A study to evaluate effect of consumption of two white rice varieties on Blood glucose in healthy human volunteers
- Registration Number
- CTRI/2017/06/008837
- Lead Sponsor
- ITC Life Sciences and Technology Center ITC LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the effect of two white rice varieties on glycaemic indexTimepoint: Screening and each visit
- Secondary Outcome Measures
Name Time Method To determine the iAUC of two white rice varietiesTimepoint: Screening and each visit