Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.
VD2O
3 other identifiers
interventional
38
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
November 8, 2022
CompletedFirst Posted
Study publicly available on registry
November 22, 2022
CompletedStudy Start
First participant enrolled
January 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2023
CompletedMarch 24, 2023
March 1, 2023
1 month
November 8, 2022
March 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
10 days
Secondary Outcomes (5)
Appetite
Measured daily for 10 days during each diet
Change in fasting plasma glucose
Change after 10 days of following each diet
Change in fasting plasma insulin
Change after 10 days of following each diet
Change in fasting plasma lipid profile
Change after 10 days of following each diet
Change in blood pressure
Change after 10 days of following each diet
Study Arms (2)
VO group
OTHERVegan diet followed by Omnivorous diet
OV group
OTHEROmnivorous diet followed by Vegan diet
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Aged 65-79 years old;
- Community-dwelling;
- BMI 20-35 kg/m\^2.
You may not qualify if:
- 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;
- % 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Universitylead
- Rijksoverheidcollaborator
- Maastricht Universitycollaborator
Study Sites (1)
Wageningen University and Research
Wageningen, Gelderland, 6708 WE, Netherlands
Related Publications (1)
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.
PMID: 39732437DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisette de Groot
Wageningen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Ir. L.C.P.G.M. (Lisette) de Groot
Study Record Dates
First Submitted
November 8, 2022
First Posted
November 22, 2022
Study Start
January 9, 2023
Primary Completion
February 13, 2023
Study Completion
February 13, 2023
Last Updated
March 24, 2023
Record last verified: 2023-03