The Effect of XSurgeTM Supplementation on Biomarkers, Oxidative Stress, and Recovery From High Intensity Resistance Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Strength as measured by Peak Torque (Biodex)
研究概览
简要总结
Part one of this study will consist of baseline (BL) testing, 28 days of daily supplementation with XSurge, and an exercise protocol. The acute exercise protocol consists of five visits, of which, the first visit will consist of maximal strength testing. The remaining visits will consist of performance testing and muscle evaluation.
Phase two of this study will consist of six weeks of supervised resistance training along with supplementation of XSurge. Following the six weeks of training, subjects will complete a second acute exercise protocol. Measures to be evaluated will consist of performance testing and muscle evaluation.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Recreationally active.
- •Subject is judged by the Investigator to be healthy and free of any physical limitations
- •Subject is male 18-35 y of age, inclusive
- •Subject has a body mass index of 18.0-34.9 kg/m2
- •Subject is willing to maintain habitual diet
- •Subject is willing to abstain from dietary supplementation
- •Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators
排除标准
- •Subject is currently or will be enrolled in another clinical trial.
- •Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
- •Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- •Subject is unable to perform physical exercise
- •Subject is a current smoker or has quit within the last 6 months
- •Subject is engaged in an extreme diet including but not limited to, Atkins, South Beach, Intermittent Fasting, etc.
- •Subject is allergic to the study product or placebo
- •Subject is taking any other nutritional supplement or performance enhancing drug
- •Subjects that have donated blood or plasma within the previous week
- •Subject has any chronic illness that causes continuous medical care
- •Taking any type of prescription or over-the-counter medication including but not limited to corticosteroids, non-steroidal anti-inflammatory drugs, and antibiotics within the 14 days prior to the screening visit.
研究组 & 干预措施
Placebo
Placebo group will receive microcrystalline cellulose
干预措施: Placebo: Microcrystalline Cellulose (Other)
Treatment
Treatment group will get 2 g daily of XSurge in microcrystalline cellulose
干预措施: XSurge (Dietary Supplement)
Control Group
The control group will be included to quantify or describe the effects of the acute exercise training but will not receive any supplement
干预措施: Control: No supplementation (Other)
结局指标
主要结局
Strength as measured by Peak Torque (Biodex)
时间窗: Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise
Biomarkers (Cortisol and Creatine Phosphokinase)
时间窗: Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise
次要结局
- Subjective Feelings of Recovery (Likert Scale)(Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise)
- Muscle Soreness (VAS)(Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise)