| CTRI Number |
CTRI/2017/06/008837 [Registered on: 15/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to evaluate effect of consumption of two white rice varieties on Blood glucose in healthy human volunteers |
|
Scientific Title of Study
|
A study to evaluate effect of consumption of two white rice varieties on Glycaemic Index in healthy human volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SCPL-01-17 Version 2.0 dated 12.May.2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudha Raj |
| Designation |
Head Clinical Operation |
| Affiliation |
Sapthagiri Clintrac pvt ltd |
| Address |
Sapthagiri Clintrac Pvt ltd
No15 Chikkasandra
Hesarghtta main road
Bangalore
Bangalore KARNATAKA 560090 India |
| Phone |
9900073260 |
| Fax |
|
| Email |
sudha.raj@sapthagiriclintrac.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yashwanth Radhakrishnan |
| Designation |
Lead Scientist |
| Affiliation |
ITC Life Sciences and Technology Center, ITC LTD, |
| Address |
ITC Life Sciences and Technology Center, ITC LTD,
Peenya Industrial Area, 1st Phase, Bangalore .
Bangalore KARNATAKA 560058 India |
| Phone |
9964358455 |
| Fax |
|
| Email |
Yashwanth.Radhakrishnan@itc.in |
|
Details of Contact Person Public Query
|
| Name |
Sudha Raj |
| Designation |
Head Clinical Operation |
| Affiliation |
Sapthagiri Clintrac pvt ltd |
| Address |
Sapthagiri Clintrac Pvt ltd
No15 Chikkasandra
Hesarghtta main road
Bangalore #15,chikkasandra,Hesaragatta Main road,Bangalore Bangalore KARNATAKA 560 090 India |
| Phone |
9900073260 |
| Fax |
|
| Email |
sudha.raj@sapthagiriclintrac.com |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences and Technology Center
No. 3, 1st Main, 1st Phase, Peenya Industrial Area,
Peenya, Bangalore – 560058
|
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences and Technology Center ITC LTD |
| Address |
ITC Life Sciences and Technology Center, ITC LTD,
Peenya Industrial Area, 1st Phase, Bangalore 560058.
|
| Type of Sponsor |
Other [FMCG] |
|
|
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 |
| Dr Bindumathi P L |
Sapthagiri Institute of Medical Sciences & Research Center. |
#15,Chikkasandra,Hesaragatta Main Road,
Bangalore-560 090
Bangalore KARNATAKA |
08028393392
drbinduraghu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri institute of medical science and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with normal Health with out Diabetes mellitus. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2 white Rice varieties |
Total 68-69 gm of uncooked weight of the test sample will be consumed orally along with 200 ml of drinking water after 10-12 hours of overnight fasting. Each rice varieties will be served twice during the study periods followed by reference in between each test arm. |
| Comparator Agent |
Dextrose (glucose monohydrate) |
Fifty-five grams of dextrose (glucose monohydrate) dissolved in 200 ml water will be used as the reference food. The reference food will be consumed (after 10-12 hours of overnight fasting) at the beginning, middle and end of the two varieties of rice. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy adults (based on medical history and screening tests) age between 18 and 45 years male and female (1:1 ratio) will be enrolled into the study after written informed consent has been obtained.
2.Subject is willing to give written, signed and dated informed consent to participate in the study before initiating any study related procedure.
3.Fasting blood glucose levels less than 100 mg/dl
4.BMI should be between 18.5 to 25 kg/m2
5.Lipid profile (Triglycerides, Cholesterol, LDL, HDL, VLDL) within normal range as applicable to each parameter.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with BMI less than 18.5kg/m2 or more than 25kg/m2 will be excluded from the study.
2.Fasting blood glucose levels > 100mg/dl.
3.Subjects with Clinically significant Lipid profile values are excluded
4.Subjects particularly on any special diet
5.Subjects suffering with diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases or severe food allergies; an active infectious disease (HBV, HCV,HIV); a current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders
6.Pregnant or lactating women
7.Subject having participated in any other clinical trial within one month prior to screening
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of two white rice varieties on glycaemic index |
Screening and each visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the iAUC of two white rice varieties |
Screening and each visit |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/05/2017 |
| Date of Study Completion (India) |
17/07/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published in any journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A study to evaluate effect of consumption of two white rice varieties on Glycaemic Index in healthy human volunteers- The study duration for each subject would be up to 20 days. There is a possible screening period of up to 7 days and a treatment period of 13 days. After obtaining Informed consent, subjects will be screened for inclusion and exclusion criteria, clinical and demographic data, Physical examination, collection of anthropometric measurements, vital Signs, lab investigations (Hematology, Biochemistry, Lipid profile, Glucose, Blood Insulin and Urine analysis), UPT will be performed for female subjects before and after the study. Once all the eligibility criteria are met, participant will be enrolled to the study. Subjects will be housed at least 10-12 hr prior to dosing till 4 hr after dosing on each visit. The night meal will be served to the participants as per the Institutional standards at least 10-12hrs before the test/reference dose served as per treatment chart. Diet will be served under the supervision of delegated study team member to the subjects. Subjects will be evaluated for well-being and checked out from the facility. Concomitant medication and adverse events will be reported on each visit days during study conduct including check in and checkout days. The study end points includes-Primary endpoint Such as Measurement of Blood glucose levels at all time points including pre-dose samples. Secondary endpoint includes measurement of serum Insulin levels on all dosing days. |