Healthy Japanese adult people
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult people with relatively higher level of blood triglyceride 2. Subjects who are judged as eligible to participate in the study by the principal investigator 3. Among the subjects who met 2nd inclusion criteria, preferentially select subjects whose blood triglyceride level is on the borderline (120 ~ 149 mg/dL), then select subjects whose blood triglyceride level is relatively higher (150 ~ 199 mg/dL). If the number of people who met 2nd inclusion criteria is less than the sample size, select subjects whose blood triglyceride level is relatively higher, however, less than 120 mg/dL.
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional foods/beverages in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products *Particularly, sesame and soybean allergies 6. Subjects who are pregnant, breast-feeding, and planning to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 8. Subjects who are judged as ineligible to participate in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Triglyceride * Assess at screening and examination before consuming and at 4 and 8 weeks after consuming | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total cholesterol 2. High-density lipoprotein (HDL) cholesterol 3. Low-density lipoprotein (LDL) cholesterol * Assess at screening and examination before consuming and at 4 and 8 weeks after consuming | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department