A Clinical study to evaluate the glycemic index of 11 rice samples in healthy volunteers

Not Applicable

Completed

• Registration Number: CTRI/2011/10/002035
• Lead Sponsor: Marico Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Volunteers of either sex in the age group between 18 to 45 years.

2. Fasting blood glucose levels < 100mg/dL.

3. Volunteers with body mass index of 18.5 to 22.9.

4. Subjects who provide a written informed consent to abide by the study requirements.

Exclusion Criteria

1. Presence of any chronic disease or illness.

2. Fasting glucose >100 mg%

3. Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.

4. Recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to the study.

5. Volunteers on any regular medication for any given medical illness.

6. Volunteers consuming any medication in the past one week.

7. Participation in any clinical trial within the past 90 days.

8. Receipt of any other prescription drug or over the counter (OTC) drugs within two weeks prior to receiving the first dose of test food or repeated use of drugs within the last four weeks.

9. An unusual diet, special diet, for whatever reason e.g. high protein diet, low sodium diet, for two weeks prior to receiving any test food and throughout subject?s participation in the study.

10. No fasting or feasting a day prior to the test day.

11. Smokers or heavy alcohol consumers

12. Consumption of alcohol / tobacco products within 48 hours prior to dosing / during the study period or difficulty in abstaining from alcohol / tobacco product for the duration of the study.

13. Volunteers with family history of diabetes

14. Volunteers with any history of food allergy

15. Pregnant or lactating females.

16. Presence of HIV 1 and 2 and Hepatitis B and C virus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the glycemic index of test food (11 rice samples)Timepoint: Approximately 35 Days

Secondary Outcome Measures

Name	Time	Method
ilTimepoint: Nil