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The Vold-study: The effect of a 12-week self-composed vegan diet with or without concurrent resistance exercise on thigh muscle volume in older adults

The Vold-study: The effect of a 12-week self-composed vegan diet with or without concurrent resistance exercise on thigh muscle volume in older adults - Vold-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53915
Enrollment
72
Registered
2023-03-23
Start date
2023-04-18
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preventie cardiometabole aandoeningen age-related muscle loss Sarcopenia

Interventions

Self-composed fully plant-based (vegan) diet with or without concurrent RE.

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
65 Years to 99 Years

Inclusion 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

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 (below 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; severe renal disease (glomerular filtration rate below 30 ml/min) ; 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): o Pacemakers and defibrillators o Infraorbital or intraocular metallic fragments o Ferromagnetic implants o Claustrophobia - 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 works 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.

Design outcomes

Primary

MeasureTime frame
The main study parameter is the difference in change in TMV.

Secondary

MeasureTime frame
- Other body composition indices from MRI-scan: thigh muscle fat infiltration, liver proton-density fat fraction, visceral adipose tissue, Abdominal subcutaneous adipose tissue - Muscle strength - Muscle fractional synthesis rates - Bone mineral density - Bone turnover markers (C-terminal telopeptide of type I collagen [CTX] and procollagen type I N-terminal propeptide [PINP]) - Insulin-like growth factor 1 (IGF-1) and parathyroid hormone (PTH) levels - Insulin levels - Dietary intake - Metabolic profile - Blood pressure - Iron status - Vitamin B12 status - Vitamin D status - Gastrointestinal symptoms - Gut metabolomics and metagenomics - High sensitive CRP - DNA methylation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)