Healthy Japanese subjects
Conditions
Interventions
Duration: 24 weeks Test food: Supplements containing the plant-derived ingredient (the plant-derived ingredient 10 mg/capsule) Administration: Take six capsules per day at after breakfast with appr
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 45 or more and less than 65 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose serum ALT are 31U/L or more and 50U/L or under at Scr 7. Subjects whose serum AST are 50U/L or under at Scr 8. Subjects whose serum gamma-GT are 100U/L or under at Scr
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 pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hepatitis B, hepatitis C, or any other chronic diseases 4. Subjects who have a habit of drinking an average of 60 g or more of pure alcohol per day on a weekly 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. Subjects who currently taking medications (including herbal medicines) and supplements 7. Subjects allergic to medications and/or the test-food-related products. Particularly allergic to shrimp, crab, egg, wheat, soba (buckwheat), peanut, and milk 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. 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 24 weeks after the start of test-food consumption (24w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of serum ALT at four and 12 weeks after the start of test-food consumption (4w and 12w) 2. The change of serum ALT from screening (Scr) to after intervention (Scr to four weeks after the start of test-food consumption [4w], Scr to 12w, and Scr to 24w) 3. The change of serum ALT from before consumption (0w) to after intervention (Scr to 4w, Scr to 12w, and Scr to 24w) 4. The measured values of serum asparate aminotransferase (AST), gamma-glutamyltranspeptidase (GT) and glutathione at 4w, 12w and 24w 5. The change of serum AST, gamma-GT and glutathione from Scr to after intervention (Scr to 4w, Scr to 12w, and Scr to 24w) 6. The change of serum AST, gamma-GT and glutathione from 0w to after intervention (Scr to 4w, Scr to 12w, and Scr to 24w) 7. The ratio of number of subjects whose serum ALT at Scr is between 31 U/L or over and 40 U/L or under and whose serum ALT at 24w is 30 U/L or under, and subjects whose serum ALT at Scr is between 41 U/L or over and 50 U/L or under and whose serum ALT at 24w is 40 U/L or under | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed