A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000048040
- 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) pregnant or lactating. (3) donated over 200ml blood components or whole blood within the past 4 weeks. (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 more than 800 mL within the last 12 months when the amount of blood sampling in the current study is added. (8) 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) contracting diabetes. d) with test food allergy. (10) Who have possibility to be diagnosed as diabetes; whose fasting blood glucose is equal to or more than 126 mg/dL, or whose blood glucose level during the 75g OGTT is equivalent to or more than 200 mg/dL at 120 min., or whose HbA1c is equal to or more than 6.5 %. (11) with severe allergic reaction to drug medicine and food. (12) with a previous history of feeling sick after blood sampling. (13) Who have difficulty in blood sampling from peripheral vein. (14) Who drink alcohol a lot (over 60 g of alcohol per day on average). (15) Who have irregular eating patterns. (16) Who work irregular shifts or at midnight. (17) constantly taking certain drug medicine, or expecting taking it within the period of current study, or indispensable supplements, functional foods (including Food for Specified Health Uses) affecting the test results. (18) whose BMI is less than 18.5 or equal to or more than 30.0 kg/m2. (19) contracting atopic dermatitis and/or allergy symptoms. (20) contracting alcohol hypersensitivity. (21) 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
- Secondary Outcome Measures
Name Time Method