Healthy Japanese subjects
Conditions
Interventions
Duration: eight weeks Test food: CR-033P Dose: Take 2 capsules of the test food per day Administration: Take 1 capsule of the test food with water before 10 to 15 minutes in breakfast and dinner *
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects whose serum ALT are 31 U/L or more and 50 U/L or under.
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects who have a history of the severe liver disorder (viral hepatitis, drug-induced liver injury, cirrhosis) or are currently suspected to have a liver disorder (a positive test result on hepatitis screening, etc.) 3. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 4. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, bladder diseases, or any other chronic diseases 5. Subjects who suffered or have been suffered from diseases related to the biliary tract 6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 7. Currently taking medicines and/or herbal medicines, particularly using anticoagulants such as Warfarin. 8. Subjects who are allergic to medicines and/or the test food related products 9. Subjects who are pregnant, breast-feeding, and planning to become pregnant 10. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 11. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values of serum alanine aminotransferase (ALT) at eight weeks after the start of test-food consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The ratio of number of subjects whose serum ALT at 8w is 30 U/L or under 2. The ratio of number of subjects whose serum ALT before test-food consumption is between 31 U/L or over and 40 U/L or under and whose serum ALT at 8w is 30 U/L or under, and subjects whose serum ALT before test-food consumption is between 41 U/L or over and 50 U/L or under and whose serum ALT at 8w is 40 U/L or under 3. The measured values of serum ALT at four weeks after the start of test-food consumption (4w) 4. The change of serum ALT between before test-food consumption and at 4w and 8w 5-1. The measured values of serum asparate aminotransferase (AST) and gamma-glutamyltranspeptidase (gamma-GT) at 4 and 8 weeks after the start of test-food consumption (4w and 8w) 5-2. The change of serum AST and gamma-GT between before test-food consumption and at 4w and 8w 6-1. The measured values of Visual Analogue Scale (VAS) of fatigue at 2w, 4w, 6w and 8w 6-2. The change of VAS of fatigue between before test-food consumption and at 2w, 4w, 6w and 8w 7-1. The measured values of OSA sleep inventory MA version at 2w, 4w and 8w 7-2. The change of OSA sleep inventory MA version between before test-food consumption and at 2w, 4w and 8w | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed