NCT05809466Completed
The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 14 Mar 2023
- Start date
- 4 Apr 2023
- Primary completion date
- 26 Sept 2024
- Lead sponsor
- Wageningen University
- Diseases
- Osteoporosis
- NCT number
- NCT05809466
What you commit to
- Study type: Interventional
- Participants enrolled: 72
- From 4 Apr 2023 to the primary completion date, 26 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Chronic use of medication that affects muscle function as assessed by the research physician;
- Having a contra-indication to MRI scanning (including, but not limited to):
- Pacemakers and defibrillators
- Infraorbital or intraocular metallic fragments
- Ferromagnetic implants
- Claustrophobia
- Currently a research participant in another trial or participated in a clinical trial during one month before the start of the measurement period;
Other illness
- 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.
Lab values
- 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;
Other
- 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;
- 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.
Who the study is looking for
- 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;
Age in the registry: 65 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wageningen University and Research Coordinator of this site? Confirm its status | Wageningen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.