Evaluating a protein amplifier for improving muscle strength and growth

A Randomized, Placebo-controlled, Blinded Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth

This study is testing if a new protein booster can help young active men build muscle strength and size when combined with resistance training.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 20 Years to 35 Years
• Sex: Male
• Sponsor: Vedic Lifesciences Pvt. Ltd. (Industry-sponsored)
• Locations: 3 sites (Mumbai, Maharashtra and 2 other locations)
• Trial ID: NCT06127849 on ClinicalTrials.gov

What this trial studies

This study is a randomized, placebo-controlled, double-blinded trial aimed at assessing the efficacy of EB-PA as a protein amplifier for enhancing skeletal muscle strength and growth in active males aged 20 to 35. Approximately 160 subjects will be screened, with 138 participants randomized into different treatment arms involving resistance training combined with either whey protein or placebo. The treatment duration is set for 30 days, followed by a 7-day observation period to assess the sustained effects of the intervention. Participants will be required to abstain from protein and supplementation during this observation phase while engaging in light exercise.

Who should consider this trial

Good fit: Ideal candidates are males aged 20 to 35 with an active lifestyle and a history of moderate physical activity, specifically those who have not engaged in resistance training for the past three months.

Not a fit: Patients who have been involved in structured weight training for more than three months prior to screening may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved muscle strength and growth in young males, enhancing their physical performance and overall fitness.

How similar studies have performed: While this approach is novel, similar studies evaluating protein supplementation in conjunction with resistance training have shown promising results in enhancing muscle growth.

Eligibility criteria

Inclusion Criteria:

* Males aged 20 - 35 years with active lifestyle with moderate physical activity level as per International Physical Activity Questionnaire.
* Recreationally gym goer with history of at least 1 month of endurance training (E.g.: functional exercises)
* Not participating in resistance type training (E.g.: external or body weight training) for ≥3 months prior to screening.
* Body mass index (BMI) 22 - 29.9 kg/ m2.
* Individuals with a 1-RM strength defined by Upper Body ≥ 25 Kgs and Lower Body ≥ 100 Kgs will be included in the study.
* Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs prior to the exercise lab visit.
* Fasting Blood Glucose ≤ 110 mg/ dl.
* Systolic Blood Pressure ≤ 129 mmHg and Diastolic Blood Pressure ≤ 89 mmHg.
* TSH (thyroid stimulating hormone) ≥ 0.4 and ≤ 4.9 mIU/L.

Exclusion Criteria:

* Engaged in structured weight training for more than 3 months prior to screening.
* Presence of chronic disease.
* Changes in body weight more than 4.5 kg (10 pounds) in the past three months as assessed by history.
* Subjects diagnosed with hypertension.
* Subjects who are diagnosed with Type I Diabetes Mellitus and Type II Diabetes Mellitus.
* History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders.
* Allergy to whey protein or herbal ingredients.
* Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put them at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
* Subjects who have been part of a clinical study within 90 days prior to the screening.
* Subjects who have used whey or other supplemental proteins anytime in last 3 months.

Where this trial is running

Mumbai, Maharashtra and 2 other locations

• Dr. Khare's Clinic — Mumbai, Maharashtra, India (Recruiting)
• Nirmala Clinic — Mumbai, Maharashtra, India (Recruiting)
• Dr. Preeti Bawaskar's Clinic — Thane, Maharashtra, India (Recruiting)

Study contacts

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

Conditions Skeletal Muscle Strength & Growth