Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Plant extract Loading food: Nucleic acid containing soup Administration: Take one capsule, once a day after breakfast (take one capsule within 20 minutes after taking
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects whose serum uric acid levels are 6.0 mg/dL or more and 7.9 mg/dL or less (among them, more than 22 subjects must be 6.0 mg/dL or more and 7.0 mg/dL or less in their uric acid levels)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects 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. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects who have had symptoms of gout 6. Subjects who work late-night shift and have an erratic lifestyle 7. Subjects who are most likely to eat and drink to excess during the New Year's holiday 8. Subjects who are currently taking medications (including herbal medicines) and supplements 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are pregnant, breast-feeding, or planning to become pregnant 11. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 12. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of the serum uric acid level at 12 weeks after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of the serum uric acid level at four weeks after consumption 2. The amount of changes of the measured values of the serum uric acid level between screening and at four and 12 weeks after consumption 3. The IAUC and Cmax of the serum uric acid level at the start date of the test food consumption (0w) 4. The measured values and changes from before taking the loading food of the serum uric acid level at one, two, three, and four hours after taking the loading food at 0w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed