None
Conditions
Interventions
Continuous intake of food containing peptides for 12 weeks
Continuous intake of placebo foods for 12 weeks
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Healthy Japanese men aged 20 years or old at the time of obtaining written consent. 2.Subjects with a serum uric acid level between 6.0mg/dL and 7.9mg/dL at SCR. (More than half of the subjects should have a uric acid level between 6.0mg/dL and 7.0mg/dL.) 3.Subjects who have received sufficient explanation of the purpose and content of the research, and have the ability to consent.
Exclusion criteria
Exclusion criteria: 1.Subjects who are currently undergoing medical treatment or have a medical history of hyperuricemia, gout, or urolithiasis. 2.Subjects receiving medication or outpatient treatment for a serious disease. 3.Subjects receiving exercise or diet therapy under the supervision of a physician. 4.Subjects who may develop an allergy to the ingredient of the test food (fish) or aspirin 5.Subjects who have a history of drug dependence or alcohol dependence or have a current medical history. 6.Subjects who have extremely irregular life rhythms due to night work, shift work, etc. 7.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more) or excessive smokers (21 cigarettes/day or more). 8.Subjects who have a history or current illness of serious diseases such as brain disease, malignant tumor, immune disease, kidney disease, liver disorder, cardiovascular disorder, endocrine disorder, or other metabolic disorders. 9.Subjects who use or are unable to stop using health foods, supplements, and drugs that may affect uric acid level. 10.Subjects who are participating in other clinical studies now, or are willing to participate within 3 months prior to the date of obtaining consent. 11.Subjects who has participated in blood collection or donation of more than 200 mL within 1 month or more than 400 mL within 3 months prior to the date of obtaining consent. 12.Subjects who have difficulty complying with recording of each survey form. 13.Subject whose various test results at screening indicate their ineligibility to participate in the study. 14.Subjects who are judged unsuitable for the study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum uric acid | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miyazawa
HUMA R&D CORP Clinical Development Department
Outcome results
None listed