| CTRI Number |
CTRI/2022/10/046860 [Registered on: 27/10/2022] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Foods] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Glycemic Index testing of millet based food products. |
|
Scientific Title of Study
|
Evaluation of glycemic index of millet-based value-added food products
(n:5) |
| Trial Acronym |
|
|
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
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
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 |
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 |
8939688877
shobanashanmugam@mdrf.in |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Prototype of food product millet biscuit |
One time session for prototype millet biscuit (15 samples for GI determination) |
| Intervention |
Prototype of food product millet muesli |
One time session for prototype millet muesli (15 samples for GI determination) |
| Intervention |
Prototype of food product millet pasta |
One time session for prototype millet pasta (15 samples for GI determination) |
| Intervention |
Prototype of food product millet pilaf |
One time session for prototype millet pilaf (15 samples for GI determination) |
| Intervention |
Prototype of food product porridge mix |
One time session for prototype Porridge mix (15 samples for
GI determination) |
|
|
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 5
developed food products -Porridge mix, Millet pilaf, Flakes based food products, millet pasta and biscuits
|
Capillary blood glucose will be assessed at -5, 0 (fasting)15,30,45,60,90,120 mins post ingestion of test
and reference foods. The testing will be done on separate days for 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)
|
01/11/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 products. 2. To evaluate the Glycemic Index (GI) of five of selected value-added products. |