Effects of L-arginine and Liposomal Vitamin C Supplementation on Physical Performance and Endothelial Function in Elderly With Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 6MWT
研究概览
简要总结
In older age, reduced mobility is associated with an increased risk of reduced quality of life, disability, institutionalisation, and death, as well as increased healthcare expenditures. Sarcopenia is a condition characterised by a reduction in muscle mass and strength and/or function. It is associated with several adverse outcomes, such as falls, increased risk of infection, disability, institutionalisation, and death. Currently, no pharmacological treatments are available to combat sarcopenia. The management of sarcopenia relies on the adoption of an active lifestyle, comprising resistance exercise, which may be supported by an adequate intake of protein with the diet. Recently, treatment with L-arginine and liposomal vitamin C has been shown to significantly reduce fatigue, and improve physical performance and endothelial reactivity in adult patients with Long COVID. Long COVID may be considered a model of accelerated ageing, as it recapitulates several age-associated biological processes, including chronic inflammation, oxidative stress, endothelial dysfunction and malnutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •probable sarcopenia defined according to EWGSOP2 criteria
排除标准
- •Inability or unwillingness to provide informed consent;
- •NH residents;
- •schizophrenia or other psychotic disorders, bipolar syndrome;
- •consumption of more than 14 alcoholic beverages per week;
- •reduced cognitive performance (Mini-Mental State Examination score <26);
- •severe arthrosis;
- •malignancies requiring treatment in the previous 3 years;
- •lung disease requiring chronic corticosteroid therapy or oxygen therapy;
- •severe cardiovascular disease;
- •Parkinson's disease or other developmental neurological disorders;
- •renal failure undergoing dialysis treatment;
- •chest pain, severe dyspnea or conditions that may pose safety concerns when performing the 6-minute test or chair test;
- •other medical, psychiatric or behavioral factors that, in the judgment of the researcher, may interfere with participation in the study;
- •other illnesses related to an estimated life expectancy of less than 12 months.
研究组 & 干预措施
Experimental Group
the intervention group will receive twice-daily an oral supplementation with a combination of L-arginine 1.66 g plus liposomal Vitamin C 500 mg for 8 weeks
干预措施: Bioarginina C (Dietary Supplement)
Control
Control group will receive placebo twice a day for 8 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
6MWT
时间窗: 2 months
Change from baseline to day 56 in the distance walked on the 6 min walk test
次要结局
- HG(2 months)
- CST(2 months)
- FMD(2 months)