Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- IGF-1 Levels
研究概览
简要总结
The goal of this Clinical Trial is to analyze effect of Ophiochepalus striatus extract on serum IGF-1 and IL-6 levels in elderly patients with sarcopenia. The main questions it aims to answer are:
- Can giving Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase IGF-1 levels in elderly people with sarcopenia?
- Can administration of 2x5 grams dose of Ophiocephalus striatus extract for 2 weeks reduce IL-6 levels in elderly with sarcopenia?
- Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks reduce the SARC-F score in elderly people with sarcopenia?
- Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle mass in elderly people with sarcopenia?
- Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle strength in elderly people with sarcopenia?
- Can administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks improve physical performance in elderly with sarcopenia?
Participants will:
- Consume Ophiochepalus striatus extract 2x5 grams a day.
- Checked blood before and after the intervention.
- Measured muscle mass, muscle strength, and physical performance before and after the intervention.
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
- Double (Participant, Investigator)
盲法说明
Both participant and investigator dont know the intervention that have been given.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients with sarcopenia diagnosed using AWGS criteria consist of low muscle mass: using the BIA examination tool where men: <7.0kg/m2, women: <5.7kg/m2 plus low muscle strength using a handgrip dynamometer, men: <28kg , female : <18kg or low physical performance using the 6 meter walk test; <1 meter/second.
排除标准
- •Chronic liver disease (cirrhosis of the liver) or severe liver dysfunction or increased SGPT> 3 times the upper limit of normal value
- •Impaired kidney function with a glomerular filtration rate <30 ml/minute without hemodialysis
- •Acute phase of illness (eg infection, acute arthritis, acute stroke, trauma)
- •Malignancy
- •Depression according to the geriatric depression scale (Geriatric Depression Scale score> 10)
- •History of hypersensitivity to Ophiocephalus striatus
- •Refuse to participate in research
研究组 & 干预措施
Ophiochepalus striatus extract
Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days
干预措施: Ophiochepalus striatus extract (Drug)
Placebo
Control group get placebo 2x5 grams a day for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
IGF-1 Levels
时间窗: 2 weeks
IGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3.
IL-6 Levels
时间窗: 2 weeks
IL-6 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 41148D2B69.
次要结局
未报告次要终点
研究者
Nur Riviati
Head of Geriatric Division RSUP Dr. Mohammad Hoesin Palembang, Principal Investigator
Universitas Sriwijaya