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

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.

Study Overview

• Status: Recruiting
• Conditions: Muscle Mass and Strength
• Intervention / Treatment: Dietary supplement: EB-PA; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Sonali Ghosh, BAMS; Phone Number: 02242172300; Email: sonali.g@vediclifesciences.com
• Study Contact Backup: Name: Dr. Shalini Srivastava, MBBS, MD; Phone Number: 02242172300; Email: shalini.s@vediclifesciences.com

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400053
      • Not yet recruiting
      • Dr. Kumta Solanki's Clinic
      • Contact: Dr. Kumta Solanki, BAMS, MD; Phone Number: +919820511900; Email: drkumtamali0607@gmail.com
    • Thane, Maharashtra, India, 400607
      • Recruiting
      • Dr. Preeti Bawaskar's Clinic
      • Contact: Dr. Preeti Bawaskar, BAMS, MD; Phone Number: +919146680080; Email: preeti.bawaskar10@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EB-PA; One capsule to be taken after breakfast once a day for 30 days	Dietary supplement: EB-PA; 1 capsule to be taken after breakfast once a day
Placebo Comparator: Placebo; One capsule to be taken after breakfast once a day for 30 days	Dietary supplement: Placebo; 1 capsule to be taken after breakfast once a day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: EB/230201/EB-PA/MMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No