| CTRI Number |
CTRI/2022/08/044581 [Registered on: 02/08/2022] Trial Registered Prospectively |
| Last Modified On: |
28/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cereal and pulse based foods] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Glycemic index testing of cereals and pulse based foods |
|
Scientific Title of Study
|
Evaluation of Glycemic Index of cereal grains and pulses-based products(n=5) |
| Trial Acronym |
NA |
|
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 & Chief of Diabetes Research |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
6B Conron Smith Road,Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
|
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudha Vasudevan |
| Designation |
Sr. Scientist and Head |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
6B Conron Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
|
| Fax |
|
| Email |
s2r_7@mdrf.in |
|
Details of Contact Person
Public Query
|
| Name |
Sudha Vasudevan |
| Designation |
Sr. Scientist and Head |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
6B Conron Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
|
| Fax |
|
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| Community Science College and Research Institute
Tamil Nadu Agricultural University
Madurai |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
No 6B Conran Smith Road, Gopalapuram
Chennai-600086 |
| 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 |
| Sudha Vasudevan |
Madras Diabetes Research Foundation |
6B Conron Smith Road
Gopalapuram
Chennai
TAMIL NADU |
044439688888
s2r_7@mdrf.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Diabetes Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy participants with normal body mass index |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Reference food |
25/50g available carbohydrates providing glucose will be given on 3 different occasion as test foods will be given to participants for 1 day in morning in fasting state for 2 hours |
| Intervention |
Test Food |
25/50g available carbohydrates providing Barnyard millet puttu mix will be given to participants for 1 day in morning in fasting state for 2 hours |
| Intervention |
Test food |
25/50g available carbohydrates providing high fibre ready to use multigrain roti mix will be given to participants for 1 day in morning in fasting state for 2 hours |
| Intervention |
Test food |
25/50g available carbohydrates providing low glycemic micronutrient enriched kavuni rice analogue will be given to participants for 1 day in morning in fasting state for 2 hours |
| Intervention |
Test food |
25/50g available carbohydrates providing millet and pulse blended functional pasta will be given to participants for 1 day in morning in fasting state for 2 hours |
| Intervention |
Test food |
25/50g available carbohydrates providing Multigrain adai mix will be given to participants for 1 day in morning in fasting state for 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 18.5 to less than 22.9 kg/ m2 (as per WHO cut off for 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, acetylsalicylic acid, thyroxin, vitamins and mineral supplements 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 to treat diabetes and related conditions
pregnant or lactating women
a major medical or surgical event requiring hospitalization within the preceding 3 months;
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 effects on glucose metabolism and body fat distribution).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic index and category of test foods- low glycemic micronutrient enriched kavuni rice analogue, high fibre ready to use multigrain roti mix, barnyard millet puttu mix, Multigrain adai mix, millet and pulse blended functional pasta . |
Each food will be given to the participants on separate occasions in fasting state and capillary blood samples will be collected at fasting (0 min), and post consumption of test and reference food at 15,30,45,60,90 and 120 mins |
|
|
Secondary Outcome
|
|
|
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)
|
09/08/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
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 adults with diabetes 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. |