Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test beverage: Beverage containing dietary fiber Administration: In principle, dissolve one packet of the powder test food with 180 mL of water and drink it 15 minutes before eac
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 20 or more and less than 65 4. Healthy subjects 5. Subjects who have breakfast, lunch, and dinner every day 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose fasting TG level is less than 400 mg/dL 8. Subjects whose BMI is 18.5 or more and less than 30 at screening (before consumption; Scr) 9. Subjects whose LDL cholesterol is between 120 mg/dL and 139 mg/dL at Scr
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. LDL cholesterol at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed