Effect of Aureobasidium Pullulans Produced β-glucan and Regular Combined Exercise on Musculoskeletal Function and Biomarkers in Adults With Relative Sarcopenia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- TUG test
研究概览
简要总结
The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Aureobasidium pullulans produced β-glucan and regular combined exercise on muscle strength, muscle mass, muscle function, and biomarkers in adults with relative sarcopenia for 12 weeks.
详细描述
A previous human study has indicated that Aureobasidium pullulans produced β-glucan may increase muscle mass and strength in the elderly. Therefore, the investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Aureobasidium pullulans produced β-glucan on muscle strength, muscle mass, and muscle function, expanding the target population to adults aged 50 and older 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 and 12 weeks of intervention. Eighty adults were administered either 1,000 mg of Aureobasidium pullulans produced β-glucan 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
- Supportive Care
- 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
- •Grip strength of the frequently used hand is based on the following age-specific standards: Men in their 50s (less than 42 kg, women: less than 25.1 kg), Men in their 60s (less than 38.5 kg, women: less than 24.1 kg), Men 70 and older (less than 33.2 kg, women: less than 20.9 kg)
- •Individuals with a Short Physical Performance Battery score of 9 or higher.
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, and drug intoxication.
- •Alcohol abuser
- •Allergic reaction to Aureobasidium pullulans produced β-glucan
- •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
研究组 & 干预措施
Placebo group
This group takes placebo for 12 weeks.
干预措施: Placebo (Dietary Supplement)
Aureobasidium pullulans produced β-glucan group
This group takes Aureobasidium pullulans produced β-glucan for 12 weeks.
干预措施: Aureobasidium pullulans produced β-glucan (Dietary Supplement)
结局指标
主要结局
TUG test
时间窗: 12 weeks
Timed Up \& Go test
Muscle strength, 60°/s peak torque (%bodyweight)
时间窗: 12 weeks
60°/s knee extension peak torque (PT) normalized to bodyweight (BW) (PT/BW), right, left, average and 60°/s knee flextion peak torque normalized to body weight (PT/BW), right, left, average
次要结局
- Repeated chair stand test (seconds)(12 weeks)
- EuroQol five dimensional five levels(12 weeks)
- Concentration of insulin-like growth factor 1(12 weeks)
- 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)
- Hand grip strength, both(12 weeks)
- Total body fat (%)(12 weeks)
- Truncal body fat (%)(12 weeks)
- Muscle power(12 weeks)
- Skeletal muscle mass (kg)(12 weeks)
- Short Physical Performance Battery total score(12 weeks)
- Gait speed (seconds)(12 weeks)
- Muscle strength, 60°/s peak torque(12 weeks)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital