Osteoporosis Clinical Trial
— VoldOfficial title:
The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults
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.
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University and Research | Wageningen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Wageningen University |
Netherlands,
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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