Clinical trial NCT05809466: The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults
Official title: The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vegan Diet
Sarcopenia
Cardiovascular Health
Osteoporosis
Gut Health
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 72
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in thigh muscle volume
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition
timeFrame: Change after 12 weeks
measure: Change in muscle strength
timeFrame: Change after 12 weeks
measure: Muscle fractional synthesis rates
timeFrame: 10 days
measure: Change in bone mineral density
timeFrame: Change after 12 weeks
measure: Change in fasting bone turnover markers
timeFrame: Change after 6 and 12 weeks
measure: Change in plasma insulin growth factor 1 levels
timeFrame: Change after 6 and 12 weeks
measure: Change in plasma parathyroid hormone (PTH) levels
timeFrame: Change after 6 and 12 weeks
measure: Change in fasting plasma insulin levels
timeFrame: Change after 6 and 12 weeks
measure: Change in metabolic profile
timeFrame: Change after 6 and 12 weeks
measure: Change in fasting blood pressure
timeFrame: Change after 6 and 12 weeks
measure: Change in haemoglobin levels
timeFrame: Change after 12 weeks
measure: Change in vitamin B12 status
timeFrame: Change after 12 weeks
measure: Change in vitamin D status
timeFrame: Change after 12 weeks
measure: Change in gastro-intestinal symptoms
timeFrame: Change after 12 weeks
measure: Untargeted gut metabolomics
timeFrame: Change after 12 weeks
measure: Change in fasting plasma high-sensitive C-reactive protein (hs-CRP)
timeFrame: Change after 6 and 12 weeks
measure: Change in ferritin levels
timeFrame: Change after 12 weeks
measure: Tryptophan
timeFrame: Change after 12 weeks
measure: Tyrosine
timeFrame: Change after 12 weeks
measure: Branch-chained amino acids
timeFrame: Change after 12 weeks
measure: Oxidized amino acids
timeFrame: Change after 12 weeks
measure: Gut metagenomics
timeFrame: Change after 12 weeks
Other outcomes:
measure: Change in body weight
timeFrame: Change after 10 days and after 12 weeks
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University and Research
state: Gelderland
Study officials:
affiliation: Wageningen University and Research
name: Lisette de Groot, PhD
role: PRINCIPAL_INVESTIGATOR
References: