Healthy Japanese
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose serum uric acid level is between 5.5 mg/dL and 7.0 mg/dL at screening
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, hyperuricemia, gout, alcohol dependency, or drug dependency 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 take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage (particularly contain ingredients that may affect serum uric acid levels such as gallic acid from Terminaria bellirica, luteolin, anserine, Lactobacillus gasseri PA-3, monoglucosyl hesperidin from lemon, phytic acid, ampelopsin, or chitosan) 5. Individuals who are taking or using medications (including herbal medicines, particularly antihyperuricemic, or diuretic) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who drink more than 60 g/day of alcohol at least five days per week 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. 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 10. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of serum uric acid levels at 12 weeks after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of serum uric acid levels at four weeks after intervention and eight weeks after intervention 2. The measured value of serum uric acid levels at four weeks after the end of the intervention | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department