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A Study on the Effect of Plant Extract on Postprandial Serum Uric Acid -A Randomized, Double-blind, Placebo-controlled, Cross-over Study-

A Study on the Effect of Plant Extract on Postprandial Serum Uric Acid -A Randomized, Double-blind, Placebo-controlled, Cross-over Study- - A Study on the Effect of Plant Extract on Postprandial Serum Uric Acid

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043527
Enrollment
60
Registered
2021-03-05
Start date
2021-03-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1) Males aged 20 to 64 years-old. (2) Subjects whose serum uric acid levels are 5.9 mg/dL to 7.9 mg/dL by the screening tests, however, more than half of all subjects have a serum uric acid level of 7.0 mg/dL or less. (3) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Serum uric acid and change in uric acid

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026