An Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Shilajit Resin on Endurance, Muscle Performance, and Body Composition in Healthy Adults
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 1. Changes in muscle strength (kg) assessed by 1RM on the leg press at baseline, Day 14 and Day 28.
研究概览
简要总结
This is an open label single arm interventional pilot study designed to evaluate the efficacy and safety of TruBlk™ Shilajit Resin 250 mg twice daily in improving muscle endurance strength fatigue and body composition in healthy physically active adult males aged 21 to 55 years A total of 25 participants will receive the investigational product over a 28 day period Primary endpoints include changes from baseline in 1RM leg press strength endurance repetitions perceived exertion Delayed Onset Muscle Soreness recovery fatigue severity and isometric handgrip strength Secondary assessments include changes in body composition VO2 max and serum biomarkers Testosterone CK LDH CRP Safety will be monitored through adverse events vitals and laboratory parameters.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male participants aged between 21 to 55 years having BMI less than or equal to 30 kg per meter square.
- •Engaged in regular resistance training (comprising of cardio and strength training) and willing to continue the same during the study.
- •Not on any medication for cardiovascular and metabolic disorders.
- •Willing to maintain their routine diet and physical activity levels throughout the study.
- •Willing and able to provide written informed consent and comply with study procedures.
排除标准
- •Participants with any acute illness requiring immediate medical care.
- •Participants with any chronic medical condition.
- •Participants with a sedentary lifestyle not able or not advised to undergo the resistance training as per protocol.
- •Any clinically relevant macro or micro nutrient deficiency as per investigators discretion.
- •Any other condition that proves the participant unfit for the study participation.
- •Participants who are currently taking any herbal supplements, nutraceuticals, creatinine, anabolic steroids, testosterone boosters, or non prescribed medications that may impact muscle growth, endurance, or testosterone levels (with the exception of protein supplements).
- •Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of the study.
结局指标
主要结局
1. Changes in muscle strength (kg) assessed by 1RM on the leg press at baseline, Day 14 and Day 28.
时间窗: 1. Baseline, Day 14 and Day 28 | 2. Baseline, Day 14 and Day 28 | 3. Baseline, Day 14 and Day 28 | 4. Baseline, Day 14 and Day 28 | 5. Baseline, Day 14 and Day 28 | 6. Baseline and Day 28
2. Changes in muscle endurance assessed by reps on the leg press after 1RM at baseline, Day 14 and Day 28.
时间窗: 1. Baseline, Day 14 and Day 28 | 2. Baseline, Day 14 and Day 28 | 3. Baseline, Day 14 and Day 28 | 4. Baseline, Day 14 and Day 28 | 5. Baseline, Day 14 and Day 28 | 6. Baseline and Day 28
3. Changes in the rating of perceived exertion at baseline, Day 14 and Day 28.
时间窗: 1. Baseline, Day 14 and Day 28 | 2. Baseline, Day 14 and Day 28 | 3. Baseline, Day 14 and Day 28 | 4. Baseline, Day 14 and Day 28 | 5. Baseline, Day 14 and Day 28 | 6. Baseline and Day 28
4. Changes in recovery from exercise Post Delayed onset muscle soreness (DOMS), (defined as aching pain and soreness in a given muscle post 48 hours of exercise) at baseline, Day 14 and Day 28.
时间窗: 1. Baseline, Day 14 and Day 28 | 2. Baseline, Day 14 and Day 28 | 3. Baseline, Day 14 and Day 28 | 4. Baseline, Day 14 and Day 28 | 5. Baseline, Day 14 and Day 28 | 6. Baseline and Day 28
5. Change in Fatigue levels assessed using Fatigue Severity Scale (FSS) at baseline, Day 14 and Day 28.
时间窗: 1. Baseline, Day 14 and Day 28 | 2. Baseline, Day 14 and Day 28 | 3. Baseline, Day 14 and Day 28 | 4. Baseline, Day 14 and Day 28 | 5. Baseline, Day 14 and Day 28 | 6. Baseline and Day 28
6.Change in isometric muscle strength (dominant and non-dominant hand) using a hand dynamometer at baseline and Day 28.
时间窗: 1. Baseline, Day 14 and Day 28 | 2. Baseline, Day 14 and Day 28 | 3. Baseline, Day 14 and Day 28 | 4. Baseline, Day 14 and Day 28 | 5. Baseline, Day 14 and Day 28 | 6. Baseline and Day 28
次要结局
- 1. Change in body composition (lean body mass, fat mass) as measured by Body Composition Analyser (BCA) at baseline and Day 28.(2. Changes in cardiorespiratory endurance by VO2 max test by using modified Harvard step test at baseline and day 28.)
研究者
Dr Sanjay Mishra
Bensups Hospital