| CTRI Number |
CTRI/2022/03/041340 [Registered on: 24/03/2022] Trial Registered Prospectively |
| Last Modified On: |
23/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Glycemic Index of Rice varieties |
|
Scientific Title of Study
|
National Mission Mode Program on Nutritional improvement of digestible protein content and quality in rice |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Ananthan |
| Designation |
Scientist E |
| Affiliation |
ICMR National Institute of Nutrition |
| Address |
Food Chemistry Division
ICMR National Institute of Nutrition
JamaiOsmania PO
Hyderabad
Hyderabad
TELANGANA
500007
India |
| Phone |
9866373363 |
| Fax |
|
| Email |
ananthan.nin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R Ananthan |
| Designation |
Scientist E |
| Affiliation |
ICMR National Institute of Nutrition |
| Address |
Food Chemistry Division
ICMR National Institute of Nutrition
JamaiOsmania PO
Hyderabad
Hyderabad
TELANGANA
500007
India |
| Phone |
9866373363 |
| Fax |
|
| Email |
ananthan.nin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Ananthan |
| Designation |
Scientist E |
| Affiliation |
ICMR National Institute of Nutrition |
| Address |
Food Chemistry Division
ICMR National Institute of Nutrition
JamaiOsmania PO
Hyderabad
Hyderabad
TELANGANA
500007
India |
| Phone |
9866373363 |
| Fax |
|
| Email |
ananthan.nin@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1. ICAR-Indian Institute of Rice Research, Rajendernagar, Hyderabad-500030, Telangna
2. National Institute of Plant Genome Research, New Delhi-110012.
3. National Rice Research Institute, Cuttack, Odisha-753006 |
|
|
Primary Sponsor
|
| Name |
DBT |
| Address |
Govt of India |
| 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 |
| Ananthan R |
National Institute of Nutrition |
II Floor, Old laboratory, Food Chemistry Division
Jamai Osmania
Hyderabad
TELANGANA |
09866373363
ananthan.nin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal BMI aged between 20 to 40 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bamboo rice |
Its seeds of bamboo, commonly consumed by the indigenous people of Southern Western Ghats. 200 gram of cooked bamboo rice will be eaten by each subject only once. The time of first bite in the mouth will be set as time 0 and capillary blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes post ingestion of the test foods for checking the glucose level. |
| Intervention |
DRRDhan 48 |
Rice variety developed by Indian Institute of Rice Research (ICAR-IIRR). 200 gram of cooked rice will be eaten by each subject only once. The time of first bite in the mouth will be set as time 0 and capillary blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes post ingestion of the test foods for checking the glucose level. |
| Intervention |
DRRDhan 53 |
Rice variety developed by Indian Institute of Rice Research (ICAR-IIRR). 200 gram of cooked rice will be eaten by each subject only once. The time of first bite in the mouth will be set as time 0 and capillary blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes post ingestion of the test foods for checking the glucose level. |
| Intervention |
DRRDhan 58 |
Rice variety developed by Indian Institute of Rice Research (ICAR-IIRR). 200 gram of cooked rice will be eaten by each subject only once. The time of first bite in the mouth will be set as time 0 and capillary blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes post ingestion of the test foods for checking the glucose level. |
| Intervention |
DRRDhan 60 |
Rice variety developed by Indian Institute of Rice Research (ICAR-IIRR). 200 gram of cooked rice will be eaten by each subject only once. The time of first bite in the mouth will be set as time 0 and capillary blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes post ingestion of the test foods for checking the glucose level. |
| Intervention |
DRRDhan 62 |
Rice variety developed by Indian Institute of Rice Research (ICAR-IIRR). 200 gram of cooked rice will be eaten by each subject only once. The time of first bite in the mouth will be set as time 0 and capillary blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes post ingestion of the test foods for checking the glucose level. |
| Intervention |
Pearl millet |
Cooked pearl millet food. Around 200 gram of cooked pearl millet food will be eaten by each subject only once. The time of first bite in the mouth will be set as time 0 and capillary blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes post ingestion of the test foods for checking the glucose level. |
| Intervention |
Samba Mahsuri |
Rice variety developed by Indian Institute of Rice Research (ICAR-IIRR). 200 gram of cooked rice will be eaten by each subject only once. The time of first bite in the mouth will be set as time 0 and capillary blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes post ingestion of the test foods for checking the glucose level. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Healthy males.
Non-pregnant and non-lactating females.
21 to 40 years of age.
Fasting blood (FB) sugar levels <110 mg/dL.
BMI 18.5 to 22.9 kg/m2.
|
|
| ExclusionCriteria |
| Details |
<18 or >40 years of age.
FB glucose value of >110 mg/dL.
Having a known history of impaired glucose tolerance or DM. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood sugar level in all the volunteers which will be used to compute the Glycemic Index of the samples. |
One day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Glycemic Index of rice and other millets samples.
Determination of Glycemic load of the foods. |
One day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/03/2022 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The current GI study will be conducted using well-established method recommended by WHO/FAO. There are 30 healthy adult volunteers (both male and female) will be recruited for this study. All participants will undergo 4 days of testing with the reference food (50 g glucose) and then 1 day with the test foods. On each test day, the volunteers will visit the GI testing Centre in the morning after a 10-12 hr overnight fast. |