Impact of 12-Week Creatine HCl Supplementation on Body Composition, Functional Muscle and Brain Performance, Blood Biomarkers, and Tissue Creatine Levels in Older Adults With Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Hand-grip strength
研究概览
简要总结
The CONCRET-SARCOPA trial is a 12-week, double-blind, randomized controlled study designed to evaluate the efficacy of creatine HCl supplementation in older adults with sarcopenia. The trial investigates whether daily creatine HCl improves body composition, enhances functional muscle and cognitive performance, and favorably alters key blood biomarkers associated with muscle health and metabolic status. Additionally, the study assesses changes in tissue creatine levels using non-invasive and biochemical methods to clarify mechanistic responses to supplementation. Findings from this trial will provide critical evidence on the therapeutic potential of creatine HCl as a targeted nutritional strategy for managing sarcopenia in the geriatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 60 years
- •Low muscle strength by handgrip (SDOC criteria for sarcopenia): < 35.5 kg in men and < 20 kg in women
- •Sign free and informed consent
- •Demonstrate interest, conditions and availability to participate
排除标准
- •Patients undergoing interventional treatment for sarcopenia
- •Physical amputation
- •Cognitive impairment (MSSE < 25)
- •Unwillingness to return for follow-up analysis
- •Participation in other clinical trials
结局指标
主要结局
Hand-grip strength
时间窗: Change from baseline hand-grip strength at 12 weeks
Handgrip strength quantifies maximal voluntary force generated by the hand using a dynamometer, serving as a simple, reliable indicator of overall muscle function and sarcopenia severity.
次要结局
- Senior fitness test score(Change from baseline senior fitness test score at 12 weeks)
- Mini-Mental State Examination Score(Change from baseline Mini-Mental State Examination Score at 12 weeks)
- Appendicular muscle mass(Change from baseline appendicular muscle mass at 12 weeks)
- Irisin(Change from baseline serum levels of irisin at 12 weeks)
- Brain creatine(Change from baseline brain creatine concentrations at 12 weeks)