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
|
|
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
|
|
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. |