None listed
Conditions
Interventions
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy males and females aged 20 to 64 years old. (2)Subjects whose AST and ALT are up to 50 U/L, and gamma-GT are up to 100 U/L in the screening test. (3)Subjects whose BMI are less than 30. (4)Subjects who are judged not suffering from a disease by the investigator. (5)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: (1)Subjects who regularly use medications. (2)Subjects who contract or are under treatment for serious diseases (e.g., liver disease, cardiovascular disease, respiratory disease, endocrine disease and/or metabolic disease). (3)Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (4)Subjects who have a history of and/or contract drug addiction and/or alcoholism. (5)Subjects who have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent or habit of drinking not less than 5 days a week. (6)Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during test periods. (7) Subjects who can't stop drinking from 2 days before each measurement. (8) Subjects who have declared allergic reaction to ingredients of test foods. (9) Subjects who are shiftworker and/or midnight-shift worker. (10)Subjects with extremely irregular dietary habits. (11)Subjects who plan to travel abroad, including overseas travel, during test periods. (12)Subjects who have been pregnant or have a plan to become pregnant, or breast feed during the study period. (13)Subjects who have donated over 200 mL of blood and/or blood components within the last 4 weeks prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (14)Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (15)Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT,AST | — |
Secondary
| Measure | Time frame |
|---|---|
| gamma-GT, Questionnaire survey | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed