The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in thigh muscle volume
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
Change in thigh muscle volume
时间窗: 12 weeks
Thigh muscle volume of both legs will be assessed using magnetic resonance imaging before and after the 3-month intervention
次要结局
- Untargeted gut metabolomics(Change after 12 weeks)
- Change in fasting plasma high-sensitive C-reactive protein (hs-CRP)(Change after 6 and 12 weeks)
- Change in bone mineral density(Change after 12 weeks)
- Change in haemoglobin levels(Change after 12 weeks)
- Change in vitamin B12 status(Change after 12 weeks)
- Change in ferritin levels(Change after 12 weeks)
- Change in plasma insulin growth factor 1 levels(Change after 6 and 12 weeks)
- Change in metabolic profile(Change after 6 and 12 weeks)
- Change in fasting bone turnover markers(Change after 6 and 12 weeks)
- Change in fasting blood pressure(Change after 6 and 12 weeks)
- Branch-chained amino acids(Change after 12 weeks)
- Body composition(Change after 12 weeks)
- Change in muscle strength(Change after 12 weeks)
- Muscle fractional synthesis rates(10 days)
- Change in plasma parathyroid hormone (PTH) levels(Change after 6 and 12 weeks)
- Change in fasting plasma insulin levels(Change after 6 and 12 weeks)
- Change in vitamin D status(Change after 12 weeks)
- Change in gastro-intestinal symptoms(Change after 12 weeks)
- Tryptophan(Change after 12 weeks)
- Oxidized amino acids(Change after 12 weeks)
- Tyrosine(Change after 12 weeks)
- Gut metagenomics(Change after 12 weeks)
研究者
Lisette de Groot
Prof. Dr. Ir. L.C.P.G.M. (Lisette) de Groot
Wageningen University