| CTRI Number |
CTRI/2011/091/000006 [Registered on: 07/01/2011] |
| Last Modified On: |
07/09/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Nutraceutical |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
A Clinical study to evaluate the glycemic index of 4 rice samples in healthy volunteers |
Scientific Title of Study
Modification(s)
|
A prospective, controlled, randomized, study to evaluate the glycemic index of 4 rice samples in healthy volunteers |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| SCR/001/2010 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Viral Shah |
| Designation |
Medical Director |
| Affiliation |
Spectrum Clinical Research Pvt. Ltd. |
| Address |
401, Kshamalaya Building
37, New Marine Lines
Mumbai
MAHARASHTRA
400020
India |
| Phone |
02240645101 |
| Fax |
02266155567 |
| Email |
vshah@spectrumcr.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Viral Shah |
| Designation |
Medical Director |
| Affiliation |
Spectrum Clinical Research Pvt. Ltd. |
| Address |
401, Kshamalaya Building
37, New Marine Lines
Mumbai
MAHARASHTRA
400020
India |
| Phone |
02240645101 |
| Fax |
02266155567 |
| Email |
vshah@spectrumcr.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Viral Shah |
| Designation |
Medical Director |
| Affiliation |
Spectrum Clinical Research Pvt. Ltd. |
| Address |
401, Kshamalaya Building
37, New Marine Lines
Mumbai
MAHARASHTRA
400020
India |
| Phone |
02240645101 |
| Fax |
02266155567 |
| Email |
vshah@spectrumcr.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Marico Ltd.,
Rang Sharda, Krishnachandra Marg, Bandra
Reclamation, Bandra (West),
Mumbai - 400 050, India |
|
Primary Sponsor
Modification(s)
|
| Name |
Marico Ltd |
| Address |
Rang Sharda, Krishnachandra Marg, Bandra Reclamation, Bandra (West), Mumbai - 400 050, India |
| Type of Sponsor |
Other [Consumer Products & Services Group] |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Spectrum Clinical Research Pvt Ltd |
401, Kshamalaya Building, 37 New Marine Lines, Mumbai - 400020 |
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr. Bharat Bhusan |
Artemis Health Institute |
Sector 51,-122001
Gurgaon
HARYANA |
09717211556
0124-6767701
clinicalresearch@artemishealthsciences.com |
| Mr Sree Ganesh |
Seventh Day Adventist Medical Center |
Spencer Road,Frazer Town-560005
Bangalore
KARNATAKA |
09019949599
080-41626643
sreeganeshsg@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE Ethics |
Approved |
| Artemis Health Sciences - IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To find out glycemic index of given rice product |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Glucon D |
50 gm per day |
| Intervention |
Rice |
50 gm per day |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects aged 18-45 years (both
inclusive), healthy (based on medical history),
2. Having BMI 18.5 ? 22.9
3. Fasting blood glucose levels below 100 mg/dl. |
|
| ExclusionCriteria |
| Details |
1. Age below 18 or above 45 years
2. Body mass index below 18.5 or above 22.9 kg/m2 i.e.
should not be obese.
3. Fasting blood glucose above 100 mg/dl
4. Family history of type 2 diabetes i.e. first and second
order should not have diabetes.
5. History of any chronic disease or illness.
6. Any medication consumption in the past one week or
suffering from any illness.
7. Any form of dieting or consumption of a special diet.
8. Smokers and heavy alcohol consumers.
9. Allergy to any food items served.
10. Pregnancy. |
|
Method of Generating Random Sequence
Modification(s)
|
Other |
Method of Concealment
Modification(s)
|
Other |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To evaluate the glycemic index of test food ( 4 rice
samples) |
Approximately 30 Days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
Target Sample Size
Modification(s)
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
11/01/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a prospective, controlled, randomized, study to evaluate the glycemic index of 4 rice samples in healthy volunteers that will be conducted in 2 centre in India. The objective of the study is to evaluate the glycemic index of test food ( 4 rice samples). The study is going to start in 2nd week of January 2011. |