| CTRI Number |
CTRI/2012/03/002492 [Registered on: 14/03/2012] Trial Registered Retrospectively |
| Last Modified On: |
26/07/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate the glycemic index of test (food)
products: Rice 1, Rice 2, Rice 3 and Rice 4 in controlled type 2 diabetic patients. |
|
Scientific Title of Study
|
A prospective, comparative study to evaluate the glycemic index of test (food)
products: Rice 1, Rice 2, Rice 3 and Rice 4 in controlled type 2 diabetic patients. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SCR/002/2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Haridas Upadya |
| Designation |
Principal Investigator |
| Affiliation |
Aadithya Adhikari Hospital |
| Address |
Contour Road, Gokulam
Mysore
KARNATAKA
570002
India |
| Phone |
08214190291 |
| Fax |
08214190291 |
| Email |
dr.upadya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Bharani Bhaskar |
| Designation |
Project Manager |
| Affiliation |
Spectrum Clinical Research Pvt. Ltd. |
| Address |
401 - Kshamalaya Building
37, New Marine Lines
Mumbai
MAHARASHTRA
400020
India |
| Phone |
02240645100 |
| Fax |
02266155567 |
| Email |
bbhaskar@spectrumcr.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Bharani Bhaskar |
| Designation |
Project Manager |
| Affiliation |
Spectrum Clinical Research Pvt. Ltd. |
| Address |
401 - Kshamalaya Building
37, New Marine Lines
Mumbai
MAHARASHTRA
400020
India |
| Phone |
02240645100 |
| Fax |
02266155567 |
| Email |
bbhaskar@spectrumcr.com |
|
|
Source of Monetary or Material Support
|
| Marico Ltd., Rang Sharda, Krishnachandra Marg, Bandra Reclamation, Bandra (West), Mumbai - 400 050, India |
|
|
Primary Sponsor
|
| 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
|
| Name |
Address |
| Spectrum Clinical Research Pvt Ltd |
401, Kshamalaya Building, 37 New Marine Lines, Mumbai - 400020 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devaraju |
Aadithya Adhikari Hospital |
Department of Medicine,
Contour Road,Gokulam, Mysore
Mysore
KARNATAKA |
09902100668
08214190291
dr.devarajucj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mysore Clinical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
55.5g of glucose powder [glucose monohydrate equivalent to 50g of available carbohydrate] |
Route of administration of comparator agent is oral. During visits 2, 5, 8, 55.5gm of glucose powder will be dissolved in 200 ml of water to be consumed within 10 minutes from the first bite. |
| Intervention |
Rice |
Route of administration of intervention is oral. During visits 3, 4, 6, 7, 9, 10, 11, 12, 13, 14, & 15, 50 gm rice sample per serving will be cooked in electric cooker and given to the volunteers to be consumed with 200 ml of water within 10 minutes from the first bite. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed to be suffering from Type 2 diabetes mellitus taking oral hypoglycemic drugs or insulin and with blood sugar stabilized within normal range(Fasting sugar level < 110 mg/dl &
Postprandial sugar level < 140 mg/dl )
2. Patients of either sex in the age group between 30 to 60 years.
3. Patients confirmed to be in normal health status by performing the below mentioned investigations
A) clinical examination B) Haematological investigations: Hemoglobin, Complete blood count & Erythrocyte sedimentation rate C) Biochemical investigations: Alanine transaminase, aspartate
transaminase, serum proteins, Albumin globulin ratio, serum bilirubin,fasting blood glucose, postprandial blood glucose level, blood urea
nitrogen and serum creatinine D) X-ray chest E) Electrocardiogram
F)Urine pregnancy test for female patients G) HIV 1, 2 & HBsAg testing
All the above mentioned investigations must be normal (parameters tested in all investigations must be in the normal range ± 5% as reflected in the reports)
4. Patient with body mass index of >18.5kg/m 2 and < 25 kg/m2 [1]
5. Patient with HbA1C < 7%
6. Subjects who provide a written informed consent to abide by the study requirements. |
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed as Type 1 diabetes mellitus 2.Presence of any clinically significant abnormal results of investigations done at screening e.g. significant abnormality of Liver Function Test
(more than 2.5 times upper limit of normal), & Renal Function Test (more than 1.5 times upper limit of normal),fasting glucose >110 mg% , postprandial blood sugar level > 140 mg%
3.Patients in the last one month with
A) any major illness requiring hospitalization
B) acute exacerbation of any ongoing chronic medical illness e.g.Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc. Medications requiring change of doses for treatment of the
chronic illness
2. Patients suffering from severe cardiac, renal, liver or any other organ impairment.
3. History of seizures, epilepsy or anyneurological disorders.
4. Consumption of alcohol / tobacco products within 48 hours prior to dosing of test /reference product and during the study period (17 days to 33 days )
5. Use of any recreational drug or a history of drug addiction.
6. Participation in any clinical trial within the past 90 days.
7. Receipt of any other prescription drug or over the counter (OTC) drugs for more than 24 hours within two weeks prior to receiving the first dose of test or food product
8. An unusual diet, special diet, e.g. high protein diet, low sodium diet, for two weeks prior to receiving any test food product and
throughout subject’s participation in the study.
9. Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study.
10. Patient with any history of food allergy
11. Pregnant or lactating females |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the glycemic index of test food ( 4 rice
samples) |
Approximately 35 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/02/2012 |
| 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
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective, comparative study to evaluate the glycemic index of test (food) products: Rice 1, Rice 2, Rice 3 and Rice 4 in controlled type 2 diabetic patients that will be conducted in one centre in India. The objective of the study is to evaluate the glycemic index of test food ( 04 rice samples).
Selected patients will be asked to come to the trial site after 10-12 hours of overnight fast. Each patient will receive the reference food on three occasions and each rice sample on eleven occasions on separate days in a random order. Each patient will serve as his or her own control.
Capillary blood samples will be collected and blood glucose readings would be noted down as per the glucometer at ten different time points i.e. -5mins , 0mins (will be averaged to obtain Fasting Blood glucose reading), 15mins, 30mins, 45mins, 60mins, 90mins, 120mins, 150mins & 180mins during each visit for 35 days of study period.
Blood glucose level will be used to determine glycemic index.
Subject completes all his/her visit within 35 days & after completing the final visit glycemic index will be assessed.
Blood sample will be taken for testing blood glucose level. |