight loss during three months before the start of the study;
  • Being diagnosed with one of the following: diabetes mellitus; renal disease; neurological or neuromuscular disorders; serious cardiovascular diseases; cancer (with the exception of the following types of skin cancer: basal cell carcinoma, squamous cell carcinoma); (very) severe chronic obstructive lung disease (COPD; GOLD stage III or IV); bowel disease.
  • Chronic use of medication that affects muscle function as assessed by the research physician;
  • The use of anticoagulants incompatible for muscle biopsies as assessed by the research physician: acenocoumarol (sintrom); phenprocoumon (marcoumar); dabigatran (pradaxa); apixaban (eliquis); rivaroxaban (xarelto); clopidogrel (plavix); edoxaban (lixiana); combination of acetylsalicylic acid or carbasalate calcium (ascal) with dipyridamole;

  • Having a contra-indication to MRI scanning (including, but not limited to):

    • Pacemakers and defibrillators
    • Infraorbital or intraocular metallic fragments
    • Ferromagnetic implants
    • Claustrophobia
  • Having a hip prosthesis
  • Not willing to stop nutritional supplements, with the exception of supplements on medical advice, and vitamin D;
  • Not willing or afraid to give blood, undergo a muscle biopsy or have an MRI scan during the study;
  • Unwilling to eat a self-composed vegan diet or an omnivorous diet with daily consumption of animal-based food sources for 3 months;
  • Unwilling to participate in RE twice a week for 3 months;
  • Currently a research participant in another trial or participated in a clinical trial during one month before the start of the measurement period;
  • Not being able to understand Dutch;
  • Not having a general physician;
  • Working, or having a direct family member that work at the Division of Human Nutrition at Wageningen University during the study.
  • Unwilling to be informed about incidental findings of pathology and approving of reporting this to their general physician.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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 group
Other: Vegan diet
A self-composed 12 week fully plant-based diet
Experimental: Vegan group with resistance exercise
Other: Vegan diet
A self-composed 12 week fully plant-based diet
Other: Resistance exercise
Biweekly resistance exercise for 12 weeks
Active Comparator: Omnivorous group
Other: Omnivorous diet
Habitual diet containing both animal- and plant-based food products

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
Change in thigh muscle volume
Time Frame: 12 weeks
Thigh muscle volume of both legs will be assessed using magnetic resonance imaging before and after the 3-month intervention
12 weeks

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
Body composition
Time Frame: Change after 12 weeks
Other body composition indices will also be measured using magnetic resonance imaging before and after the intervention. These indices include: liver fat fraction, thigh muscle fat infiltration, abdominal subcutaneous adipose tissue, visceral fat tissue.
Change after 12 weeks
Change in muscle strength
Time Frame: Change after 12 weeks
Maximal isometric knee extension and flexion strength of both legs will be measured using Biodex.
Change after 12 weeks
Muscle fractional synthesis rates
Time Frame: 10 days
Muscle fractional synthesis rates, expressed as daily fractional synthesis rates (FSR, %/day), will be assessed using a deuterium oxide protocol. Daily FSR will be calculated using the 2^H-alanine enrichment in plasma and the mixed muscle-bound 2^H-alanine enrichment.
10 days
Change in bone mineral density
Time Frame: Change after 12 weeks
Measured using a Dual X-Ray Absorptiometry dual femur scan
Change after 12 weeks
Change in fasting bone turnover markers
Time Frame: Change after 6 and 12 weeks
Serum procollagen type I N-terminal propeptide (P1NP) will be measured for bone formation and C-terminal telopeptide of type I collagen (CTX) for bone resorption.
Change after 6 and 12 weeks
Change in plasma insulin growth factor 1 levels
Time Frame: Change after 6 and 12 weeks
Fasting serum insulin-like growth factor 1 (IGF-1)
Change after 6 and 12 weeks
Change in plasma parathyroid hormone (PTH) levels
Time Frame: Change after 6 and 12 weeks
Fasting plasma PTH
Change after 6 and 12 weeks
Change in fasting plasma insulin levels
Time Frame: Change after 6 and 12 weeks
Fasting plasma insulin
Change after 6 and 12 weeks
Change in metabolic profile
Time Frame: Change after 6 and 12 weeks
Fasting plasma levels of multiple metabolites
Change after 6 and 12 weeks
Change in fasting blood pressure
Time Frame: Change after 6 and 12 weeks
Fasting systolic and diastolic blood pressure
Change after 6 and 12 weeks
Change in haemoglobin levels
Time Frame: Change after 12 weeks
Fasting plasma haemoglobin levels
Change after 12 weeks
Change in vitamin B12 status
Time Frame: Change after 12 weeks
Fasting plasma methylmalonic acid levels
Change after 12 weeks
Change in vitamin D status
Time Frame: Change after 12 weeks
Fasting serum vitamin D levels
Change after 12 weeks
Change in gastro-intestinal symptoms
Time Frame: Change after 12 weeks
Self-reported gastro-intestinal symptoms using the gastro-intestinal symptom rating scale. The questionnaire includes 15 questions covering 5 common symptom clusters on a 7-point likert scale ranging from no symptoms (minimum) to severe symptoms (maximum). A higher score indicates worse symptoms.
Change after 12 weeks
Untargeted gut metabolomics
Time Frame: Change after 12 weeks
Untargeted gut metabolomics will be performed on fasting plasma samples
Change after 12 weeks
Change in fasting plasma high-sensitive C-reactive protein (hs-CRP)
Time Frame: Change after 6 and 12 weeks
Fasting plasma hs-CRP
Change after 6 and 12 weeks
Change in ferritin levels
Time Frame: Change after 12 weeks
Fasting plasma ferritin levels
Change after 12 weeks
Tryptophan
Time Frame: Change after 12 weeks
Tryptophan will be assessed using targeted metabolomics on plasma samples
Change after 12 weeks
Tyrosine
Time Frame: Change after 12 weeks
Tyrosine will be assessed using targeted metabolomics on plasma samples
Change after 12 weeks
Branch-chained amino acids
Time Frame: Change after 12 weeks
Branch-chained amino acids will be assessed using targeted metabolomics on plasma samples
Change after 12 weeks
Oxidized amino acids
Time Frame: Change after 12 weeks
Oxidized amino acids will be assessed using targeted metabolomics on plasma samples
Change after 12 weeks
Gut metagenomics
Time Frame: Change after 12 weeks
Microbial DNA will be isolated from the feces samples. The taxonomy and function of specific genes will be assessed via metagenomic sequencing on the microbial DNA.
Change after 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: Change after 10 days and after 12 weeks
Body weight (kg) will be measured in a fasted state using a calibrated digital scale
Change after 10 days and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisette de Groot, PhD, Wageningen University and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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.
April 4, 2023

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.
September 26, 2024

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.
September 26, 2024

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).
March 14, 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.
March 29, 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.
April 12, 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 1, 2025

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.
March 25, 2025

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.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • NL82788.091.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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