A Post-marketing, Double-blind, Placebo-controlled, Randomized, Parallel Study to Evaluate the Effect of Dietary Supplement on Muscle Mass and Physical Performance Among People Aged 50 Years and Older
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in 30-sec chair stand test (unit: number of stand) at 12 weeks after baseline
研究概览
简要总结
To assess the ability and safety profile of dietary supplement to augment lean body mass, muscle strength, and physical performance among people aged 50 years and older
详细描述
In light of the rapidly expanding aging population, sarcopenia and related disorders are emerging as a major public health problem of the 21st century.Sponsor has produced a dietary supplement, which has been on market in Taiwan. The proposed study is conducted to confirm whether the amino acid supplementation is able to enhance the magnitude of gain in lean body mass and muscle strength in middle-aged and older adults with muscle loss or sarcopenia undergoing exercise training.
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)
盲法说明
double blind
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 50 years or older.
- •Subjects who has muscle loss or at risk of muscle loss, with symptoms of reduced physical activities, reduced gait speed, exhaustion, or had tumbled/ fallen within past year
- •Willing to comply with study procedures and follow-ups
- •Provide written consent
排除标准
- •Gait speed ≤ 0.3 m/sec
- •Any disease that interferes with limb function, including:
- •Limb fracture within past 6 months
- •Severe knee, hip, or arm arthritis
- •As judged by the investigator, disorder of nervous system (i.e., stroke, severe spinal stenosis, peripheral neuropathy, and Parkinson's disease) with poor control
- •Intermittent claudication due to peripheral artery disease
- •As judged by the investigator, mental disorders (i.e., confirmed diagnosis of dementia) with poor control
- •Cardiopulmonary disease with poor control judged by the investigator
- •Malignancy with poor control judged by the investigator
- •Subjects claim to have chronic renal disease, defined as kidney damage or GFR < 30 mL/min/1.73 m2 for at least 3 months
- •Severe visual and hearing impairment that becomes barrier to communication
- •Subjects have taken any hormone replacement therapy within 3 months prior to study enrollment, or plans to begin hormone replacement therapy at any time during the study
- •Subjects with known poorly controlled diabetes (HbA1c > 9.0%), hyperthyroidism or thyroid insufficiency, Cushing's syndrome, or adrenal insufficiency
- •Subjects with known milk allergy or lactose intolerance
- •Other conditions that investigator considers subject is ineligible to participate in the study
结局指标
主要结局
The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in 30-sec chair stand test (unit: number of stand) at 12 weeks after baseline
时间窗: 12 weeks
The score is the total number of stands within 30 seconds.
The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in bone-free lean body mass (unit: kilogram) at 12 weeks after baseline
时间窗: 12 weeks
Bone-free lean body mass will be assessed by measured by dual- energy X-ray absorptiometry. An increment of ≥ 3% from baseline after 12 weeks of intervention will be regarded as clinically meaningful improvement.
The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in strength of hand grip (unit: kilogram) at 12 weeks after baseline
时间窗: 12 weeks
Strength of hand grip will be assessed by Smedlay's DynamoMeter TTM Tokyo Japan. An increment of ≥ 3% from baseline after 12 weeks of intervention will be regarded as clinically meaningful improvement.
次要结局
- Mean change in short physical performance battery (SPPB) score at 4 and 12 weeks after baseline(12 weeks)
- Mean change in bone-free lean body mass at 4 and 12 weeks after baseline(12 weeks)
- Adverse events(12 weeks)
- Mean change in strength of hand grip at 4 and 12 weeks after baseline(12 weeks)
- Mean change in 30-sec chair stand test at 4 and 12 weeks after baseline(12 weeks)
- Mean change in 6-meter walk test at 4 and 12 weeks after baseline(12 weeks)
- Mean change in intramuscular fat assessed by MRI at 12 weeks after baseline(12 weeks)