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

NCT05809466 | Completed

• 1 other identifier: NL82788.091.22
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Vegan Diet; Sarcopenia; Cardiovascular Health; Osteoporosis; Gut Health

Outcome Measures

Primary Outcomes (1)

• Change in thigh muscle volume

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

  12 weeks

Secondary Outcomes (22)

• Body composition

  Change after 12 weeks

• Change in muscle strength

  Change after 12 weeks

• Muscle fractional synthesis rates

  10 days

• Change in bone mineral density

  Change after 12 weeks

• Change in fasting bone turnover markers

  Change after 6 and 12 weeks

Other Outcomes (1)

• Change in body weight

  Change after 10 days and after 12 weeks

Study Arms (3)

Vegan group

EXPERIMENTAL

Other: Vegan diet

Vegan group with resistance exercise

EXPERIMENTAL

Other: Vegan diet; Other: Resistance exercise

Omnivorous group

ACTIVE COMPARATOR

Other: Omnivorous diet

Interventions

Vegan diet OTHER

A self-composed 12 week fully plant-based diet

Vegan group; Vegan group with resistance exercise

Resistance exercise OTHER

Biweekly resistance exercise for 12 weeks

Vegan group with resistance exercise

Omnivorous diet OTHER

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

Omnivorous group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University and Research

Wageningen, Gelderland, 6708 WE, Netherlands

Location

Related Publications (1)

• Domic J, Grootswagers P, Pinckaers PJ, Groenendijk I, Rubert J, van Loon LJ, de Groot LC. The effect of a vegan diet with or without resistance exercise on thigh muscle volume in older adults. Research protocol of the Vold-study: a 12-week randomized controlled trial. BMC Geriatr. 2025 Dec 26;26(1):120. doi: 10.1186/s12877-025-06708-9.

  PMID: 41454225 DERIVED

MeSH Terms

Conditions

Sarcopenia; Osteoporosis

Interventions

Diet, Vegan; Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lisette de Groot, PhD

  Wageningen University and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Ir. L.C.P.G.M. (Lisette) de Groot

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 12, 2023
• Study Start: April 4, 2023
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: April 1, 2025

Record last verified: 2024-11

Locations

NL (1)