SarcopeniaVD2ONCT05624333
Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.
A study testing Vegan diet (intervention) in people with 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. 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 sarcopenia is highly prevalent. Read more about this study
- Who is it for?
- Ages 65 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Vegan diet (intervention)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Jan 2023to 13 Feb 2023
- 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65-79 years old;
- Community-dwelling;
- BMI 20-35 kg/m^2.
Who cannot join
- Following a vegetarian or vegan diet during the six months prior to the study;
- Following a diet that affects protein intake during the six months prior to the study;
- Participating in a structured exercise training program in the past three months;
- 5% or more body weight loss during three months before the start of the study;
- Being diagnosed with one of the following: diabetes; renal disease; neurological or neuromuscular disorders; serious cardiovascular diseases; cancer; chronic obstructive lung disease (COPD);
- Chronic use of medication that affects muscle function, e.g. corticosteroids, metformin, insulin;
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- The use of the following medicines: acenocoumarol (sintrom); phenprocoumon (marcoumar); dabigatran (pradaxa); apixaban (eliquis); rivaroxaban (xarelto); clopidogrel (plavix); combination of acetylsalicylic acid or carbasalate calcium (ascal) with dipyridamole.
- Allergic or intolerant to any product included in the diets;
- Not willing to stop nutritional supplements, with the exception of supplements on medical advice, and vitamin D;
- Not willing or afraid to give blood or undergo a muscle biopsy during the study;
- Unwilling to eat a vegan and an omnivorous diet for ten days each;
- Currently a research participant in another trial or participated in a clinical trial during three months before the start of the measurement period;
- Not being able to understand Dutch;
- Not having a 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. 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 sarcopenia is highly prevalent. The aim of this randomized controlled cross-over study is to investigate the short-term effect of a 10-day controlled vegan diet on daily muscle fractional synthesis rates in comparison to a 10-day controlled omnivorous diet in 35 community-dwelling older adults.
Participants will follow a fully controlled vegan diet, directly followed by a fully controlled omnivorous diet for 10 days, or vice versa. Researchers will compare the effect of the vegan diet to the effect of the omnivorous diet.
- Conditions
- Sarcopenia
- Being tested
- Vegan diet (intervention), Omnivorous diet (control)
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegan diet (intervention)Other
The intervention diet will be a fully controlled vegan diet that will be consumed for a duration of 10 days. No animal-based food products will be included in the diet.
Omnivorous diet (control)Other
The control diet will be an a priori composed controlled omnivorous diet with a duration of 10 days. The omnivorous diet and the vegan diet will be isocaloric and isonitrogenous.
| Study group | Role | What they receive |
|---|---|---|
| VO group | Other | Vegan diet followed by Omnivorous diet Receives: Other: Vegan diet (intervention); Other: Omnivorous diet (control) |
| OV group | Other | Omnivorous diet followed by Vegan diet Receives: Other: Vegan diet (intervention); Other: Omnivorous diet (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Protein Synthesis (MPS)
MPS, 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
Secondary outcomes (5)
Appetite
Appetite will be assessed using visual analogue scales (VAS; Min 0 mm - max 100 mm) before and after the warm meal. Five VAS-scales regarding hunger, fullness, satiation, desire to eat and prospective food consumption will be used to assess appetite.
Measured: Measured daily for 10 days during each diet
Change in fasting plasma glucose
Fasting plasma glucose levels
Measured: Change after 10 days of following each diet
Change in fasting plasma insulin
Fasting plasma insulin levels
Measured: Change after 10 days of following each diet
Change in fasting plasma lipid profile
Triglycerides, high-density lipoprotein-cholesterol, low-density lipoprotein cholesterol, total cholesterol
Measured: Change after 10 days of following each diet
Change in blood pressure
Fasting systolic and diastolic blood pressure
Measured: Change after 10 days of following each diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start9 Jan 2023
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Rijksoverheid, Maastricht University
- Responsible party
- Principal investigator, Lisette de Groot, Wageningen University
- Investigators
- Lisette de Groot, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624333
- Sponsor's protocol ID
- NL82653.028.22
- Other IDs
- NL9542, NL76916.028.21
- Acronym
- VD2O
- Status last verified
- Mar 2023
- First submitted
- 8 Nov 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Domic J, Pinckaers PJ, Grootswagers P, Siebelink E, Gerdessen JC, van Loon LJ, de Groot LC. A Well-Balanced Vegan Diet Does not Compromise Daily Mixed Muscle Protein Synthesis Rates when Compared with an Omnivorous Diet in Active Older Adults: A Randomized Controlled Cross-Over Trial. J Nutr. 2025 Apr;155(4):1141-1150. doi: 10.1016/j.tjnut.2024.12.019. Epub 2024 Dec 26.
PubMed 39732437
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.
- ClinicalTrials.gov ID
- NCT05624333
- Acronym / sponsor ID
- VD2O / NL82653.028.22
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Rijksoverheid, Maastricht University
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 22 Nov 2022 (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. 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 sarcopenia is highly prevalent. The aim of this randomized controlled cross-over study is to investigate the short-term effect of a 10-day controlled vegan diet on daily muscle fractional synthesis rates in comparison to a 10-day controlled omnivorous diet in 35 community-dwelling older adults.
Participants will follow a fully controlled vegan diet, directly followed by a fully controlled omnivorous diet for 10 days, or vice versa. Researchers will compare the effect of the vegan diet to the effect of the omnivorous diet.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VO group | Other | Other: Vegan diet (intervention), Other: Omnivorous diet (control)Vegan diet followed by Omnivorous diet |
| OV group | Other | Other: Vegan diet (intervention), Other: Omnivorous diet (control)Omnivorous diet followed by Vegan diet |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65-79 years old;
- Community-dwelling;
- BMI 20-35 kg/m^2.
Key exclusion criteria (14 listed)
- Following a vegetarian or vegan diet during the six months prior to the study;
- Following a diet that affects protein intake during the six months prior to the study;
- Participating in a structured exercise training program in the past three months;
- 5% or more body weight loss during three months before the start of the study;
- Being diagnosed with one of the following: diabetes; renal disease; neurological or neuromuscular disorders; serious cardiovascular diseases; cancer; chronic obstructive lung disease (COPD);
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 diet (intervention)The intervention diet will be a fully controlled vegan diet that will be consumed for a duration of 10 days. No animal-based food products will be included in the diet. | Other | OV group, VO group |
| Omnivorous diet (control)The control diet will be an a priori composed controlled omnivorous diet with a duration of 10 days. The omnivorous diet and the vegan diet will be isocaloric and isonitrogenous. | Other | OV group, VO group |
Primary outcome
Muscle Protein Synthesis (MPS)
Time frame: 10 days
MPS, 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.
5 secondary outcomes
Appetite
Time frame: Measured daily for 10 days during each diet
Change in fasting plasma glucose
Time frame: Change after 10 days of following each diet
Change in fasting plasma insulin
Time frame: Change after 10 days of following each diet
Change in fasting plasma lipid profile
Time frame: Change after 10 days of following each diet
Change in blood pressure
Time frame: Change after 10 days of following each diet
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 24 Mar 2023.
- Derived from this study: PubMed 39732437Domic J, Pinckaers PJ, Grootswagers P, Siebelink E, Gerdessen JC, van Loon LJ, de Groot LC. A Well-Balanced Vegan Diet Does not Compromise Daily Mixed Muscle Protein Synthesis Rates when Compared with an Omnivorous Diet in Active Older Adults: A Randomized Controlled Cross-Over Trial. J Nutr. 2025 Apr;155(4):1141-1150. doi: 10.1016/j.tjnut.2024.12.019. Epub 2024 Dec 26.
- 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 principal investigator
Wageningen University
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 (intervention) in people with 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 3 inclusion and 14 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 24 Mar 2023. 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?
Muscle Protein Synthesis (MPS) (time frame: 10 days). 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 NCT05624333, which also lists 1 linked publication.
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 24 Mar 2023.