CTRI Number |
CTRI/2019/11/022001 [Registered on: 14/11/2019] Trial Registered Prospectively |
Last Modified On: |
27/01/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [cookies] |
Study Design |
Randomized, Crossover Trial |
Public Title of Study
|
Glycemic index of 3 different cookies |
Scientific Title of Study
|
Glycemic index testing of Cookies |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr V Mohan |
Designation |
Director |
Affiliation |
Madras Diabetes Research Foundation |
Address |
No 6B Conransmith Road Gopalapuram Chennai TAMIL NADU 600086 India |
Phone |
|
Fax |
|
Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person Scientific Query
|
Name |
Ms Sudha Vasudevan |
Designation |
Senior Scientist and Head |
Affiliation |
Madras Diabetes Research Foundation |
Address |
No6B Conransmith Road
Gopalapuram
Chennai TAMIL NADU 600086 India |
Phone |
|
Fax |
|
Email |
s2r_7@mdrf.in |
|
Details of Contact Person Public Query
|
Name |
Ms Sudha Vasudevan |
Designation |
Senior Scientist and Head |
Affiliation |
Madras Diabetes Research Foundation |
Address |
No6B Conransmith Road
Gopalapuram
Chennai TAMIL NADU 600086 India |
Phone |
|
Fax |
|
Email |
s2r_7@mdrf.in |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Hershey India Pvt Ltd |
Address |
Schindler House
Sainath Nagar
Powai
Mumbai 400076
|
Type of Sponsor |
Other [Science based Healthcare products developers ] |
|
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 |
Ms Sudha Vasudevan |
Madras Diabetes Research Foundation |
Department of Foods Nutrition and Dietetics Research
No.6 Conran smith Road Gopalapuram
Chennai 600086 Chennai TAMIL NADU |
9840014480 914428359035 s2r_7@mdrf.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Madras Diabetes Research Foundation Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy human volunteers free from any disease and not under any treatment |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
GI Testing of Cookies |
3 varieties of Cookies each providing 25/50g available carbohydrate will be given. The cookies will be tested on on 3 different days;
Raisin with flax seeds
cocoa with flax seeds
Mango with almond |
Comparator Agent |
Reference Food |
Glucose Providing 25/50g available carbohydrate in 200ml water given 3 different occasion |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
BMI greater than 18.9 to less than 22.9 |
|
ExclusionCriteria |
Details |
Pregnant or lactating Women
BMI greater than 22.9
Thyroid or any other metabolic disorder
Family history of diabetes |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Glycemic index value of cookies |
Each cookies will be tested on separate days for 2hrs (o, 15,30,45,60,90 and 120 mins). Similarly reference foods will be tested on 3 different occasions. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Not applicable |
Not applicable |
|
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)
|
15/11/2019 |
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="0" Months="6" 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)?
|
Brief Summary
|
Research
studies have shown that lifestyle; in particular dietary aspects play an
important role in preventing / increasing the burden of the chronic diseases.
Dietary habits could therefore be modified to prevent and treat diabetes . It
has been suggested that the high glycemic carbohydrate foods – those foods
containing carbohydrates which elicit rapid blood glucose rise and thereby
increase the insulin demand leading to hyperinsulinemia, insulin resistance and
type 2 diabetes. Hence, there is a need to understand the blood glucose raising
potential of foods in India to be of an important tool to aid in the prevention
and or management of diabetes and its complication. Thus evolved the concept of
‘Glycemic Index’ (GI) which ranks the foods, based on the speed at which the
food raises the blood glucose in a scale of 0 to 100, 100 indicating high
glycemic index corresponds to oral glucose’s GI. Today, India leading the world
with the largest number of diabetic volunteers causing a heavy economic burden
to the country urgently needs to look at cost effective strategies to combat
this situation. A cost effective dietary approach like estimating and
understanding the role of glycemic index of various Indian foods in the
lifestyle related diseases like diabetes is urgently needed. Hence in the present study we aim to
evaluate glycemic index (GI) of 3 varieties of Protein cookies with high fibre
and omega 3 fatty acids, provided by Hershey India Pvt .Ltd. (Raisin flaxseeds, cocoa & flaxseeds and Mango almond). |