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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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