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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 (Vold)

W

Wageningen University

Status

Completed

Conditions

Osteoporosis
Cardiovascular Health
Vegan Diet
Gut Health
Sarcopenia

Treatments

Other: Omnivorous diet
Other: Vegan diet
Other: Resistance exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05809466
NL82788.091.22

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 3 patient groups

Vegan group
Experimental group
Treatment:
Other: Vegan diet
Vegan group with resistance exercise
Experimental group
Treatment:
Other: Resistance exercise
Other: Vegan diet
Omnivorous group
Active Comparator group
Treatment:
Other: Omnivorous diet

Trial contacts and locations

1

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Central trial contact

Jacintha Domić, MSc; Lisette de Groot, PhD

Data sourced from clinicaltrials.gov

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