Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Aurum Blue(R) Rose Ex M (KRE-101) (100 mg/day) Administration: Consume one capsule with water at any time once daily. *If a dose is missed, it should be consumed
Sponsors
KINJIRUSHI Co., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medicines (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product (particularly, Rosaceae plants such as apples, peaches, or Japanese pears) 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 9. Individuals who are undergoing dietary or exercise therapy under medical supervision 10. Individuals who are unable to abstain from alcohol on the day before the examination 11. Individuals who have a current or past history of drug or alcohol dependence 12. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Individuals who experienced adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed