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

Not Applicable

Recruiting

• Conditions: Muscle Mass and Strength
• Interventions: Dietary Supplement: EB-PA; Dietary Supplement: Placebo

• Registration Number: NCT05926609
• Lead Sponsor: Vedic Lifesciences Pvt. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Study Start: 2023-07-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
EB-PA	EB-PA	One capsule to be taken after breakfast once a day for 30 days
Placebo	Placebo	One capsule to be taken after breakfast once a day for 30 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Improves muscle protein synthesis as assessed by an increase in serum insulin at 0, 1 \& 3 hours post IP administration.

Trial Locations

Locations (2)

Dr. Preeti Bawaskar's Clinic; 🇮🇳 Thane, Maharashtra, India

Dr. Kumta Solanki's Clinic; 🇮🇳 Mumbai, Maharashtra, India