Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from Baseline of grip strength at 12 weeks
研究概览
简要总结
The loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. Sarcopenia has a prevalence of 11.6% among the elderly population in China and is closely associated with increased risks of falls, disability, and mortality. Currently, there is a lack of definition criteria for sarcopenia based on biomarkers. The Gut-Muscle Axis hypothesis suggests a complex interplay between gut microbiota and skeletal muscle. Nutritional intervention targeting the gut microbiota potentially plays a significant role in muscle regeneration. Therefore, this study aims to explore the effects of symbiotic and whey protein on muscle, gut microbiota, and clinical outcomes among sarcopenia patients, to provide a reference for further diagnosis and treatment of sarcopenia.
详细描述
This study will last 12 weeks. For the duration of the study, an anticipated total of 120 participants will be randomly assigned to three groups. During the study visits, questionnaires, blood and stool collection, and functional testing will occur. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 and older
- •Can cooperate with the measurement and questionnaire survey
- •Meets Asian Working Group for Sarcopenia (AWGS) 2019 diagnostic criteria for sarcopenia
- •Obtain informed consent to participate in this study
排除标准
- •Severe complications
- •Suffers from neuromuscular related diseases
- •Have taken antibiotics, probiotics and other medications that may affect the gut microbiota in the last 6 weeks
- •Implants of electronic devices or metal objects in the body
研究组 & 干预措施
symbiotic and whey protein intervention
This group received dietary guidance, symbiotic and whey protein intervention for 12 weeks
干预措施: symbiotic (Dietary Supplement)
whey protein intervention
This group received dietary guidance and whey protein intervention for 12 weeks
干预措施: symbiotic placebo (Dietary Supplement)
control
This group received dietary guidance and maltodextrin for 12 weeks
干预措施: symbiotic placebo (Dietary Supplement)
control
This group received dietary guidance and maltodextrin for 12 weeks
干预措施: whey protein placebo (Dietary Supplement)
whey protein intervention
This group received dietary guidance and whey protein intervention for 12 weeks
干预措施: whey protein (Dietary Supplement)
symbiotic and whey protein intervention
This group received dietary guidance, symbiotic and whey protein intervention for 12 weeks
干预措施: whey protein (Dietary Supplement)
结局指标
主要结局
Change from Baseline of grip strength at 12 weeks
时间窗: 12 weeks
Defined as muscle strength (Unit: kg)
Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks
时间窗: 12 weeks
Defined as muscle mass (Unit: kg/m2)
次要结局
- Change from Baseline of Short Physical Performance Battery score at 12 weeks(12 weeks)
- Change from Baseline of gait speed at 12 weeks(12 weeks)
- Change from Baseline of microbiota-derived metabolites at 12 weeks(12 weeks)
- Change from Baseline of inflammation status at 12 weeks(12 weeks)
- Change from Baseline of gut microbiota composition at 12 weeks(12 weeks)
研究者
Yu Kang, MD
Professor
Peking Union Medical College Hospital