Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults: a Randomized, Double-blinded, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- muscle strength
研究概览
简要总结
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Nelutri™on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks.
详细描述
A previous study has indicated that Nelutri™ may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Nelutri™on muscle strength, muscle mass, and muscle function in healthy adults; the safety of the compound are also evaluate. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty adults were administered either 2,000 mg of Nelutri™ or a placebo each day for 12 weeks;
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •<110% of the standard lean body mass as measured using the body composition analyzer
- •Body-mass index (BMI) ranging from 18.5 to 30.0 kg/m2
- •Those who have an average protein intake of 60 g or more/day.
排除标准
- •Abnormal liver or renal function (i.e., serum aminotransferase activity > 60 IU/L and serum creatinine concentrations > 1.2 mg/dL)
- •Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
- •History of fracture during the previous year
- •Uncontrolled hypertension
- •History of serious cardiac disease such as angina or myocardial infarction
- •History of gastrectomy
- •History of medication for psychiatric disease
- •Administration of oriental medicine including herbs within the past 4 weeks
- •Evidence of relatively high skeletal mass (more than 110% of the standard lean body mass as measured using the body composition analyzer
研究组 & 干预措施
Nelutri™ group
This group takes Nelutri™ for 12 weeks
干预措施: Nelutri™ (Dietary Supplement)
Placebo group
This group takes placebo for 12 weeks
干预措施: Placebo group (Dietary Supplement)
结局指标
主要结局
muscle strength
时间窗: 12 weeks
the peak torque at 60°/s knee extension (/kg)
次要结局
- appendicular skeletal mass/(height x height)(12 weeks)
- appendicular skeletal mass/weight x 100(12 weeks)
- Skeletal Muscle Mass Index/(height x height)(12 weeks)
- Creatinine Kinase(12 weeks)
- Lactate(12 weeks)
- EuroQol five dimensional three levels (EQ-5D-3L)(12 weeks)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital