A Randomized, Double Blinded, Crossover designed, Placebo Controlled Study to evaluate the effects of supplement REPHYLL on delayed onset muscle soreness (DOMS) in humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in isometric strength Change in flexibility Change in blood parameters
研究概览
简要总结
Delayed-onset muscle soreness (DOMS) describes muscle pain and tendernessthat typically develop several hours post exercise and consist of predominantlyeccentric muscle actions, especially if the exercise is unfamiliar. Eccentricexercise continues to receive attention as a productive means of exercise.Coupled with this has been the heightened study of the damage that occurs inearly stages of exposure to eccentric exercise. This is commonly referred to asdelayed onset muscle soreness (DOMS). Muscle pain and tendernessgenerally develop 24 hours after such exercise and are usually described asdelayed-onset muscle soreness (DOMS).
DOMS remains uncertain,it is generally accepted that DOMS is caused by inflammation of the damagedmuscle and/or connective tissue and the efflux of substances from the damagedtissue to the extracellular space that sensitize the free nerve endings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 29.00 Year(s)（—）
- 性别
- Male
入选标准
- •Subject has provided written and dated informed consent to participate in the study.
- •Subject is willing and able to comply with the protocol.
- •Subject is a male between 19 and 29 years of age, inclusive.
- •Subject is in good health as determined by a health history questionnaire.
- •Subject is untrained in resistance/power exercise.
排除标准
- •Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment.
- •Subject has a history of alcohol or other drug abuse in the past year.
- •Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) [systolic BP> 140 and/or diastolic BP> 90], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
- •Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study.
- •Subject has a known allergy or sensitivity to any ingredient in the test product.
- •Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
- •Subject has used creatine within 9 weeks prior to screening.
- •Subject has a history of orthopedic injury or surgery within the last year.
- •Subject has any physical condition considered a contra-indication to the type of exercise performed in the study.
- •Subject has had an abnormal resting ECG.
- •Investigator is uncertain about subject’s capability or willingness to comply with the protocol requirements.
结局指标
主要结局
Change in isometric strength Change in flexibility Change in blood parameters
时间窗: day1 day21
次要结局
- Adverse event reports(day1 day21)