Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing plant-derived ingredients Administration: Take 4 tablets, once per day at any time during the day.
Duration: 12 weeks Test food: Placebo tablets
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects 2. Japanese adult subjects 3. Subjects who are determined as eligible to participate in the study by the physician 4. Subjects who are between >=6.1 mg/dL and <7.0 mg/dL, or >=7.0 mg/dL and <=7.9 mg/dL in serum uric acid level
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 diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hyperuricemia, obesity (based on the standard definition by the Japan Society for the Study of Obesity), or any other chronic diseases 4. Subjects who have had symptoms of gout 5. Subjects who work late-night shift or are irregular of their life-styles 6. Subjects who excessively exercise 7. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional foods/beverages in daily 8. Subjects who are currently taking medications (including herbal medicines) and supplement. Particularly, diosmin, anticoagulant drugs, antiplatelet drugs, antihypertensive drugs (celiprolol hydrochloride, diltiazem hydrochloride, and etc.), diazepam, central nervous system depressant, and vasodilator drugs (verapamil) 9. Subjects who are an allergic reaction to medications and/or products that contain the study ingredients, particularly citrus. 10. Subjects who are pregnant, lactation, or planning to become pregnant 11. Subjects who have been enrolled in another clinical study within the last three months prior to signing informed consent for the current study or plan to enroll in anther clinical study during study period 12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum uric acid level *Measure the level at screening (before consumption) and 4, 8, and 12 weeks after consumption and calculate the amount of change. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Urinary uric acid level 2. Urinary creatinine level 3. Urinary uric acid/urinary creatinine ratio 4. Subjective symptoms (the Likert scale) *1-4Measure the values and levels at screening (before consumption) and 4, 8, and 12 weeks after consumption and calculate the amount of change. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed