A Study on the Effect of Plant Extract on Postprandial Serum Uric Acid -A Randomized, Double-blind, Placebo-controlled, Cross-over Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000043527
- Lead Sponsor
- KSO Corporation
- Brief Summary
Statistically significant difference was confirmed in the primary outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 60
Not provided
Subjects (who) (1) are judged hyperuricemia in need of treatment and are under treatment. (2) whose serum creatinine levels are 1.3 mg/dL or over by the screening tests. (3) have a history of and/or contract serious diseases (eg, liver and kidney disease, digestive disease, heart disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). (4) contract chronic disease and are under treatment. (5) are judged as unsuitable for the current study by the investigator through the screening tests. (6) have a history and/or a surgical history of digestive disease affecting digestion and absorption. (7) whose BMI are 30 or more. (8) declared allergic reactions to foods. (9) can't stop using medicines, quasi-drugs, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting serum uric acid during test periods. (10) have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent or a habit of drinking not less than 5 days a week. (11) can't stop drinking and intense exercise from 2 days before each measurement. (12) can't stop ingestion of meals other than designated meals from a day before each measurement. (13) have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (14) have a history of and/or contract drug addiction and/or alcoholism. (15) are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (16) are judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum uric acid and change in uric acid
- Secondary Outcome Measures
Name Time Method