None listed
Conditions
Interventions
Subjects take control food for 12 weeks. Before and after repeated intake, subjects take blood sampling.
Subjects take test food 1 (containing botanical ingredient) for 12 weeks. Before and after repe
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 written documents. (4) Subjects whose HbA1c is equal to or more than 5.6 % and less than 6.5 %.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | — |
Countries
Japan
Contacts
Public ContactShinya Fukizawa
Suntory Global Innovation Center Ltd. Research Institute
Outcome results
None listed