CTRI Number |
CTRI/2018/04/012979 [Registered on: 03/04/2018] Trial Registered Retrospectively |
Last Modified On: |
29/03/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [Evaluation of Glycemic Index] |
Study Design |
Randomized, Crossover Trial |
Public Title of Study
|
Effect of a Health food on 2 hours Glucose Response among Overweight Individuals |
Scientific Title of Study
|
Evaluation of Glycemic Index and Satiety of Celevida: Health food for Special Dietary Use |
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 |
President and Chief of Diabetes Research |
Affiliation |
Madras Diabetes Research Foundation |
Address |
Department of Foods, Nutrition and Dietetics Research
Madras Diabetes Research Foundation
No 4, Conran Smith Road Gopalapuram
Chennai TAMIL NADU 600086 India |
Phone |
914439988816 |
Fax |
|
Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person Scientific Query
|
Name |
Mrs Sudha Vasudevan |
Designation |
Senior Scientist & Head- Department of Foods Nutrition & Dietetics Research |
Affiliation |
Madras Diabetes Research Foundation |
Address |
Department of Foods, Nutrition & Dietetics Research,
Madras Diabetes Research Foundation,
No 4, Conran Smith Road Gopalapuram
Chennai TAMIL NADU 600086 India |
Phone |
04443968487 |
Fax |
914428359035 |
Email |
s2r_7@mdrf.in |
|
Details of Contact Person Public Query
|
Name |
Mrs Sudha Vasudevan |
Designation |
Senior Scientist & Head- Department of Foods Nutrition & Dietetics Research |
Affiliation |
Madras Diabetes Research Foundation |
Address |
Department of Foods, Nutrition & Dietetics Research,
Madras Diabetes Research Foundation,
No 4, Conran Smith Road Gopalapuram
Chennai TAMIL NADU 600086 India |
Phone |
04443968487 |
Fax |
914428359035 |
Email |
s2r_7@mdrf.in |
|
Source of Monetary or Material Support
|
Dr. Reddys Laboratories Ltd.
7-1-27, Greenlands, Ameerpet, Hyderabad 500016
|
|
Primary Sponsor
|
Name |
Madras Diabetes Research Foundation |
Address |
Department of Foods Nutrition & Dietetics Research
No 4, Conran Smith Road Gopalapuram
Chennai
|
Type of Sponsor |
Other [Non Government Research Organisation] |
|
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 V Mohan |
Madras Diabetes Research Foundation |
Department of Foods Nutrition & Dietetics Research
No 4 Conran Smith Road Gopalapuram
Chennai
Chennai TAMIL NADU |
914439988816
drmohans@diabetes.ind.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 |
Male and female overweight individuals (BMI greater than or equal to 22.9) |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Celevida |
2 variants of Celevida (Rasamalai and Chocolate flavours) each mixed with water and milk will be given to study participants |
Comparator Agent |
Reference Glucose |
Glucose is given as reference food thrice during the study period |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
1.BMI greater than or equal to 22.9 kg/ m2
2.Participants with family history of diabetes
3.Willingness to consume the test foods
|
|
ExclusionCriteria |
Details |
1.Underweight
2.Specific diet restriction (weight reduction, low fat, salt restriction diet)
3.Suffering from any chronic illness or medical condition (Heart disease, diabetes, high blood pressure, renal or kidney disease, anaemia)
4.Pregnant and lactating mother
5.Food allergy
6.Physically challenged |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Assessing the glycemic index, GI category and satiety of food products |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Assessing the proximates and available carbohydrates of food products |
7 days |
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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)
|
16/03/2018 |
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="15" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Not yet |
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
exert a positive impact in the prevention and treatment. 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 need 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. Capillary blood
glucose will be measured at 0, 15, 30, 45, 60, 90 and 120 min using Hemocue
Glucose 201+ analyzer (Hemocue®Ltd,
Angelholm, Sweden). Standard glucose drink will be given for 3 different
days to get average glucose response and each test food for 1 day with a wash
out period of 2 to 3 days between each test day. The GI was calculated as IAUC
of test food/IAUC of reference (Glucose) food x 100.
|