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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05809466
Other study ID # NL82788.091.22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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