A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth

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

The present study is a randomized, placebo-controlled, double blinded study to evaluate efficacy of EB-PA as protein amplifier for skeletal muscle strength & growth in males with active lifestyle. Approximately 160 subjects aged between ≥ 20 and ≤ 35 years will be screened and 138 participants are to be randomized. Both the IP and placebo study arms will have at least 40 completed subjects after accounting for the screening failure and dropout/withdrawal rate of 14% and 13 % respectively (Total 120 completers). The treatment duration for all the study subjects will be 30 days. The sustained effect of the product will be observed for next 7 days, wherein, the subjects will be abstaining from the protein and IP supplementation and will exercise at their ease.

Study Overview

• Status: Recruiting
• Conditions: Skeletal Muscle Strength & Growth
• Intervention / Treatment: Dietary supplement: Resistance Training + Placebo (Capsule) + Placebo (Sachet); Dietary supplement: Resistance Training + Whey protein (40 gms) + Placebo (Capsule); Dietary supplement: Resistance Training + Whey protein (40 gms) + EB-PA (500 mg)

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400053
      • Recruiting
      • Dr. Khare's Clinic
      • Contact: Dr. Sunira Khare, BHMS; Phone Number: +919664056580; Email: sunira.khare@gmail.com
    • Mumbai, Maharashtra, India, 400101
      • Recruiting
      • Nirmala Clinic
      • Contact: Dr. Anand Yadav, BAMS, MD; Phone Number: +919594619143; Email: ay19891711@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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Resistance Training + Placebo (Capsule) + Placebo (Sachet); A sachet of 20 gms of Placebo dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of placebo to be taken 30 minutes after placebo sachet in the morning.	Dietary supplement: Resistance Training + Placebo (Capsule) + Placebo (Sachet); Placebo sachet of 20 gms dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening.; One Placebo capsule to be taken 30 minutes after sachet in the morning.
Active Comparator: Resistance Training + Whey protein (40 gms) + Placebo (Capsule); A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of Placebo to be taken 30 minutes after whey protein in the morning.	Dietary supplement: Resistance Training + Whey protein (40 gms) + Placebo (Capsule); A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. - One Placebo capsule to be taken 30 minutes after whey protein in the morning
Active Comparator: Resistance Training + Whey protein (40 gms) + EB-PA (500 mg); A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of EB0-PA to be taken 30 minutes after whey protein in the morning.	Dietary supplement: Resistance Training + Whey protein (40 gms) + EB-PA (500 mg); A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening.; One capsule of EB-PA to be taken 30 minutes after whey protein in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess improvement in muscle strength after administration of Investigational Product (IP) as assessed by increase in lower body 1 RM (repetition maximum) weight from baseline.	The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].	Day 30
To assess improvement in muscle strength after administration of Investigational Product (IP) as assessed by increase in upper body 1 RM (repetition maximum) weight from baseline.	The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the effect of Investigational Product (IP) on Increase in muscle endurance as assessed by increase in exercise volume calculated as load x number of repetition (upper + lower body exercise) completed at ≥70% of screening 1-RM.	The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].	Day 0 to Day 30
To assess the effect of Investigational Product (IP) on Increase in muscle (hamstring) flexibility as assessed by increase in distance for V sit & reach test.	V sit and reach test is performed to measure the flexibility of the lower back and back thigh muscles.	Day 0 to Day 30
To assess the effect of IP on improvement in muscle mass as indicated by increase in fat free mass (FFM), lean muscle mass and android fat by DXA.	Total body scans will be performed using a device with its scan mode already determined automatically by the device operating system within the manufacture specification.	Day 0 to Day 30
To assess the effect of IP on improvement in grip strength as indicated by increase in non-dominant hand grip strength.	Each subject will perform the test three times approximately with 25±5 sec relaxations between the session. The participant should be instructed to squeeze the dynamometer until the grip is stable. For 3 sets, the reading will be noted in Kg and an average of 3 readings will be calculated.	Day 0 to Day 30
To assess the effect of IP on Improvement in metabolic health as indicated by waist to height ratio.	Waist circumference (WC) will be measured at the end of a normal expiration using a non-stretchable measuring tape.	Day 0 to Day 30
To assess the sustained effect of IP on muscle strength as assessed by Maintenance of lower body 1 RM weight	The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].	Day 30 To 37
To assess the sustained effect of IP on muscle strength as assessed by Maintenance of upper body 1RM weight	The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].	Day 30 To 37

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): June 5, 2024

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EB/230701/EB-PA/SMSG

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