A randomized, double-blind, multicenter, placebo-controlled clinical study of TruBlk™ Shilajit Resin to evaluate the efficacy focusing on their impact in improving exercise performance, endurance, muscle strength, and recovery in males.
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Amaara Ayurveda
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- 1. Changes in muscle strength (kg) assessed by 1RM on the leg press.
Overview
Brief Summary
This is a randomized, double blind, multicenter, placebo controlled clinical study designed to evaluate the efficacy and safety of TruBlk™ Shilajit Resin in improving exercise performance, endurance, muscle strength, and recovery in healthy adult males over a 90 day period. A total of 100 male participants aged 21 to 50 years, engaged in regular resistance training, will be randomized in a equal ratio to receive either 250 mg of TruBlk™ Shilajit Resin twice daily or placebo for 90 days. The primary objective is to assess improvements in muscle strength, endurance, perceived exertion, and post exercise recovery. Secondary objectives include evaluating changes in cardiorespiratory endurance (VO2 max), testosterone levels, inflammatory marker (CRP), muscle damage markers (CK and LDH), body composition, and hand grip strength. Safety will be monitored through adverse event reporting, vital signs, and treatment compliance. The study includes 4 visits, baseline, day 30, day 60, and day 90.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 21.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Male participants aged between 21 to 50 years having BMI less than or equal to 30 kg per meter square.
- •Resting blood pressure averaging less than or equal to 140 or 90 mmHg.
- •Not on any medication for cardiovascular and metabolic disorders.
- •Engaged in regular resistance training (comprising of cardio and strength training) for at least 1 year and willing to continue the same during the study.
- •Participants consuming whey protein and possess a sufficient level of knowledge regarding the importance of dietary and lifestyle factors relevant to the study, as determined by the investigator.
Exclusion Criteria
- •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.
- •Any known cardiovascular or metabolic disease.
- •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.
Outcomes
Primary Outcomes
1. Changes in muscle strength (kg) assessed by 1RM on the leg press.
Time Frame: 1. screening, day 30, day 60, and on day 90. | 2. screening, day 30, day 60, and on day 90. | 3. screening, day 30, day 60, and on day 90. | 4. screening, day 30, day 60, and on day 90.
2. Changes in muscle endurance (repetitions) assessed by reps on the leg press.
Time Frame: 1. screening, day 30, day 60, and on day 90. | 2. screening, day 30, day 60, and on day 90. | 3. screening, day 30, day 60, and on day 90. | 4. screening, day 30, day 60, and on day 90.
3. Changes in the rating of perceived exertion.
Time Frame: 1. screening, day 30, day 60, and on day 90. | 2. screening, day 30, day 60, and on day 90. | 3. screening, day 30, day 60, and on day 90. | 4. screening, day 30, day 60, and on day 90.
4. Assessment of changes in recovery from exercise Post Delayed onset muscle soreness (DOMS).
Time Frame: 1. screening, day 30, day 60, and on day 90. | 2. screening, day 30, day 60, and on day 90. | 3. screening, day 30, day 60, and on day 90. | 4. screening, day 30, day 60, and on day 90.
Secondary Outcomes
- 1. Changes in cardiorespiratory endurance by VO2 max test by Harvard step test at screening, day 30, day 60 & on day 90.(2. Changes in percentage fat & skeletal muscle mass using BIA at screening & day 90.)
Investigators
Dr Sanjay Mishra
Bensups Hospital