Wageningen University and Research
Wageningen, Gelderland, 6708 WE, Netherlands
NCT Number: NCT05809466
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Wageningen, Gelderland, 6708 WE, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A self-composed 12 week fully plant-based diet
Biweekly resistance exercise for 12 weeks
Habitual diet containing both animal- and plant-based food products
Time frame: 12 weeks
Thigh muscle volume of both legs will be assessed using magnetic resonance imaging before and after the 3-month intervention
Time frame: Change after 12 weeks
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.
Time frame: Change after 12 weeks
Maximal isometric knee extension and flexion strength of both legs will be measured using Biodex.
Time frame: 10 days
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.
Time frame: Change after 12 weeks
Measured using a Dual X-Ray Absorptiometry dual femur scan
Time frame: Change after 6 and 12 weeks
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.
Time frame: Change after 6 and 12 weeks
Fasting serum insulin-like growth factor 1 (IGF-1)
Time frame: Change after 6 and 12 weeks
Fasting plasma PTH
Time frame: Change after 6 and 12 weeks
Fasting plasma insulin
Time frame: Change after 6 and 12 weeks
Fasting plasma levels of multiple metabolites
Time frame: Change after 6 and 12 weeks
Fasting systolic and diastolic blood pressure
Time frame: Change after 12 weeks
Fasting plasma haemoglobin levels
Time frame: Change after 12 weeks
Fasting plasma methylmalonic acid levels
Time frame: Change after 12 weeks
Fasting serum vitamin D levels
Time frame: Change after 12 weeks
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.
Time frame: Change after 12 weeks
Untargeted gut metabolomics will be performed on fasting plasma samples
Time frame: Change after 6 and 12 weeks
Fasting plasma hs-CRP
Time frame: Change after 12 weeks
Fasting plasma ferritin levels
Time frame: Change after 12 weeks
Tryptophan will be assessed using targeted metabolomics on plasma samples
Time frame: Change after 12 weeks
Tyrosine will be assessed using targeted metabolomics on plasma samples
Time frame: Change after 12 weeks
Branch-chained amino acids will be assessed using targeted metabolomics on plasma samples
Time frame: Change after 12 weeks
Oxidized amino acids will be assessed using targeted metabolomics on plasma samples
Time frame: Change after 12 weeks
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.
Time frame: Change after 10 days and after 12 weeks
Body weight (kg) will be measured in a fasted state using a calibrated digital scale
Wageningen University
Other
Acronym: Vold
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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