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CTRI Number  CTRI/2022/01/039219 [Registered on: 06/01/2022] Trial Registered Prospectively
Last Modified On: 03/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Trial of a protein supplement in improving health and wellbeing 
Scientific Title of Study   Clinical validation of NRL/2019/NMP with micronutrient fortification to assess the efficacy and safety in promoting health and wellbeing in healthy adults - Randomized placebo controlled trial.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/21-22/015 Ver.1 dated 8th Nov 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V G Vaidya 
Designation  Managing Trustee 
Affiliation  Lokmanya Medical Research Centre 
Address  Second floor Lokmanya Hospital 314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  9822057766  
Fax    
Email  vgvclinical@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Priya Khare 
Designation  Assistant Manager R and D Healthcare 
Affiliation  Netsurf communication pvt ltd 
Address  Survey No 107 Plot No 2 Baner Rd Laxman Nagar Baner Pune Maharashtra 411045

Pune
MAHARASHTRA
411045
India 
Phone  8329486883  
Fax    
Email  priya.khare@netsurfnetwork.com  
 
Details of Contact Person
Public Query  
Name  Dr Pranit Ambulkar 
Designation  Senior Manager R and D Healthcare 
Affiliation  Netsurf communication pvt ltd 
Address  Survey No 107 Plot No 2 Baner Rd Laxman Nagar Baner Pune Maharashtra 411045

Pune
MAHARASHTRA
411045
India 
Phone  9785587317  
Fax    
Email  pranit.a@netsurfnetwork.com  
 
Source of Monetary or Material Support  
Netsurf Communications Pvt Ltd 107 Plot 2 Laxman Nagar Baner Road Baner Pune 411045 Maharashtra India 
 
Primary Sponsor  
Name  Netsurf Communications Pvt Ltd 
Address  107 Plot 2 Laxman Nagar Baner Road Baner Pune 411045 Maharashtra India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramshyam C Agarwal  Health Nexus  1st Floor, Mangal Corner, next to Vedant Hospital, Thermax Chowk, Chinchwad 411018
Pune
MAHARASHTRA 		 8087282022

ramshyamagarwal20@gmail.com 
Dr V G Vaidya  Lokmanya Medical Research Centre and Hospital  Forth floor, LHCC building, 401 OPD, 314/B Telco Road, Chinchwad Pune 411033
Pune
MAHARASHTRA 		 9822057766

vgvclinical@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre   Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health and Well being 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NRL/2019/NMP   20 g in 200 ml milk once a day for 90 days 
Comparator Agent  placebo   20 g in 200 ml milk once a day for 90 days. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Age group: 25-45 years
2.BMI in the range of 20-26
3.Subjects in good physical condition and sound mental status.
4.In the judgment of the Principal Investigator, able to comply with protocol requirements.
5.Subjects willing to sign written informed consent
6.Willingness to abstain from use of vitamin or mineral supplements, nutritional supplements and or medical foods if applicable.
 
 
ExclusionCriteria 
Details  1.Allergies to ingredients in product/ milk
2.Subjects with uncontrolled and complicated diabetes (HbA1C NMT 5.7% and blood pressure NMT 140/90 mm hg) may or may not be on prescription.
3.Subjects with past history of addiction abuse and rehabilitation
4.Subject more than 2 events of alcohol consumption per week
5.Subjects with current medical history of any major illness such as cancer, heart disease, COPD , Asthma etc. in the past
6.Subjects with history of any acute or chronic illness that may affect the patient’s participation in the study
7.Use of prescription medications and/or nonprescription medications for weight loss.
8.Subjects with acute illness or history of major or minor surgery in the past one year.
9.Female subjects who are currently pregnant and/or breast feeding
10.Subjects not willing to participate in study
11.Subjects with deranged LFT and KFT as per investigator discretion
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Changes mean in total General Health Questionnaire-28 (GHQ-28) score.
Changes in mean serum total protein, and albumin to globulin ratio.
Changes in mean calculated VO2 max by 6-minute walk test.
Changes in mean BMI, fat %, skeletal muscle %, through impedance studies for body composition along with waist and hip circumferences. 		 Screening Baseline Day 30 Day 60 Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in % responders (subjects showing reduction of 25% of low energy scores in 30 days’ time) on daily energy questionnaire.
Changes in mean total digestive behavior score.
Changes in mean total sleep quality score.
Changes in mean Bone Mineral content, Bone mineral density, fat content analyzed by DXA scanning for body composition.  		 Screening Baseline Day 30 Day 60 Day 90 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   09/01/2022 
Date of Study Completion (India) 23/08/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The purpose of the research is evaluating safety and efficacy of protein supplement NRL/2019/NMP for improving health and wellbeing in healthy individuals. The product is composed of plant based proteins, micronutrients like vitamins, minerals and probiotics like Bifidobacterium, Lactobacillus together with some specialized natural ingredients like Colostrum, Omega 3 DHA, Aloe Vera and Zeaxanthin etc. By virtue of the selection of the ingredients, NRL/2019/NMP may provide health benefits to improve quality of life, energy, endurance and digestive behavior.

 
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