Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Active tablet Administration: Take one tablet with water three times a day before every meals * Daily dose should be taken within the day. If you forget to take the
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. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who have relatively high LDL cholesterol level in the most recent physical examination 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose LDL cholesterol is between 120 mg/dL and 139 mg/dL at screening (before consumption)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. Subjects who suffer from COVID-19 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 |
|---|---|
| 1. The measured value of LDL cholesterol at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount and rate of change from screening (before consumption; Scr) of LDL cholesterol at four and eight weeks after consumption (4w, 8w) 2. The measured value and the amount and rate of change from Scr of LDL cholesterol at 4w and 8w 3. The measured value and the amount and rate of change from Scr of total cholesterol, HDL cholesterol, and the ratio of LDL cholesterol per HDL cholesterol at 4w, 8w and 12w 4. The rate of subjects whose LDL cholesterol is less than 120 mg/dL at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed