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CTRI Number  CTRI/2023/11/060027 [Registered on: 20/11/2023] Trial Registered Prospectively
Last Modified On: 31/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth 
Scientific Title of Study   A Randomized, Placebo-controlled, Blinded Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
EB/230701/EB-PA/SMSG, Version no. 1.0, Date: Oct 21, 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalini Srivastava 
Designation  Director Clinical Development 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  B-118, Morya House, Off New Link Road, Andheri West, Mumbai, MAHARASHTRA - 400053, India.

Mumbai
MAHARASHTRA
400053
India 
Phone  02242172300  
Fax    
Email  shalini.s@vediclifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalini Srivastava 
Designation  Director Clinical Development 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  B-118, Morya House, Off New Link Road, Andheri West, Mumbai, MAHARASHTRA - 400053, India.

Mumbai
MAHARASHTRA
400053
India 
Phone  02242172300  
Fax    
Email  shalini.s@vediclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonali Ghosh 
Designation  Project Lead 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  B-118, Morya House, Off New Link Road, Andheri West, Mumbai, MAHARASHTRA - 400053, India.

Mumbai
MAHARASHTRA
400053
India 
Phone  02242172300  
Fax    
Email  sonali.g@vediclifesciences.com  
 
Source of Monetary or Material Support  
Vedic Lifesciences Pvt. Ltd, B-118, Morya House, Off New Link Road, Andheri West, Mumbai - 400053 
 
Primary Sponsor  
Name  Vedic Lifesciences Pvt. Ltd 
Address  B-118, Morya House, Off New Link Road, Andheri West, Mumbai - 400053. 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sunira Khare  Dr. Khares Clinic  118 - B wing, Morya house, New link road, Andheri west, India -400053
Mumbai
MAHARASHTRA 		 9664056580

sunira.khare@gmail.com 
Dr Preeti Bawaskar  Kalpna Ayurvedic Clinic  102, Ace business Center Gokulnagar Thane west, India
Mumbai
MAHARASHTRA 		 9146680080

preeti.bawaskar10@gmail.com 
Dr Anand Yadav  Nirmala Clinic  Shop No. - 1, Near Anmol Dairy Farm, Opp. Maharashtra Store, Jetvan Buddha Vihar Road, Hanuman Nagar, Kandivali - East, Mumbai - 400101.
Mumbai (Suburban)
MAHARASHTRA 		 9594619143

ay19891711@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Altezza Ethics Committee   Approved 
Altezza Ethics Committee  Approved 
Altezza Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Skeletal Muscle Strength & Growth 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  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 
Intervention  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 
Comparator Agent  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 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Male 
Details  1. Males aged 20 to 35 years with active lifestyle with moderate physical activity level as per International Physical Activity Questionnaire
2. Recreationally gym goer with history of at least 1 month of endurance training (Example - functional exercises)
3. Not participating in resistance type training (Example external or body weight training) for less than equal to 3 months prior to screening
4. Body mass index (BMI) 22 to 29.9 kg/m2.
5. Individuals with a 1-RM strength defined by Upper Body more than equal to 25 Kgs and Lower Body more than Equal to 100 Kgs will be included in the study
6. Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs prior to the exercise lab visit
7. Fasting Blood Glucose Less than Equal to 110 mg/ dl.
8. Systolic Blood Pressure less than equal to 129 mmHg and Diastolic Blood Pressure Less than equal to 89 mmHg
9. TSH (thyroid stimulating hormone) more than equal to 0.4 and Less than Equal to 4.9 mIU/L. 
 
ExclusionCriteria 
Details  1. Engaged in structured weight training for more than 3 months prior to screening.
2. Presence of chronic disease.
3. Changes in body weight more than 4.5 kg (10 pounds) in the past three months as assessed by history.
4. Subjects diagnosed with hypertension.
5. Subjects who are diagnosed with Type I and Type II Diabetes Mellitus.
6. History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders.
7. Allergy to whey protein or herbal ingredients.
8. Subjects who have any other disease or condition, or are using any medication, that in the judgement 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.
9. Subjects who have been part of a clinical study within 90 days prior to the screening.
10. Subjects who have used whey or other supplemental proteins anytime in the last 3 months.  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess improvement in muscle strength after administration of Investigational Product (IP) as assessed by increase in Upper & lower body 1RM (Repetition Maximum) weight   Day 0 to Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of IP on increase in muscle endurance as assessed by increase in exercise volume calculated as load multiplied by number of repetition (upper and lower body exercise) completed at more than equal to 70 percent of Screening 1 RM.   Day 0 to Day 30 
To assess the effect of OP on Increase in muscle (hamstring) flexibility as assessed by increase in distance for V sit and reach test.  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.   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.   Day 0 to Day 30 
To assess the effect of IP on improvement in metabolic health as indicated by waist to height ratio.  Day 0 to Day 30 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   25/11/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
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