Evaluating EB-PA's effects 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

This study is testing if a new supplement called EB-PA can help young men who go to the gym occasionally build more muscle and strength.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Male
• Sponsor: Vedic Lifesciences Pvt. Ltd. (industry)
• Locations: 2 sites (Mumbai, Maharashtra and 1 other locations)
• Trial ID: NCT05926609 on ClinicalTrials.gov

What this trial studies

This study is a placebo-controlled, single-blind trial aimed at assessing the efficacy of EB-PA on muscle mass and strength among males aged 18 to 35 who engage in moderate physical activity. A total of 40 participants will be screened, with a target of 30 completing the 60-day treatment period. Participants will be randomly assigned to receive either EB-PA or a placebo, and their muscle mass and strength will be evaluated throughout the study. The study aims to determine if EB-PA can enhance muscle development in individuals who do not regularly participate in resistance training.

Who should consider this trial

Good fit: Ideal candidates are males aged 18 to 35 who have a moderate level of physical activity and have not engaged in structured weight training for the past three months.

Not a fit: Patients who have been involved in structured weight training for more than 12 months or have chronic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new approach for enhancing muscle mass and strength in individuals who engage in occasional gym activities.

How similar studies have performed: While there is limited information on similar studies, the approach of using a supplement like EB-PA for muscle enhancement in non-regular weight trainers is relatively novel.

Eligibility criteria

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

Where this trial is running

Mumbai, Maharashtra and 1 other locations

• Dr. Kumta Solanki's Clinic — Mumbai, Maharashtra, India (NOT_YET_RECRUITING)
• Dr. Preeti Bawaskar's Clinic — Thane, Maharashtra, India (RECRUITING)

Study contacts

• Study coordinator: Dr. Shalini Srivastava, MBBS, MD

Conditions: Muscle Mass and Strength