| CTRI Number |
CTRI/2024/02/063134 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Biscuits] |
| Study Design |
Other |
|
Public Title of Study
|
Glycemic Index of biscuit (celevida) |
|
Scientific Title of Study
|
Evaluation of Glycemic index of Celevida Biscuits |
| Trial Acronym |
NIL |
|
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 |
Chairman, Madras Diabetes Research Foundation |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No.6B, Conran Smith Road, Gopalapuram,
Chennai
TAMIL NADU
600086
India |
| Phone |
044439688888 |
| Fax |
914428350935 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mohan |
| Designation |
Chairman, Madras Diabetes Research Foundation |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No.6B, Conran Smith Road, Gopalapuram,
Chennai
TAMIL NADU
600086
India |
| Phone |
044439688888 |
| Fax |
914428350935 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sudha Vasudevan |
| Designation |
Senior Scientist and Head- Department of Foods, Nutrition & Dietetics Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No.4, Conran Smith Road, Gopalapuram,
Chennai
TAMIL NADU
600086
India |
| Phone |
984014480 |
| Fax |
914428359035 |
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| Dr. Reddy’s Laboratory Ltd
7-1, 27, Ameerpet Rd, Leelanagar, Ameerpet, Hyderabad, Telangana 500016 |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
No 4, Conran Smith Road,
Gopalapuram, |
| Type of Sponsor |
Research institution |
|
|
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 600086
Chennai
TAMIL NADU |
9840014480
914428359035
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 |
With normal BMI |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Celevida biscuits |
25/ 50 g available carbohydrate providing celevida biscuits will be given to study participants as test food once on a separate day and capillary blood samples will be collected for the subsequent 2 hours. |
| Comparator Agent |
Reference glucose |
25/50g available carbohydrate providing glucose in 125ml/250mlwater is given as reference food three times during the study period
on separate occasions in-between the test foods. Capillary blood samples will be collected for the subsequent 2 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 45 years
BMI greater than equal to 18.5 to less than equal to 22.9 kg/ m2 (as per WHO cut offfor normal BMI)
Both male and female
Willingness to consume the test foods
no known food allergy or intolerance;
no medications known to affect glucose tolerance (excluding oral contraceptives) —stable doses of oral contraceptives, acetylsalicylicacid, thyroxin, vitamins and mineralsupplements or drugs to treat hypertension or osteoporosis are acceptable. |
|
| ExclusionCriteria |
| Details |
a known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin totreat diabetes and related conditions
pregnant or lactating women
a major medical or surgical event requiring hospitalization within the preceding 3months;
the presence of disease or drug(s) which influence digestion and absorption of nutrients;
the use of steroids, protease inhibitors or antipsychotics (all of which have major effectson glucose metabolism and body fat distribution) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic index,Glycemic Response and GI category of food products. |
Glycemic index testing of all foods will be done on separate days. For both intervention and comparator agents capillary blood samples will be collected at -5,0 (fasting state) and at 15,30,45,60,90,120 mins from the first sip of test and reference foods. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
03/03/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 participants 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.
Aim: To measure glycemic index
(GI) of celevida biscuits.
|