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

Osteoporosis Clinical Trial

— Vold  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809466
• Other study ID #: NL82788.091.22
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2024
• Source: Wageningen University
• Contact: Lisette de Groot, PhD
• Phone: +31 317 48 80 77
• Email: lisette.degroot[@]wur.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Health
• Gut Health
• Osteoporosis
• Sarcopenia
• Vegan Diet

Intervention

Other:
• Vegan diet
A self-composed 12 week fully plant-based diet
• Resistance exercise
Biweekly resistance exercise for 12 weeks
• Omnivorous diet
Habitual diet containing both animal- and plant-based food products

Locations

Country	Name	City	State
Netherlands	Wageningen University and Research	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in body weight	Body weight (kg) will be measured in a fasted state using a calibrated digital scale	Change after 10 days and after 12 weeks
Primary	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	Body composition	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.	Change after 12 weeks
Secondary	Change in muscle strength	Maximal isometric knee extension and flexion strength of both legs will be measured using Biodex.	Change after 12 weeks
Secondary	Muscle fractional synthesis rates	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.	10 days
Secondary	Change in bone mineral density	Measured using a Dual X-Ray Absorptiometry dual femur scan	Change after 12 weeks
Secondary	Change in fasting bone turnover markers	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.	Change after 6 and 12 weeks
Secondary	Change in plasma insulin growth factor 1 levels	Fasting serum insulin-like growth factor 1 (IGF-1)	Change after 6 and 12 weeks
Secondary	Change in plasma parathyroid hormone (PTH) levels	Fasting plasma PTH	Change after 6 and 12 weeks
Secondary	Change in fasting plasma insulin levels	Fasting plasma insulin	Change after 6 and 12 weeks
Secondary	Change in metabolic profile	Fasting plasma levels of multiple metabolites	Change after 6 and 12 weeks
Secondary	Change in fasting blood pressure	Fasting systolic and diastolic blood pressure	Change after 6 and 12 weeks
Secondary	Change in haemoglobin levels	Fasting plasma haemoglobin levels	Change after 12 weeks
Secondary	Change in vitamin B12 status	Fasting plasma methylmalonic acid levels	Change after 12 weeks
Secondary	Change in vitamin D status	Fasting serum vitamin D levels	Change after 12 weeks
Secondary	Change in gastro-intestinal symptoms	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.	Change after 12 weeks
Secondary	Untargeted gut metabolomics	Untargeted gut metabolomics will be performed on fasting plasma samples	Change after 12 weeks
Secondary	Change in fasting plasma high-sensitive C-reactive protein (hs-CRP)	Fasting plasma hs-CRP	Change after 6 and 12 weeks
Secondary	Change in ferritin levels	Fasting plasma ferritin levels	Change after 12 weeks
Secondary	Tryptophan	Tryptophan will be assessed using targeted metabolomics on plasma samples	Change after 12 weeks
Secondary	Tyrosine	Tyrosine will be assessed using targeted metabolomics on plasma samples	Change after 12 weeks
Secondary	Branch-chained amino acids	Branch-chained amino acids will be assessed using targeted metabolomics on plasma samples	Change after 12 weeks
Secondary	Oxidized amino acids	Oxidized amino acids will be assessed using targeted metabolomics on plasma samples	Change after 12 weeks
Secondary	Gut metagenomics	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.	Change after 12 weeks