A verification study of the reduction effect of LDL cholesterol
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000047717
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 56
Not provided
Subjects 1. who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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. who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. currently taking medicines (include herbal medicines) and supplements 6. who are allergic to medications and/or the test-beverage-related products 7. who have a surgical history of either gastrointestinal disease influencing digestion and absorption or digestive organ, or current history of disorder such as stricture in digestive organ 8. who tend to have diarrhea or constipation on daily 9. who have a pre-existing or present condition of drug or alcohol dependence 10. whose daily average number of smoking cigarettes is 21 or more 11. whose daily average amount of drinking as pure alcohol is over 60 g 12. who are shift workers or late-night shift workers 13. who are pregnant, lactation, or planning to become pregnant 14. who suffer from COVID-19 15. who cannot prepare the test beverages according to pre-decided instructions and take them three times when eating each diet a day 16. who are collected blood or donated blood components either 200 mL within 28 days or over 400 mL within three months before the agreement to participate in this trial 17. 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 18. who are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. LDL cholesterol at 12 weeks after consumption (12w)
- Secondary Outcome Measures
Name Time Method 1. LDL cholesterol at four and eight weeks after consumption (4w, 8w) 2. The ratio of subjects within each group whose LDL cholesterol is less than 120 mg/dL at 12w 3. Total cholesterol, non HDL cholesterol, HDL cholesterol, the ratio of LDL cholesterol per HDL cholesterol, and triglyceride (TG)