Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in creatine kinase
研究概览
简要总结
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fermented Velvet Antler extract on fatigue recovery after exercise. The investigators measured fatigue recovery parameters , including lactate, ammonia, inorganic phosphorus, creatine kinase and LDH, and monitored their blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 19-60 years old
- •Hemoglobin concentration between 13 and 14 g/dL(men), 12 and 13 g/dL(women)
- •Able to give informed consent
排除标准
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •Participation in any other clinical trials within past 2 months
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •Pregnant or lactating women etc.
研究组 & 干预措施
Fermented Velvet Antler extract
干预措施: Fermented Velvet Antler extract (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in creatine kinase
时间窗: 12 weeks
Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).
Changes in inorganic phosphorus
时间窗: 12 weeks
Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week).
Changes in ammonia
时间窗: 12 weeks
Ammonia was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Lactage dehydrogenase(LDH)
时间窗: 12 weeks
Lactage dehydrogenase(LDH) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in lactate
时间窗: 12 weeks
Lactate was measured in study visit 1(0 week) and visit 3(12 week).
次要结局
- Changes in Multidimensional Fatigue Scale(MFS)(12 weeks)
- Changes in 36-Item Short-Form Health Survey(SF-36)(12 weeks)
研究者
Soo-Wan Chae
Clinical Trial Center for Functional Foods
Chonbuk National University Hospital