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CTRI Number  CTRI/2018/03/012426 [Registered on: 08/03/2018] Trial Registered Retrospectively
Last Modified On: 16/04/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study to compare soy and milk protein effects on glucose regulation and appetite among healthy Indians 
Scientific Title of Study   A Pilot study to examine the effects of isolated soy protein (ISP) and whey protein (WP) on glucose homeostasis and satiety in normal healthy weight Indian men 
Trial Acronym  Soy and whey 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sucharita S 
Designation  Additional Professor 
Affiliation  St Johns Medical College 
Address  Department of Physiology St Johns Medical College Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  08049466324  
Fax    
Email  sucharita.dr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sucharita S 
Designation  Additional Professor 
Affiliation  St Johns Medical College 
Address  Department of Physiology St Johns Medical College Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  08049466324  
Fax    
Email  sucharita.dr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rebecca Kuriyan Raj 
Designation  Associate Professor 
Affiliation  St Johns Medical College and St Johns Research Institute 
Address  Department of Physiology and Division of Nutrition St Johns Medical College Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  08049467001  
Fax    
Email  rebecca@sjri.res.in  
 
Source of Monetary or Material Support  
DuPont Knowledge Centre E.I DuPont India Limited Dupont Knowledge centre (DKC) Survey No.542/2.DS-9,IKP Knowledge Park Ranga REddy District, Turkapally, Hyderabad-500078, Telangana India  
 
Primary Sponsor  
Name  Dr Neeraj Pandey 
Address  DuPont Knowledge Centre E.I DuPont India Limited Dupont Knowledge centre (DKC) Survey No.542/2.DS-9,IKP Knowledge Park Ranga REddy District, Turkapally, Hyderabad-500078, Telangana India 
Type of Sponsor  Other [DuPont Knowledge Center, is integrated science and technology center, E.I DuPont India Pvt Ltd] 
 
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 Sucharita S  St.Johns Medical College  Room no 403, Department of Physiology, Johnnagar Koramangala
Bangalore
KARNATAKA 
08049466322

sucharita@stjohns.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers between 20 and 35 years of age, Normal BMI, without history of soy or whey protein allergy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  soy protein, whey protein  soy protein 15 percent and 30 percent whey protein 15 percent and 30 percent 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Male 
Details  BMI range 18.5 to 25 Kg/m2
 
 
ExclusionCriteria 
Details  1.history of diabetes,hypertension, any chronic illness,
2. history of soy or whey protein allergy
3. acute illness within the last 2 weeks
4. involved in competitive sports
5. Altered sleep/ eating schedules
6. Weight loss or again in the past six months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Glycemic and insulinemic response following WP (15% Vs 30%) and ISP (15% Vs 30%).
Satiety scores 
Blood samples for glycemic and insulinemic response: -10, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300 mins
Satiety test: Basal,10,40,70,100,130,160,190,220,250,300 mins
 
 
Secondary Outcome  
Outcome  TimePoints 
Indirect calorimetry (VO2, VCO2, RQ and EE)
 
Indirect Calorimetry : Basal, 60 , 120, 180, 240, 300 mins
 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/06/2015 
Date of Study Completion (India) 21/09/2015 
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   Publication in preparation 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

High quality protein intake has been linked to positive outcomes (growth and development, muscle mass improvement etc.,) from children to elderly population. Increased probability of greater fat loss with improvement in lean mass is some of the supporting findings with high protein intake. Data from diabetic population has also supported the role of greater protein intake on glucose homeostasis. However, currently there is lack of understanding, particularly in terms of the type and the level of protein intake on glucose homeostasis in Indian population. This is of relevance particularly in an Indian scenario, where susceptibility to develop chronic diseases like diabetes is high. In addition, majority of the Indians practice vegetarianism and even when they consume non-vegetarian based diet quantity and quality of meal protein is disputed. Current study  is an attempt to explore the effects of 2 types of protein (whey protein (WP) and isolated soy protein (ISP)) and 2 levels of protein (15 and 30% Energy) on glucose homeostasis and satiety in Indian healthy subjects. Any positive outcomes from this pilot study will have wider implication in a clinical setting for instance type 2 diabetes where effects might be far better and of greater relevance. Further, this could also help derive at a standard practice of protein supplementation not only in healthy but also in various clinical states.

 
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