The present study is a placebo- controlled, single-blind sequential study. Total of 40 males aged between ≥ 18 years and ≤35 years will be screened. Assuming screen failure and dropout rate in this study, a minimum of 30 participants should complete the study. The treatment duration for all the study participants will be 60 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
36
Dr. Kumta Solanki's Clinic
Mumbai, Maharashtra, India
NOT_YET_RECRUITINGDr. Preeti Bawaskar's Clinic
Thane, Maharashtra, India
RECRUITINGTo assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion)
Time frame: Day 31
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion)
Time frame: Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Increase in the lower-body strength (Peak anaerobic power output (PAPw)) as assessed by a vertical jump test
Time frame: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Improvement in upper body strength as assessed by medicine ball throw test
Time frame: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
The flexibility of the hamstrings as assessed using the V sit-and-reach test
Time frame: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Improvement in muscle mass as indicated by an increase in fat-free mass (FFM) by DXA
Time frame: Day 0, Day 31 and Day 61
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To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Decrease in central obesity as indicated by a decrease in android fat percentage by DXA.
Time frame: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Improvement in metabolic health as indicated by the waist-to-height ratio (WHtR)
Time frame: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Improves muscle protein synthesis as assessed by an increase in serum insulin at 0, 1 \& 3 hours post IP administration.
Time frame: Day 0, Day 31 and Day 61