None listed
Conditions
Interventions
Intervention1: Shilajit gummies: Two Shilajit gummies in sequence once daily after a major meal for 60 days.
Control Intervention1: Placebo gummies: Two Placebo gummies in sequence once daily after a
Sponsors
Mosaic Wellness Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male participants aged between 18-40 years having BMI less than 35 kg per m2;2.Resting blood pressure averaging less than 140 by 90 mmHg;3.Not on any medication for cardiovascular and metabolic disorders;4.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;5.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;6.Willing to provide consent and come for regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Participants with any acute illness requiring immediate medical care; 2.Participants with any chronic medical condition; 3.Participants with sedentary lifestyle not able or not advised to undergo the resistance training as per protocol; 4.Any clinically relevant macro or micro-nutrient deficiency as per investigator discretion; 5.Any other condition which proves participant unfit for the study participation; 6.Any known cardiovascular or metabolic disease; 7.Participants who are taking any herbal nutraceutical supplements except plant-based protein supplementation; 8.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in muscle strength using a standard plate loaded leg press and chest press machine, Rep max for leg press and chest press at screening and day 60. 2.Changes in muscle endurance using a standard plate loaded leg press and chest press machine by measuring Reps to fatigue at 50 percent 1 Rep Max at screening and day 60. 3.Changes in hypertrophy measurements of at three sites that is arm (flexed mid upper arm), chest (sternum at mid tidal volume) and upper thigh (just inferior to gluteal fold) (in cm) at screening and day 60. 4.Changes in the rating of perceived exertion at screening, day 30 and day 60. Modified to encompass the entire training day. 1 to 10 scale as to how hard that workout was. The higher the scale score, the harder the workout felt to the participant. 5. Assessment of changes in recovery from exercise Post Delayed onset muscle soreness (DOMS),48 hours at screening, day 30 and day 60.Timepoint: Screening, day 30 and day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in serum total testosterone, free testosterone levels & cortisol levels at screening & day 60. 2.Changes in muscle damage markers creatine kinase (CK), at Pre Exercise Bout, Immediate Post Exercise Bout & 24 Hours Post-Exercise Bout at screening & day 60. 3.Changes in cardiorespiratory endurance by VO2 max by harvard step test at screening, day 30, & day 60. 4.Changes in percent fat & skeletal muscle mass using BIA at screening & day 60. 5.Changes in anthropometric parameters body weight (kg), BMI (Kg per m2) at screening, Day 30 & day 60.Timepoint: Screening, day 30 & day 60 | — |
Countries
India
Contacts
Public ContactShreyans Jain
Mosaic Wellness Pvt Ltd
Outcome results
None listed