A Prospective, Randomized, Double-Blind, Placebo-Controlled, Cross Over Study to Evaluate the Safety and Efficacy of Capsimax on Exercise Performance.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean change in efficacy parameters of Peak power and rate of force development during an isometric strength test,performance during the barbell back squat exercise protocol and performance during the push-up protocol.
研究概览
简要总结
This is a prospective, double blind, randomized, placebo-controlled, cross-overstudy. The subjects will be explained about the study procedures, the risks and discomforts, the investigational product (IP) and other alternative supplements. Informed consent will be obtained from subjects who are willing to participate in the study. After the informed consent process, demographic details will be obtained. The subjects’ anthropometric data will be obtained The subjects who fulfil the study inclusion criteria and who do not meet any exclusion criteria will be eligible for the study. The subjects shall be randomly (double blind) assigned in 1:1 ratio to one of the treatment groups. A wash-out period of 7 ± 1 day will be followed for cross-over of treatments.Statistical comparisons for efficacy shall be made between test product and placebo.The total study duration for the clinical part shall be a maximum of 24 days which includes 3 days of screening period, 14 days of treatment period and 7 days of washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Male
入选标准
- •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 familiar with 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.Subjects willing to refrain from vigorous physical activity/ strenuous exercise 24 hours prior to test days.Subjects willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •Subjects having hypersensitivity or history of allergy to the study product.Subjects with uncontrolled hypertension (SBP greather than 160 mmHg or DBP greater than 100 mmHg) at screening.Subjects with a malignant disease or any concomitant end-state organ disease and or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition)and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.Subjects with inability to swallow soft gel capsules.Subjects who require medications.Subjects who regularly use a dietary supplement containing Capsimax or other ingredients that would impact study endpoints.Subjects with a history of drug and or alcohol abuse at the time of enrolment.Subjects who have 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
Mean change in efficacy parameters of Peak power and rate of force development during an isometric strength test,performance during the barbell back squat exercise protocol and performance during the push-up protocol.
时间窗: Baseline, Day 7, Day 15 and Day 21
次要结局
- Mean change in Velocity related measure and Resting energy expenditure.
- Mean change in Nitric oxide bioavailability and skeletal muscle oxygenation
- Mean change in Agility and reaction time
- Mean change in VAS for feelings of fatigue and pain and Rating of perceived exertion(Baseline, Day 7, Day 15 and Day 21)
- Mean change in Glucagon-like peptide-1(Baseline, Day 7 and Day 21)
- Overall safety(Baseline, Day 7, Day 15 and Day 21)
研究者
Dr Arun Kumar Rawal
Prehab Musculoskeletal and Sports Health Clinics