A Prospective, Randomized Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate Acute Effect of Capsimax on Resistance Exercise Performance, Muscle Oxygenation, Nitric Oxide Release, Resting Energy Expenditure and Reaction Time
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Resistance exercise performance
研究概览
简要总结
Capsimax is a novel, proprietary encapsulated form of capsaicin, a natural and bioactive phytochemical found in chili pepper and other spicy food. The purpose of this study is to investigate the effect of Capsimax on resistance exercise performance, reaction time, and resting energy expenditure around exercise. This investigation will also measure muscle oxygenation and intramuscular nitric oxide in real time during resistance exercise using a non-invasive wearable technology.
Primary Objective • To examine the effects of Capsimax on physical performance metrics including peak power and rate of force development during an isometric strength test and performance during the barbell back squat exercise protocol (e.g., repetitions performed, total volume, peak power, average power).
Secondary Objectives
- To examine the effects of Capsimax on resting energy expenditure around exercise.
- To examine the effects of Capsimax on nitric oxide bioavailability and skeletal muscle oxygenation during exercise.
Exploratory Objective
• To examine the effects of Capsimax on reaction time around exercise
详细描述
Capsimax is a novel, proprietary encapsulated form of capsaicin, a natural and bioactive phytochemical found in chili pepper and other spicy food. The purpose of this study is to investigate the effect of Capsimax on resistance exercise performance, reaction time, and resting energy expenditure around exercise. This investigation will also measure muscle oxygenation and intramuscular nitric oxide in real time during resistance exercise using a non-invasive wearable technology.
Primary Objective • To examine the effects of Capsimax on physical performance metrics including peak power and rate of force development during an isometric strength test and performance during the barbell back squat exercise protocol (e.g., repetitions performed, total volume, peak power, average power).
Secondary Objectives
- To examine the effects of Capsimax on resting energy expenditure around exercise.
- To examine the effects of Capsimax on nitric oxide bioavailability and skeletal muscle oxygenation during exercise.
Exploratory Objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 否
入选标准
- •Male subjects aged between 18-35 years (both limits inclusive).
- •Subjects must have a BMI of 18.5 to 29.9 kg/m2 (both limits inclusive)
- •Subjects must have greater than one year of resistance training experience at a frequency of 2 days per week.
- •Subjects must be proficient in the barbell back squat exercise.
- •Subjects must be free of any physical limitations or chronic illness that may affect performance.
- •Subjects must be free of any medications.
- •Subjects who agree to refrain from consuming alcohol 24 hours prior to the visit days.
- •Subjects who agreed to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days
- •Subject willing to provide written consent.
排除标准
- •Subjects who have hypersensitivity or history of allergy to the study product.
- •Subjects with inability to swallow soft gel capsules.
- •Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
- •Subjects who require medications.
- •Subjects who regularly use a dietary supplement containing Capsimax or other ingredients that would impact study endpoints.
- •Subjects who had been treated with any investigational drug or investigational device within a period of 3 months prior to study entry
结局指标
主要结局
Resistance exercise performance
时间窗: 1 day
Performance during the barbell back squat exercise protocol (e.g., repetitions performed, total volume, peak power, average power).
Isometric strength test
时间窗: 1 day
Physical performance metrics will be assessed during an isometric mid-thigh pull test including peak power and rate of force development
次要结局
- Energy expenditure(1 day)
- Nitric oxide release and skeletal muscle oxygenation(1 day)
- Subjective feelings of pain and rating of perceived exertion(1 day)
研究者
Adam Gonzalez
Associate Professor
Hofstra University