| CTRI Number |
CTRI/2018/04/013425 [Registered on: 23/04/2018] Trial Registered Prospectively |
| Last Modified On: |
16/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
evaluation of GI of fibre rich white rice |
|
Scientific Title of Study
|
Glycemic index testing of fibre rich white rice varieties |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HEMAMALINI AJ |
| Designation |
PROFESSOR and HEAD |
| Affiliation |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE
PORUR
CHENNAI 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841327708 |
| Fax |
|
| Email |
hemajanardh@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HEMAMALINI AJ |
| Designation |
PROFESSOR and HEAD |
| Affiliation |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE
PORUR
CHENNAI 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841327708 |
| Fax |
|
| Email |
hemajanardh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HEMAMALINI AJ |
| Designation |
PROFESSOR and HEAD |
| Affiliation |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE
PORUR
CHENNAI 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841327708 |
| Fax |
|
| Email |
hemajanardh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MDJ AGRO PVT LTD |
| Address |
TOWER A WING B
1001- 1006
SWASTIK UNIVERSAL
NEAR VALENTINE MULTIPLEX
SURAT
395007
GUJARAT
|
| Type of Sponsor |
Other [FOOD COMPANY] |
|
|
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 |
| HEMAMALINI AJ |
SRI RAMACHANDRA MEDICAL COLLEGE |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE
PORUR
CHENNAI 600116
Chennai
TAMIL NADU |
9841327708
hemajanardh@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SRMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NORMAL HEALTHY BEING |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
HEALTHY VOLUNTEERS
INDIVIDUALS LEADING ACTIVE LIFE WITH NO CO MORBID CONDITION
SUBJECTS WILLING TO PARTICIPATE
NO GENDER BIAS |
|
| ExclusionCriteria |
| Details |
AGE WHO ARE BELOW 18 AND ABOVE 45 YEARS
THOSE WHO ARE ON INSULIN AND WITH OTHER CO MORBID CONDITIONS
SUBJECTS WHO ARE DOING VIGOROUS PHYSICAL ACTIVITY AND SMOKING HABITS
SUBJECTS NOT WILLING TO PARTICIPATE |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of highfibre present in the rice will reduce the glycemic index value. |
every 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HEALTHY VOLUNTEERS CAN EVALUATE THEIR HEALTH STATUS |
HEALTHY VOLUNTEERS CAN EVALUATE THEIR HEALTH STATUS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
25/04/2018 |
| 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="1"
Days="26" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET DONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes therapy is not only about lowering
glucose but also about the overall reduction in the risk factors for diabetic
complications which includes the control of blood pressure and blood lipids This requires lifelong care and management PHASE I SCREENING OF HEALTHY VOLUNTEERS STANDARDISATION OF THE TEST FOOD NUTRIENT EVALUATION PHASE II GLYCEMIC INDEX TEST The
Healthy volunteers will undergo 2 days of testing with the reference food as
per the WHO standards (55 gm of dextrose dissolved in 200ml of water, Glucon
–D) and 2 days with the Test food-I (commonly consumed white rice) followed by wash out period of 2 days and
next two days with Test food -2 ( Plain Payasa Gold rice) followed by a wash out period of 2 days
and next two days with Test food-3( Plain Payasa silver rice) followed by wash
out period of 2 days. Similarly Test food-IV ( Mixed white rice) is given for 2 days , followed by wash out
period of 2 days and next two days with Test food-V ( Mixed rice from Payasa Gold rice ) followed by a wash out period of 2 day and next two days
with Test food-IV (Mixed rice with Payasa Silver rice). Wash out period will minimize the carryover
effects. |