An interventional study of Resistance Training + Placebo (Capsule) + Placebo (Sachet) and Resistance Training + Whey protein (40 gms) + Placebo (Capsule) in Skeletal Muscle Strength & Growth, sponsored by Vedic Lifesciences Pvt. Ltd.. Recruiting at 3 sites in India. Open to male participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Other
The present study is a randomized, placebo-controlled, double blinded study to evaluate efficacy of EB-PA as protein amplifier for skeletal muscle strength \& growth in males with active lifestyle. Approximately 160 subjects aged between ≥ 20 and ≤ 35 years will be screened and 138 participants are to be randomized. Both the IP and placebo study arms will have at least 40 completed subjects after accounting for the screening failure and dropout/withdrawal rate of 14% and 13 % respectively (Total 120 completers). The treatment duration for all the study subjects will be 30 days. The sustained effect of the product will be observed for next 7 days, wherein, the subjects will be abstaining from the protein and IP supplementation and will exercise at their ease.
Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
A sachet of 20 gms of Placebo dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of placebo to be taken 30 minutes after placebo sachet in the morning.
Dietary Supplement: Resistance Training + Placebo (Capsule) + Placebo (Sachet)
A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of Placebo to be taken 30 minutes after whey protein in the morning.
Dietary Supplement: Resistance Training + Whey protein (40 gms) + Placebo (Capsule)
A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of EB0-PA to be taken 30 minutes after whey protein in the morning.
Dietary Supplement: Resistance Training + Whey protein (40 gms) + EB-PA (500 mg)
* Placebo sachet of 20 gms dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. * One Placebo capsule to be taken 30 minutes after sachet in the morning.
A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. - One Placebo capsule to be taken 30 minutes after whey protein in the morning
* A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. * One capsule of EB-PA to be taken 30 minutes after whey protein in the morning
To assess improvement in muscle strength after administration of Investigational Product (IP) as assessed by increase in lower body 1 RM (repetition maximum) weight from baseline.
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ \[1.0278 - (0.0278 × Number of repetitions)\].
Time frame: Day 30
To assess improvement in muscle strength after administration of Investigational Product (IP) as assessed by increase in upper body 1 RM (repetition maximum) weight from baseline.
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ \[1.0278 - (0.0278 × Number of repetitions)\].
Time frame: Day 30
To assess the effect of Investigational Product (IP) on Increase in muscle endurance as assessed by increase in exercise volume calculated as load x number of repetition (upper + lower body exercise) completed at ≥70% of screening 1-RM.
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ \[1.0278 - (0.0278 × Number of repetitions)\].
Time frame: Day 0 to Day 30
To assess the effect of Investigational Product (IP) on Increase in muscle (hamstring) flexibility as assessed by increase in distance for V sit & reach test.
V sit and reach test is performed to measure the flexibility of the lower back and back thigh muscles.
Time frame: Day 0 to Day 30
To assess the effect of IP on improvement in muscle mass as indicated by increase in fat free mass (FFM), lean muscle mass and android fat by DXA.
Total body scans will be performed using a device with its scan mode already determined automatically by the device operating system within the manufacture specification.
Time frame: Day 0 to Day 30
To assess the effect of IP on improvement in grip strength as indicated by increase in non-dominant hand grip strength.
Each subject will perform the test three times approximately with 25±5 sec relaxations between the session. The participant should be instructed to squeeze the dynamometer until the grip is stable. For 3 sets, the reading will be noted in Kg and an average of 3 readings will be calculated.
Time frame: Day 0 to Day 30
To assess the effect of IP on Improvement in metabolic health as indicated by waist to height ratio.
Waist circumference (WC) will be measured at the end of a normal expiration using a non-stretchable measuring tape.
Time frame: Day 0 to Day 30
To assess the sustained effect of IP on muscle strength as assessed by Maintenance of lower body 1 RM weight
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ \[1.0278 - (0.0278 × Number of repetitions)\].
Time frame: Day 30 To 37
To assess the sustained effect of IP on muscle strength as assessed by Maintenance of upper body 1RM weight
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ \[1.0278 - (0.0278 × Number of repetitions)\].
Time frame: Day 30 To 37
Plan to share: Undecided
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Vedic Lifesciences Pvt. Ltd.