MedTrace Logo

A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth

NCT06127849 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-02-01

No results posted yet for this study

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

  • Skeletal Muscle Strength & Growth

Interventions

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

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2024-03-31
Completion
2024-06-05

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127849 on ClinicalTrials.gov