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

Study Overview
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Brief Summary
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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.

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

Conditions
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Muscle Mass and Strength

Intervention / Treatment
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* Dietary Supplement: EB-PA
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Single-blind, placebo - controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EB-PA<br>One capsule to be taken after breakfast once a day for 30 days | Dietary Supplement: EB-PA<br>* 1 capsule to be taken after breakfast once a day<br>|
| Placebo Comparator: Placebo<br>One capsule to be taken after breakfast once a day for 30 days | Dietary Supplement: Placebo<br>* 1 capsule to be taken after breakfast once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on | Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion) | Day 31 | 
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on | Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion) | Day 61 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | Increase in the lower-body strength (Peak anaerobic power output (PAPw)) as assessed by a vertical jump test | Day 0, Day 31 and Day 61 | 
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | Improvement in upper body strength as assessed by medicine ball throw test | Day 0, Day 31 and Day 61 | 
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | The flexibility of the hamstrings as assessed using the V sit-and-reach test | Day 0, Day 31 and Day 61 | 
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | Improvement in muscle mass as indicated by an increase in fat-free mass (FFM) by DXA | Day 0, Day 31 and Day 61 | 
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | Decrease in central obesity as indicated by a decrease in android fat percentage by DXA. | Day 0, Day 31 and Day 61 | 
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | Improvement in metabolic health as indicated by the waist-to-height ratio (WHtR) | Day 0, Day 31 and Day 61 | 
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | Improves muscle protein synthesis as assessed by an increase in serum insulin at 0, 1 & 3 hours post IP administration. | Day 0, Day 31 and Day 61 |