None listed
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese males aged 20-64 years. [2]Subjects who are healthy and have no chronic physical disease. [3]Subjects whose uric acid levels are 6.5 mg/dL-7.9 mg/dL. [4]Subjects whose written informed consent has been obtained after explanation of this study. [5]Subjects who can have an examination on a designated check day. [6]Subjects who are judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Subjects using medicines [2]Subjects having a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia [3]Subjects having a history of disease of liver, kidney, heart, lung, blood [4]Subjects having digestive disease [5]Subjects having hyperuricemia, gout, urinary tract stones, kidney stones, or rheumatoid arthritis [6]Subjects having drugs within 3 month (excludes cases of headaches, colds, etc.) [7]Subjects having allergies to foods and medicines [8]Subjects who fall under any of the following criteria when using a wrist-watch Subjects (1)With photosensitive medication (2)Having epilepsy or sensitivity to flashing lights (3)With poor blood circulation or who bruise easily (4)With tendonitis, carpal tunnel syndrome, or other musculoskeletal disorders (5)Having allergies to rubber or metal (6)With skin diseases [9]Subjects having a habit of exercising at least 3 times a week [10]Subjects having a habit of intense exercise such as marathons or strength training [11]Subjects whose BMI is over 30kg/m2 [12]Subjects who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [13]Subjects who continuously intake of functional foods, health foods, supplements and beverages containing Chinese herbal medicines, Peucedanum japonicum and medicinal herbs [14]Subjects who continuously intake of functional foods, health foods, supplements and beverages that profess the effect for uric acid [15]Heavy drinker (expressed in an amount of alcohol: over 40g/day) [16]Subjects who cannot use application or smartphone for administrating the data of wrist-watch [17]Subjects who cannot always ware wrist-watch [18]Subjects with changing life style [19]Shift worker or night worker [20]Subjects who participated in other clinical studies in the past 3 months [21]Subjects who or whose family works for a company that commodify health and functional foods [22]Subjects who are judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uric acid level (Week 0 , Week 12 and 4 weeks after the end of intake of test food) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1] Quality of life related survey with wrist-watch (Fitbit)(1) [2] Japanese translation of profile of mood states (2) [3] Subjective questionnaire (2) [4] Brief-type self-administered diet history questionnaire (3) *Safety [1] Blood pressure, pulsation (3) [2] Weight, body fat percentage, BMI(3) [3] Hematologic test (3) [4] Blood biochemical test (3) [5] Urine analysis (3) [6] Subject's diary (1) [7] Doctor's questions (3) [8] Adverse events: number of cases and expression rate of adverse events (4) (1): Week 0 to the last day of the test (2): Week 0 and Week 12 (3): Week 0 , Week 12 and 4 weeks after the end of intake of test food (4): Week 12 and 4 weeks after the end of intake of test food | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed