Effect of Ishige Okamurae Extract on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia: 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
- 2
- 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 Ishige Okamurae extracts on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia for 12 weeks.
详细描述
A previous study has indicated that Ishige Okamurae extracts may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Ishige Okamurae extracts on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia; the safety of the compound are also evaluated. 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 300 mg of Ishige Okamurae extracts 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
- 50 Years 至 85 Years（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 (more than twice the normal upper limit of the research institute)
- •Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar)
- •History of fracture during the previous year
- •Uncontrolled hypertension (>160/100 mmHg)
- •Uncontrolled thyroid diseases.
- •History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months
- •History of any central bone fracture within 1 year
- •History of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication.
- •Alcohol abuser
- •Allergic reaction to Ishige Okamurae
- •Those who participated in other drug clinical trials within 1 month from the screening date.
- •Severe gastrointestinal symptoms such as heartburn and indigestion
- •Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
- •Those who are judged to be unsuitable by the PI for other reasons
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
- skeletal Muscle Mass Index/(height x height)(12 weeks)
- appendicular skeletal mass/(height x height)(12 weeks)
- appendicular skeletal mass/weight x 100(12 weeks)
- EuroQol five dimensional three levels(12 weeks)
- concentration of creatinine kinase (IU/L)(12 weeks)
- concentration of lactate (mg/dL)(12 weeks)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital