Trials / Unknown
UnknownNCT06127849
A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth
A Randomized, Placebo-controlled, Blinded Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- Sponsor
- Vedic Lifesciences Pvt. Ltd. · Industry
- Sex
- Male
- Age
- 20 Years – 35 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Resistance Training + Placebo (Capsule) + Placebo (Sachet) | * 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. |
| 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 Placebo capsule to be taken 30 minutes after whey protein in the morning |
| DIETARY_SUPPLEMENT | Resistance Training + Whey protein (40 gms) + EB-PA (500 mg) | * 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 |
Timeline
- Start date
- 2023-11-28
- Primary completion
- 2024-03-31
- Completion
- 2024-06-05
- First posted
- 2023-11-13
- Last updated
- 2024-02-01
Locations
3 sites across 1 country: India
Source: ClinicalTrials.gov record NCT06127849. Inclusion in this directory is not an endorsement.