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Completed

NCT Number: NCT05809466

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

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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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vegan Diet

Other

A self-composed 12 week fully plant-based diet

Resistance Exercise

Other

Biweekly resistance exercise for 12 weeks

Omnivorous diet

Other

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

Primary outcomes

  1. Change in thigh muscle volume

    Time frame: 12 weeks

    Thigh muscle volume of both legs will be assessed using magnetic resonance imaging before and after the 3-month intervention

Secondary outcomes

  1. Body composition

    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.

  2. Change in muscle strength

    Time frame: Change after 12 weeks

    Maximal isometric knee extension and flexion strength of both legs will be measured using Biodex.

  3. Muscle fractional synthesis rates

    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.

  4. Change in bone mineral density

    Time frame: Change after 12 weeks

    Measured using a Dual X-Ray Absorptiometry dual femur scan

  5. Change in fasting bone turnover markers

    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.

  6. Change in plasma insulin growth factor 1 levels

    Time frame: Change after 6 and 12 weeks

    Fasting serum insulin-like growth factor 1 (IGF-1)

  7. Change in plasma parathyroid hormone (PTH) levels

    Time frame: Change after 6 and 12 weeks

    Fasting plasma PTH

  8. Change in fasting plasma insulin levels

    Time frame: Change after 6 and 12 weeks

    Fasting plasma insulin

  9. Change in metabolic profile

    Time frame: Change after 6 and 12 weeks

    Fasting plasma levels of multiple metabolites

  10. Change in fasting blood pressure

    Time frame: Change after 6 and 12 weeks

    Fasting systolic and diastolic blood pressure

  11. Change in haemoglobin levels

    Time frame: Change after 12 weeks

    Fasting plasma haemoglobin levels

  12. Change in vitamin B12 status

    Time frame: Change after 12 weeks

    Fasting plasma methylmalonic acid levels

  13. Change in vitamin D status

    Time frame: Change after 12 weeks

    Fasting serum vitamin D levels

  14. Change in gastro-intestinal symptoms

    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.

  15. Untargeted gut metabolomics

    Time frame: Change after 12 weeks

    Untargeted gut metabolomics will be performed on fasting plasma samples

  16. Change in fasting plasma high-sensitive C-reactive protein (hs-CRP)

    Time frame: Change after 6 and 12 weeks

    Fasting plasma hs-CRP

  17. Change in ferritin levels

    Time frame: Change after 12 weeks

    Fasting plasma ferritin levels

  18. Tryptophan

    Time frame: Change after 12 weeks

    Tryptophan will be assessed using targeted metabolomics on plasma samples

  19. Tyrosine

    Time frame: Change after 12 weeks

    Tyrosine will be assessed using targeted metabolomics on plasma samples

  20. Branch-chained amino acids

    Time frame: Change after 12 weeks

    Branch-chained amino acids will be assessed using targeted metabolomics on plasma samples

  21. Oxidized amino acids

    Time frame: Change after 12 weeks

    Oxidized amino acids will be assessed using targeted metabolomics on plasma samples

  22. Gut metagenomics

    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.

Other outcomes

  1. Change in body weight

    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

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Acronym: Vold

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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