Vegan DietVoldNCT05809466
The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults
A study testing Vegan diet, Resistance exercise and Omnivorous diet in people with Vegan Diet and Sarcopenia, run by Wageningen University at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vegan Diet, Sarcopenia, Cardiovascular Health
- What is being tested?
- Vegan diet, Resistance exercise and Omnivorous diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Apr 2023to 26 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University and Research
Wageningen, Gelderland, 6708 WE
About this study
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.
- Conditions
- Vegan Diet, Sarcopenia, Cardiovascular Health, Osteoporosis, Gut Health
- Being tested
- Vegan diet, Resistance exercise, Omnivorous diet
- Medical subject headings
- Sarcopenia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegan dietOther
A self-composed 12 week fully plant-based diet
Resistance exerciseOther
Biweekly resistance exercise for 12 weeks
Omnivorous dietOther
Habitual diet containing both animal- and plant-based food products
| Study group | Role | What they receive |
|---|---|---|
| Vegan group | Experimental | Not described Receives: Other: Vegan diet |
| Vegan group with resistance exercise | Experimental | Not described Receives: Other: Vegan diet; Other: Resistance exercise |
| Omnivorous group | Active comparator | Not described Receives: Other: Omnivorous diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in thigh muscle volume
Thigh muscle volume of both legs will be assessed using magnetic resonance imaging before and after the 3-month intervention
Measured: 12 weeks
Secondary outcomes (22)
Body composition
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.
Measured: Change after 12 weeks
Change in muscle strength
Maximal isometric knee extension and flexion strength of both legs will be measured using Biodex.
Measured: Change after 12 weeks
Muscle fractional synthesis rates
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.
Measured: 10 days
Change in bone mineral density
Measured using a Dual X-Ray Absorptiometry dual femur scan
Measured: Change after 12 weeks
Change in fasting bone turnover markers
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.
Measured: Change after 6 and 12 weeks
Change in plasma insulin growth factor 1 levels
Fasting serum insulin-like growth factor 1 (IGF-1)
Measured: Change after 6 and 12 weeks
Change in plasma parathyroid hormone (PTH) levels
Fasting plasma PTH
Measured: Change after 6 and 12 weeks
Change in fasting plasma insulin levels
Fasting plasma insulin
Measured: Change after 6 and 12 weeks
Change in metabolic profile
Fasting plasma levels of multiple metabolites
Measured: Change after 6 and 12 weeks
Change in fasting blood pressure
Fasting systolic and diastolic blood pressure
Measured: Change after 6 and 12 weeks
Change in haemoglobin levels
Fasting plasma haemoglobin levels
Measured: Change after 12 weeks
Change in vitamin B12 status
Fasting plasma methylmalonic acid levels
Measured: Change after 12 weeks
Change in vitamin D status
Fasting serum vitamin D levels
Measured: Change after 12 weeks
Change in gastro-intestinal symptoms
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.
Measured: Change after 12 weeks
Untargeted gut metabolomics
Untargeted gut metabolomics will be performed on fasting plasma samples
Measured: Change after 12 weeks
Change in fasting plasma high-sensitive C-reactive protein (hs-CRP)
Fasting plasma hs-CRP
Measured: Change after 6 and 12 weeks
Change in ferritin levels
Fasting plasma ferritin levels
Measured: Change after 12 weeks
Tryptophan
Tryptophan will be assessed using targeted metabolomics on plasma samples
Measured: Change after 12 weeks
Tyrosine
Tyrosine will be assessed using targeted metabolomics on plasma samples
Measured: Change after 12 weeks
Branch-chained amino acids
Branch-chained amino acids will be assessed using targeted metabolomics on plasma samples
Measured: Change after 12 weeks
Oxidized amino acids
Oxidized amino acids will be assessed using targeted metabolomics on plasma samples
Measured: Change after 12 weeks
Gut metagenomics
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.
Measured: Change after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start4 Apr 2023
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vegan DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisette de Groot, Wageningen University
- Investigators
- Lisette de Groot, PhD, Principal investigator, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809466
- Sponsor's protocol ID
- NL82788.091.22
- Acronym
- Vold
- Status last verified
- Nov 2024
- First submitted
- 14 Mar 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Domic J, Grootswagers P, Pinckaers PJ, Melchers M, van Loon LJ, de Groot LC. A self-selected vegan diet reduces skeletal muscle mass in healthy older adults: a randomized controlled trial. Am J Clin Nutr. 2026 Sep;124(3):101416. doi: 10.1016/j.ajcnut.2026.101416. Epub 2026 Aug 14.
PubMed 42680254Domic J, Grootswagers P, Pinckaers PJ, Groenendijk I, Rubert J, van Loon LJ, de Groot LC. The effect of a vegan diet with or without resistance exercise on thigh muscle volume in older adults. Research protocol of the Vold-study: a 12-week randomized controlled trial. BMC Geriatr. 2025 Dec 26;26(1):120. doi: 10.1186/s12877-025-06708-9.
PubMed 41454225
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults
- ClinicalTrials.gov ID
- NCT05809466
- Acronym / sponsor ID
- Vold / NL82788.091.22
- Conditions
- Vegan Diet, Sarcopenia, Cardiovascular Health, Osteoporosis, Gut Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vegan group | Experimental | Other: Vegan diet |
| Vegan group with resistance exercise | Experimental | Other: Vegan diet, Other: Resistance exercise |
| Omnivorous group | Active comparator | Other: Omnivorous diet |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegan dietA self-composed 12 week fully plant-based diet | Other | Vegan group, Vegan group with resistance exercise |
| Resistance exerciseBiweekly resistance exercise for 12 weeks | Other | Vegan group with resistance exercise |
| Omnivorous dietHabitual diet containing both animal- and plant-based food products | Other | Omnivorous group |
Primary outcome
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
22 secondary outcomes
Body composition
Time frame: Change after 12 weeks
Change in muscle strength
Time frame: Change after 12 weeks
Muscle fractional synthesis rates
Time frame: 10 days
Change in bone mineral density
Time frame: Change after 12 weeks
Change in fasting bone turnover markers
Time frame: Change after 6 and 12 weeks
Change in plasma insulin growth factor 1 levels
Time frame: Change after 6 and 12 weeks
Change in plasma parathyroid hormone (PTH) levels
Time frame: Change after 6 and 12 weeks
Change in fasting plasma insulin levels
Time frame: Change after 6 and 12 weeks
Change in metabolic profile
Time frame: Change after 6 and 12 weeks
Change in fasting blood pressure
Time frame: Change after 6 and 12 weeks
Change in haemoglobin levels
Time frame: Change after 12 weeks
Change in vitamin B12 status
Time frame: Change after 12 weeks
Change in vitamin D status
Time frame: Change after 12 weeks
Change in gastro-intestinal symptoms
Time frame: Change after 12 weeks
Untargeted gut metabolomics
Time frame: Change after 12 weeks
Change in fasting plasma high-sensitive C-reactive protein (hs-CRP)
Time frame: Change after 6 and 12 weeks
Change in ferritin levels
Time frame: Change after 12 weeks
Tryptophan
Time frame: Change after 12 weeks
Tyrosine
Time frame: Change after 12 weeks
Branch-chained amino acids
Time frame: Change after 12 weeks
Oxidized amino acids
Time frame: Change after 12 weeks
Gut metagenomics
Time frame: Change after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Derived from this study: PubMed 42680254Domic J, Grootswagers P, Pinckaers PJ, Melchers M, van Loon LJ, de Groot LC. A self-selected vegan diet reduces skeletal muscle mass in healthy older adults: a randomized controlled trial. Am J Clin Nutr. 2026 Sep;124(3):101416. doi: 10.1016/j.ajcnut.2026.101416. Epub 2026 Aug 14.
- Derived from this study: PubMed 41454225Domic J, Grootswagers P, Pinckaers PJ, Groenendijk I, Rubert J, van Loon LJ, de Groot LC. The effect of a vegan diet with or without resistance exercise on thigh muscle volume in older adults. Research protocol of the Vold-study: a 12-week randomized controlled trial. BMC Geriatr. 2025 Dec 26;26(1):120. doi: 10.1186/s12877-025-06708-9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisette de Groot, PhD principal investigator
Wageningen University and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegan diet, Resistance exercise and Omnivorous diet in people with Vegan Diet and Sarcopenia, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in thigh muscle volume (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809466, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.