| CTRI Number |
CTRI/2020/11/029208 [Registered on: 18/11/2020] Trial Registered Prospectively |
| Last Modified On: |
18/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Food processing] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Glycemic index testing of health food products suitable for elderly with diabetes |
|
Scientific Title of Study
|
Evaluation of glycemic index of developed health food products suitable for elderly with diabetes
|
| 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 - Foods Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of FNDR
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 - Foods Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of FNDR
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 |
Mrs Sudha Vasudevan |
| Designation |
Senior Scientist, Head - Department of Foods Nutrition and Dietetics Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4, Conran Smith Road,
Gopalapuram,
Chennai - 600 086,
Fax : 91-44-28350935
Chennai
TAMIL NADU
603103
India |
| Phone |
91-44-43968888 |
| Fax |
|
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| Department of Foods Nutrition and Dietetics Research, Madras Diabetes Research Foundation, 4, Conran Smith Road, Gopalapuram, Chennai-600086 |
|
|
Primary Sponsor
|
| Name |
Department of Science Technology |
| Address |
SEED Division, Department of Science & Technology New Mehrauli Road, New Delhi-110 016 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Ms Sudha Vasudevan |
Department of Foods Nutrition and Dietetics Research |
Madras Diabetes Research Foundation, 4, Conran Smith Road
Gopalapuram, Chennai - 600086
Chennai
TAMIL NADU |
914443968888
s2r_7@mdrf.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 |
The age group of 25-50 yrs with normal BMI (18.5-22.9 kg/m2) and having no family history of diabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Commercial control products |
5 commercial control products (5 samples for GI determinations). |
| Intervention |
Prototype of food products |
One time session for each food sample of prototype of 5 newly developed food products -Idly mix, Multigrain porridge mix, Breakfast cereal, Snack, Beverage mix (15 samples for GI determination) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Normal BMI (18.5-22.9 kg/m2)
No family history of diabetes
|
|
| ExclusionCriteria |
| Details |
1.Self-report of any condition/illness that may affect the study outcomes or would make participation potentially harmful, including severe kidney disease, cardiovascular disease (coronary artery disease, peripheral vascular disease), history of stroke, cancer, severe psychological disorders (schizophrenia, dementia), or hypothyroidism, as ascertained by a detailed medical history.
2.Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Glycemic Index of prototype of 5 developed food products -Idly mix, Multigrain porridge mix, Breakfast cereal, Snack, Beverage mix |
1 year |
|
|
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)
|
26/12/2020 |
| 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="1"
Months="0"
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
|
Age is an independent risk factor for non-communicable diseases such as diabetes and cardiovascular diseases. According to the census 2011 there are nearly 104 million elderly person in India. The ageing population faces numerous challenges like difficulty in food consumption (swallowing), dentures, physical inactivity, isolation from the family, financial constraints etc. There are plenty of health foods available in market for general population but specific food for elderly population with diabetes especially convenience foods such as the product mentioned in proposal are almost nil. Due to physical inability many depend on home cooked meals and many a times lack of hygiene seems to be an issue. Hence, it is very important to develop convenience foods which are easy to prepare and appropriate for old aged people with lower glycemic properties to suit the needs of elderly with diabetes |