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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05809466
Acronym
Vold
Enrollment
72
Registered
2023-04-12
Start date
2023-04-04
Completion date
2024-09-26
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vegan Diet, Sarcopenia, Cardiovascular Health, Osteoporosis, Gut Health

Brief 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. 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.

Interventions

OTHERVegan diet

A self-composed 12 week fully plant-based diet

OTHERResistance exercise

Biweekly resistance exercise for 12 weeks

Habitual diet containing both animal- and plant-based food products

Sponsors

Wageningen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in thigh muscle volume12 weeksThigh muscle volume of both legs will be assessed using magnetic resonance imaging before and after the 3-month intervention

Secondary

MeasureTime frameDescription
Body compositionChange after 12 weeksOther 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 in muscle strengthChange after 12 weeksMaximal isometric knee extension and flexion strength of both legs will be measured using Biodex.
Muscle fractional synthesis rates10 daysMuscle 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.
Change in bone mineral densityChange after 12 weeksMeasured using a Dual X-Ray Absorptiometry dual femur scan
Change in fasting bone turnover markersChange after 6 and 12 weeksSerum 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 in plasma insulin growth factor 1 levelsChange after 6 and 12 weeksFasting serum insulin-like growth factor 1 (IGF-1)
Change in plasma parathyroid hormone (PTH) levelsChange after 6 and 12 weeksFasting plasma PTH
Change in fasting plasma insulin levelsChange after 6 and 12 weeksFasting plasma insulin
Change in metabolic profileChange after 6 and 12 weeksFasting plasma levels of multiple metabolites
Change in fasting blood pressureChange after 6 and 12 weeksFasting systolic and diastolic blood pressure
Change in haemoglobin levelsChange after 12 weeksFasting plasma haemoglobin levels
Change in vitamin D statusChange after 12 weeksFasting serum vitamin D levels
Change in gastro-intestinal symptomsChange after 12 weeksSelf-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.
Untargeted gut metabolomicsChange after 12 weeksUntargeted gut metabolomics will be performed on fasting plasma samples
Change in fasting plasma high-sensitive C-reactive protein (hs-CRP)Change after 6 and 12 weeksFasting plasma hs-CRP
Change in ferritin levelsChange after 12 weeksFasting plasma ferritin levels
TryptophanChange after 12 weeksTryptophan will be assessed using targeted metabolomics on plasma samples
TyrosineChange after 12 weeksTyrosine will be assessed using targeted metabolomics on plasma samples
Branch-chained amino acidsChange after 12 weeksBranch-chained amino acids will be assessed using targeted metabolomics on plasma samples
Oxidized amino acidsChange after 12 weeksOxidized amino acids will be assessed using targeted metabolomics on plasma samples
Gut metagenomicsChange after 12 weeksMicrobial 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 in vitamin B12 statusChange after 12 weeksFasting plasma methylmalonic acid levels

Other

MeasureTime frameDescription
Change in body weightChange after 10 days and after 12 weeksBody weight (kg) will be measured in a fasted state using a calibrated digital scale

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026