Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing fish oil Administration: Take three capsules per day at any time during the day. * If you forget to take the test food, take it as soon as you rem
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects whose LDL cholesterol level was high in the most recent health checks 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects whose LDL cholesterol levels are 120 mg/dL or more and 139 mg/dL or less at screening
Exclusion criteria
Exclusion criteria: 1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake 5. Subjects regularly taking medications (including herbal medicines) and supplements 6. Subjects allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, lactating, or intending to become pregnant 8. 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 9. 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 the start of test-food consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of LDL cholesterol at four and eight weeks after the start of test-food consumption 2. The amount of changes of LDL cholesterol between before and four, eight and 12 weeks after the start of test-food consumption 3. The rate of changes of LDL cholesterol between before and four, eight and 12 weeks after the start of test-food consumption 4. The ratio of number of subjects whose LDL cholesterol levels are less than 120 mg/dL at 12 weeks after the start of test-food consumption 5-1. The measured values of the following items 5-2. The amount of changes of the following items [Items] total cholesterol, HDL cholesterol, flow mediated dilation (FMD), maximum expansion width of vessel, diameter of vessels at rest, blood flow velocity, visibility of vessels, density of vessels, diameter of vessels, distance between vessels and length of vessels 6. The ratio of number of subjects whose blood vessels are straight and shaped like hairpins, twisted and various shapes, irregular such as branches, or look short (hard to see) after four, eight and 12 weeks after the start of test-food consumption 7. The measured values of each item of original questionnaires at four, eight and 12 weeks after the start of test-food consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed