None listed
Conditions
Interventions
None listed
Sponsors
Amaara Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male participants aged between 21 to 50 years having BMI less than or equal to 30 kg per meter square. 2. Resting blood pressure averaging less than or equal to 140 or 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 a 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 investigators discretion. 5. Any other condition that proves the participant unfit for the study participation. 6. Any known cardiovascular or metabolic disease. 7. 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). 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 (kg) assessed by 1RM on the leg press. 2. Changes in muscle endurance (repetitions) assessed by reps on the leg press. 3. Changes in the rating of perceived exertion. 4. Assessment of changes in recovery from exercise Post Delayed onset muscle soreness (DOMS).Timepoint: 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
| Measure | Time frame |
|---|---|
| 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. 3. Changes in serum total & free testosterone, CRP, & at baseline & day 90. 4. Changes in muscle damage marker Creatine kinase & LDH at baseline & day 90. 5. Changes in Hand grip strength by hand dynamometer at screening & day 90. 6. Changes in the participant & investigator global assessment score at Baseline & Day 90. Timepoint: 1.screening, day 30, day 60 & on day 90. 2. screening & day 90. 3. baseline & day 90. 4. baseline & day 90. 5. screening & day 90. 6. baseline & day 90. | — |
Countries
India
Contacts
Public ContactMr Manoj Karwa
Amaara Ayurveda
Outcome results
None listed