Healthy volunteers
Conditions
Interventions
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese males and females aged 20 years or older but under 65 at the time of consent. (2) Individuals who have had a health examination within the past year, with ALT (GPT) levels between 31 U/L and 50 U/L, and whose other blood test results show no abnormalities requiring treatment. (3) Individuals who have received sufficient explanation about the study and signed the informed consent form prior to participation.
Exclusion criteria
Exclusion criteria: (1) Individuals currently undergoing treatment for, or with a history of, malignant tumors, heart failure, or myocardial infarction. (2) Individuals currently receiving treatment for, or with a history of, any of the following conditions: [1] Arrhythmia, renal impairment, cerebrovascular disease, thyroid disorders, gastrointestinal diseases, rheumatoid arthritis, diabetes, dyslipidemia, hypertension, or other chronic illnesses. [2] Liver diseases (including hepatitis, fatty liver, cirrhosis, liver cancer) (3) Individuals currently undergoing treatment for, or with a history of, drug or alcohol dependence. (4) Individuals with mental disorders or depressive symptoms or currently receiving treatment for such conditions. (5) Individuals with food allergies or those who may be allergic to the test food. (6) Individuals who regularly use prescription drugs or quasi-drugs that may affect the study outcomes and are unable to discontinue their intake during the study period. (7) Individuals who regularly consume health foods that may affect the study outcomes and are unable to discontinue their use during the study period. (8) Individuals who consume excessive amounts of alcohol. (9) Individuals with a heavy smoking habit. (10) Individuals unable to abstain from alcohol and smoking from the day before each visit until the end of the examination. (11) Individuals who may be unable to maintain their usual lifestyle. (12) Individuals with extremely irregular lifestyle habits, such as night shift workers. (13) Individuals planning to travel abroad during the study period. (14) Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period. (15) Individuals who participated in another clinical trial within one month prior to the date of consent, or plan to participate in another clinical trial during the study period. (16) Individuals deemed inappropriate for participation by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function tests (AST (GOT), ALT (GPT), gamma-GT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Likert-Type Scale | — |
Countries
Japan
Contacts
Public ContactMasako Mizuuchi
APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.
Outcome results
None listed