A study evaluating the effect of botanical ingredient-containing food on glucose tolerance.
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000044161
- Lead Sponsor
- Suntory Global Innovation Center Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 135
Not provided
(1) Systolic pressure <90 mmHg (2) Subjects who are pregnant or lactating. (3) Subjects who donated over 200ml blood components or whole blood within the past 4 weeks prior to the current study. (4) Male who donated over 400ml whole blood within the past 12 weeks. (5) Female who donated over 400ml whole blood within the past 16 weeks. (6) Male whose blood was collected more than 1200 mL within the last 12 months when the amount of blood sampling in the current study is added. (7) Female whose blood was collected over 800 mL within the last 12 months when the amount of blood sampling in the current study is added. (8) Subjects who are participating in other clinical studies, or who finished clinical study within the last 4 weeks. (9)Subjects a) with disease on heart, liver, kidney or other organs complications. b) with a previous history of disease on circulatory organs. c) who are contracting diabetes. d) with test food allergy. e) whose fasting blood glucose is equivalent to or higher than 140 mg/dL by a finger stick blood test. (10) Subjects who have severe allergic reaction to drug medicine and food. (11) Subjects with a previous history of feeling sick after blood sampling. (12) Subjects who have difficulty in blood sampling from peripheral vein. (13) Subjects who drink over 60 g of alcohol per day on average. (14) Subjects who have irregular eating patterns. (15) Subjects who work irregular shifts or at midnight. (16) Subjects whose BMI is less than 18.5 or over 30.0 kg/m2. (17) Subjects who are constantly taking certain drug medicine, or who are expecting taking it within the period of current study, or who have indispensable supplements, functional foods affecting the test results. (18) Subjects who are contracting atopic dermatitis and/or allergy symptoms. (19) Subjects who are contracting alcohol hypersensitivity. (20) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve of blood glucose levels after Oral Glucose Tolerance Test Incidence of adverse effects
- Secondary Outcome Measures
Name Time Method