A Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goers

A Placebo-Controlled, Single-Blind Sequential Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goer

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05926609

Enrollment

Registered

2023-07-03

Start date

2023-07-27

Completion date

2023-12-15

Last updated

2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Mass and Strength

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTEB-PA

1 capsule to be taken after breakfast once a day

DIETARY_SUPPLEMENTPlacebo

1 capsule to be taken after breakfast once a day

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Intervention model description

Single-blind, placebo - controlled trial

Eligibility

Sex/Gender

MALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Males aged ≥18 to ≤ 35 years with moderate physical activity levels as per International Physical Activity Questionnaire (IPAQ-SF). * Occasionally gym goer with a history of at least 1 month of training but not participating in the resistance-type activity for ≥3 months. * Habitual non-veg eater * Body mass index (BMI) 22 - 29.9 kg/ m2 * Waist Circumference 94-102 cm * Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs before the exercise lab visit. * Fasting blood Glucose ≤ 125 mg/ dl * Systolic Blood Pressure ≤ 129 mm Hg and Diastolic Blood Pressure ≤ 89 mm Hg * TSH (thyroid stimulating hormone) ≥0.4 and ≤ 4.9 mIU/L

Exclusion criteria

* Engaged in structured weight training for more than 12 months before screening. * Presence of chronic disease * Changes in body weight of more than 4.5 kg (10 pounds) in the past three months * Individuals with uncontrolled hypertension * Known cases of Type II Diabetes mellitus * History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders * Individuals who have any other disease or condition or are using any medication that, in the investigator's judgment would put them at unacceptable risk for participation in the study or may interfere with evaluations or non-compliance with treatment or visits * Individuals who have been part of a clinical trial within 90 days before the screening * Individuals who have used whey or other supplements anytime in the last 3 months

Design outcomes

Primary

Measure	Time frame	Description
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on	Day 31	Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion)

Secondary

Measure	Time frame	Description
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on	Day 0, Day 31 and Day 61	Increase in the lower-body strength (Peak anaerobic power output (PAPw)) as assessed by a vertical jump test

Countries

India

Contacts

Primary ContactDr. Shalini Srivastava, MBBS, MD

shalini.s@vediclifesciences.com02242172300

Backup ContactDr. Sonali Ghosh, BAMS

sonali.g@vediclifesciences.com02242172300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026