None listed
Conditions
Interventions
Subjects take control food for 4 weeks. Before and after repeated intake, subjects take Oral Glucose Tolerance Test to measure blood glucose levels.
Subjects take test food 1 (containing botanical in
Sponsors
Suntory Global Innovation Center Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male and female subjects whose ages are 20 <= years old <65. (2) Subjects who can visit the specified clinic on the scheduled day. (3) Subjects who agree with the given description and express informed consent via telecommunication and written documents. (4) Subjects whose blood glucose levels during the 75g OGTT are as follows; A. equivalent to or higher than 157 mg/dl at 30 min. B. equivalent to or higher than 130 mg/dl at 120 min., or whose Matsuda-index is lower than 4.3.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of blood glucose levels after Oral Glucose Tolerance Test Incidence of adverse effects | — |
Countries
Japan
Contacts
Public ContactShinya Fukizawa
Suntory Global Innovation Center Ltd. Research Institute
Outcome results
None listed