Effect of Intake of a Food Containing Peucedanum japonicum Root Extract on Uric Acid Levels.
- Conditions
- o
- Registration Number
- JPRN-UMIN000048431
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 40
Not provided
[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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ric acid level (Week 0 , Week 12 and 4 weeks after the end of intake of test food)
- Secondary Outcome Measures
Name Time Method *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