Effect of Silkworms (Bombyx Mori L.) Pupae Extracts on Musculoskeletal Biomarkers in Adults With With Relatively Low Muscle Mass: 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
- 54
- 试验地点
- 2
- 主要终点
- the peak torque at 60°/s knee extension (/kg)
研究概览
简要总结
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of silkworms (Bombyx mori L.) pupae 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 silkworms (Bombyx mori L.) pupae extracts may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of silkworms (Bombyx mori L.) pupae 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 12 weeks of intervention. Fifty four adults were administered either 2,400 mg of silkworms (Bombyx mori L.) pupae 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 —（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
排除标准
- •Vegetarian
- •History of any central bone fracture within 1 year
- •History of cancer or serious cerebro-cardiovascular diseases within 6 months
- •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)
- •Uncontrolled hypertension (>160/100 mmHg)
- •Uncontrolled thyroid diseases.
- •History of medication for psychiatric diseases such as severe affective disorder, schizophrenia, and substance use.
- •Alcohol abuser
- •Allergic reaction to constituent foods
- •Severe gastrointestinal symptoms such as heartburn and indigestion
- •Those who are pregnant, lactating, or planning to become pregnant during the clinical trial
- •Those who have participated in other drug clinical trials within the last 3months
结局指标
主要结局
the peak torque at 60°/s knee extension (/kg)
时间窗: 12 weeks
conducted on the Biodex System 3 Pro isokinetic dynamometer (Biodex, Inc.)
次要结局
- appendicular skeletal mass/weight x 100(12 weeks)
- concentration of creatine (mg/dL)(12 weeks)
- handgrip strength (kg), right and left(12 weeks)
- total fat percent (%)(12 weeks)
- appendicular skeletal mass/(height x height)(12 weeks)
- concentration of creatinine kinase (IU/L)(12 weeks)
- skeletal Muscle Mass Index/(height x height)(12 weeks)
- EuroQol five dimensional five levels(12 weeks)
- body weight (kg)(12 weeks)
- skeletal musle mass (kg)(12 weeks)
- truncal fat percent (%)(12 weeks)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital