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CTRI Number  CTRI/2025/11/097046 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 05/11/2025
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study to find out how MB EnzymePro® Capsule affects the absorption of whey protein in healthy adult men under fasting conditions. 
Scientific Title of Study   An open label, balanced, randomized, two-arm, two-period, crossover, oral bio-study to determine the effect of MB EnzymePro® Capsule on bioavailability of whey protein in healthy, adult, human male participants under fasting condition. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
VRL-25-064 Version 01 Dated 08-Oct-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Avinash Andhale 
Designation  Principal Investigator 
Affiliation  Vivotech Research Lab Pvt. Ltd. 
Address  Vivotech Research Lab Pvt. Ltd. Plot No. D-17/4, TTC Industrial area, Turbhe MIDC,Navi Mumbai, Maharashtra, India 400703

Mumbai
MAHARASHTRA
400703
India 
Phone  9987598349  
Fax    
Email  pi@vivotechresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj K Verma 
Designation  AVP/Head R&D 
Affiliation  Bright Lifecare Pvt. Ltd. (Healthkart) 
Address  Bright Lifecare Pvt. Ltd. (Healthkart) Tower B, Second Floor, 46/4, M G ROAD, SECTOR-14, Opp. Girls Collage, GURUGRAM, Gurugram, Haryana, 122001 Gurgaon HARYANA 122001 India

Gurgaon
HARYANA
122001
India 
Phone  8283816435  
Fax    
Email  manoj.verma@brightlifecare.com  
 
Details of Contact Person
Public Query  
Name  Mr Manoj Karwa 
Designation  Head Clinical Trial & Pharmacovigilance 
Affiliation  Auriga Research Private Limited 
Address  Auriga Research Pvt Ltd., 136, Sector 5, IMT Manesar, Gurugram, Haryana 122050 Gurgaon HARYANA 122050 India

Gurgaon
HARYANA
122050
India 
Phone  9313367656  
Fax    
Email  manojkarwa@aurigaresearch.com  
 
Source of Monetary or Material Support  
Bright Lifecare Pvt. Ltd. (Healthkart), Tower B, Second Floor, 46/4,, M G ROAD, SECTOR-14, Opp. Girls Collage, GURUGRAM, Gurugram, Haryana, 122001 
 
Primary Sponsor  
Name  Bright Lifecare Pvt. Ltd. (Healthkart) 
Address  Tower B, Second Floor, 46/4,, M G ROAD, SECTOR-14, Opp. Girls Collage, GURUGRAM, Gurugram, Haryana, 122001 
Type of Sponsor  Other [Nutraceutical Company] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Avinash Andhale  Vivotech Research Lab Pvt. Ltd.  Plot No. D-17/4, TTC Industrialarea, Turbhe MIDC, Navi Mumbai,Maharashtra, India-400703 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 9987598349

pi@vivotechresearch.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vision Independent Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adult healthy male subjects under fasting condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Flavored Whey Protein  Flavored Whey Protein, 50 g will be administered orally with 360 ± 2 mL of water after an overnight fast. Each participant will receive a single oral dose in each study period as per the randomization schedule, under supervision of study personnel. 
Intervention  Flavored Whey Protein 50g +MB EnzymePro® Capsule 260mg  The test product (Flavored Whey Protein + MB EnzymePro® Capsule) and control product (Flavored Whey Protein, 50 g) will be administered orally with 360 ± 2 mL of water after an overnight fast. Each participant will receive a single oral dose in each study period as per the randomization schedule, under supervision of study personnel. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Male 
Details  1. Able to read and understand and ready to provide written informed
consent.
2. Healthy adult male human beings within the age of 18 to 35 years.
3. Having A Body Mass Index (BMI) in the range 20.0 to 24.0 kg per m2
and weight at least 50 kg.
4. Must be of normal health as determined by medical history and
physical examination, ECG and laboratory tests performed within
28 days prior to the commencement of the study.
5. Chest X-ray is normal or considered by the physician or Principal
Investigator to be of no clinical significance.
6. Screening laboratory values are within normal limits or considered
by the physician or Principal Investigator to be of no clinical
significance.
7. Non-weight training participant who agrees not to begin a new
exercise program during the course of the study. 
 
ExclusionCriteria 
Details  1. Known hypersensitivity or idiosyncratic reaction or intolerance to MB EnzymePro® or Protein diet or any ingredients of the formulation
or any related products as well as severe hypersensitivity reactions
(like angioedema) to any drugs or food products.
2. Positive Breath Alcohol Analysis or Urine Drug Screen (UDS)
before admission in Period-I of the study.
3. Resting hypotension (BP less than 90 to 60) or hypertension (BP more than 139 to 89).
4. Pulse rate below 50 per min. and above 99 per min.
5. Clinically significant abnormal lab values or abnormal ECG and
Chest X Ray.
6. Presence of disease markers of HIV 1 or 2, Hepatitis B or C
viruses, and syphilis.
7. History of Myocardial Infarction, Stroke, Peripheral Arterial
Disease, GI Bleeding, Hepatic Impairment, Renal Impairment,
Epilepsy and Intracranial hemorrhage.
8. History of known food allergy.
9. History of drug abuse or alcoholism i.e. alcohol consumption more than 2 units per day or 10 units per week (one unit of alcohol 50 ml spirit or 200 ml wine or 500ml beer).
10. History of smoking or tobacco consumption
11. History of allergy to heparin, preservatives, dyes.
12. Intake or administered protein supplements or any drugs or over
the counter or prescribed medications including any enzyme
modifying drugs within the last 14 days prior to the study drug
administration in the study.
13. Suffered with any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
14. History or presence of significant gastrointestinal, liver or kidney disease, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
15. Presence of active peptic ulceration or a history of peptic
ulceration.
16. History of clinically significant, Cardiovascular, pulmonary,
hepatic, renal, hematological, gastrointestinal, endocrine,
immunologic, dermatologic, musculoskeletal, neurological or
psychiatric disease.
17. Participated in any other clinical trial requiring repeated blood sampling or a blood donation program or blood loss of more than 350 ml, in the past three months (approx. 90 days) (This 350 mL
includes the total blood loss that will occur during the study).
18. Difficulty with donating blood.
19. Difficulty in swallowing of Capsules.
20. Following any particular protein rich dietary regime, muscle
toning or body building program or not willing to discontinue such
regime or program during the conduct of study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the effect of MB EnzymePro®, capsule on bioavailability of whey protein in healthy human male participants. This study is intended to show the effect of MB EnzymePro® capsule with whey protein as compare to Control Group with whey protein only on the percentage enhancement of amino acid levels i.e. enhancement of bioavailability of protein.  00.00, 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 02.00, 03.00 and 04.00 hrs. in both period 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety of the product by monitoring vital signs, conducting pre and post treatment laboratory assessments, and
recording any adverse events throughout the study period any gastric discomfort after product administration. 		 00.00, 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 02.00, 03.00 and 04.00 hrs. in both period 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

This is an open-label, balanced, randomized, two-arm, two-period, crossover, oral bioavailability study designed to determine the effect of MB EnzymePro® Capsule on the bioavailability of whey protein in healthy adult male participants under fasting conditions.

A total of 84 healthy adult males aged 18–35 years will be enrolled. Participants will receive either MB EnzymePro® Capsule (260 mg enzyme blend) administered along with 50 g flavored whey protein (Test) or whey protein alone (Control) in two treatment periods separated by a 5-day washout. The study will be conducted under controlled fasting conditions.

The primary objective is to evaluate the effect of MB EnzymePro® Capsule on the bioavailability of whey protein by comparing changes in plasma amino acid concentrations between the test and control groups. The study also aims to assess whether MB EnzymePro® enhances in-vivo protein absorption and influences nitrogen balance and C-reactive protein (CRP) levels.

The secondary objective is to evaluate the safety and tolerability of MB EnzymePro® Capsule through monitoring of vital signs, ECG, laboratory investigations, and adverse events during the study.

 
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