Healthy male adults and hyperuricemia
Conditions
Interventions
Ingestion of high-dose test supplement for 4 consecutive weeks
Ingestion of middle-dose test supplement for 4 consecutive weeks
Ingestion of low-dose test supplement for 4 consecutive weeks
Ingestion
Sponsors
TTC Co.,Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Subjects aged from 20 to 65 years old 2. Subjects whose serum uric acid levels are included within a range of 6.0 mg/dL to 8.0 mg/dL.
Exclusion criteria
Exclusion criteria: 1. Subjects who usually take some medicine, foods for specified health uses, foods with function claims, health foods, or cosmetics including active ingredients 2. Subjects who have been taking foods affecting the study results once a week or more 3. Subjects who have gout in the past or are currently receiving treatment for hyperuricemia or gout (including exercise therapy, dietary guidance) 4. Subjects who are under treatment or have history of diseases (urinary stone, kidney stone, rheumatoid arthritis) which may influence the outcome of the study 5. Subjects who routinely use analgesics (non-steroidal analgesics, steroidal analgesics, etc.). 6.Subjects who habitually do intense exercise such as marathon 7. Subjects who cannot carry out the procedures of various inspections to be carried out during the research as specified. 8. Subjects who have diseases requiring continuous medication, or serious medical history who needed medication therapy 9. Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) 10. Subjects with allergies to the test food in the study 11. Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 12. Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 13. Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire 14. Subjects who are judged as unsuitable for the study by the investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum uric acid | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary uric acid (creatinine adjusted), Fractional excretion of uric acid Subgroup analysis using serum uric acid levels and other clinical measurements | — |
Countries
Japan
Contacts
Public ContactHiroyasu Shimada
TTC Co.,Ltd. Clinical Research Planning Department
Outcome results
None listed