| CTRI Number |
CTRI/2023/04/051815 [Registered on: 20/04/2023] Trial Registered Prospectively |
| Last Modified On: |
19/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Food] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of glycemic index of millet-based foods |
|
Scientific Title of Study
|
Evaluation of glycemic index of multi-millet extruded snack (n=1) |
| Trial Acronym |
Available study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shobana Shanmugam |
| Designation |
Senior Scientist and Head |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetes Food Technology, Madras Diabetes
Research Foundation, Kallam Anji Reddy Centre Plot No 20 Golden
Jubilee Biotech Park for Women Society Sipcot IT Park Siruseri
Chennai
Chennai
TAMIL NADU
603103
India |
| Phone |
91-44-33505555 |
| Fax |
|
| Email |
shobanashanmugam@mdrf.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobana Shanmugam |
| Designation |
Senior Scientist and Head |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetes Food Technology, Madras Diabetes
Research Foundation, Kallam Anji Reddy Centre Plot No 20 Golden
Jubilee Biotech Park for Women Society Sipcot IT Park Siruseri
Chennai
TAMIL NADU
603103
India |
| Phone |
91-44-33505555 |
| Fax |
|
| Email |
shobanashanmugam@mdrf.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shobana Shanmugam |
| Designation |
Senior Scientist and Head |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetes Food Technology, Madras Diabetes
Research Foundation, Kallam Anji Reddy Centre Plot No 20 Golden
Jubilee Biotech Park for Women Society Sipcot IT Park Siruseri
Chennai
TAMIL NADU
603103
India |
| Phone |
91-44-33505555 |
| Fax |
|
| Email |
shobanashanmugam@mdrf.in |
|
|
Source of Monetary or Material Support
|
| Department of Diabetes Food Technology, No.04, Conran Smith road, Gopalapuram, Chennai-600086 |
|
|
Primary Sponsor
|
| Name |
Indian Institute of Millet Research |
| Address |
Rajendra nagar, Hyderabad, Telengana,500030 |
| Type of Sponsor |
Other [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 Shobana Shanmugam |
Madras Diabetes Research Foundation |
Department of Diabetes Food Technology, Madras Diabetes Research Foundation, No.4, Conran Smith Road, Gopalapuram Chennai 600086 Chennai TAMIL NADU
Chennai
TAMIL NADU |
8939688877
shobanashanmugam@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 |
With normal Body Mass Index and with absence
of any known chronic disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Prototype of food product multi-millet extruded snack |
25/ 50 g available carbohydrate providing multi-millet extruded snack 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/250ml
water 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 |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI greater than or equal to 18.5 to less than 22.5 kg/m2
2.No family history of diabetes (first degree) |
|
| ExclusionCriteria |
| Details |
1. A known history of diabetes mellitus or the use of anti-hyperglycaemic drugs or insulin to treat diabetes and related conditions
2. Pregnant or lactating women
3. A major medical or surgical event requiring hospitalization within the preceding 3 months;
4. 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the Glycemic Index of prototype of
developed food product - multi-millet extruded snack |
Standard glucose drink will be given
and capillary blood samples will be performed every
15minutes for the 1 st hour and every 30minutes over
the second hour of testing. This is a total of eight
pricks. Standard glucose drink will be given for 3
different days to get average glucose response and
the test foods will be given on a different occasion
between the 3 reference feeding days to evaluate its
glucose response. |
|
|
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)
|
28/04/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sorghum and millets have been a part of ancient diets, are known for their nutritional values, are
considered as functional foods as they are rich in unique health promoting phytochemicals and they also contain higher levels of quality protein, vitamins and minerals compared to polished white rice
and refined wheat. They survive in arid lands, has a short growing season, farmer friendly and are known for the lower carbon print as compared to rice and wheat. Millets are good sources of
carbohydrates, proteins, fat, fibre, and phytochemicals with nutraceutical potentials. Considering the
high nutritional value, millets are recently renamed as Nutri-cereals by the Government of India through a Gazette Notification. In the above context, millets can serve as nutritious alternatives to rice and wheat and also as ingredients in functional foods. Hence the current proposal focuses on
the following objectives.
1. To develop millet-based value- added product 2. To evaluate the Glycemic Index (GI) of the selected value-added product |