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A Dose Finding Study on the Effect of Food Containing Plant Extract on Serum Uric Acid -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

A Dose Finding Study on the Effect of Food Containing Plant Extract on Serum Uric Acid -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- - A Dose Finding Study on the Effect of Food Containing Plant Extract on Serum Uric Acid

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036766
Enrollment
60
Registered
2019-05-17
Start date
2019-05-18
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

No (subjects whose serum uric acid levels are 5.9 mg/dL to 7.9 mg/dL)

Interventions

Food containing medium-dose plant extract, 8 weeks consumption Food containing high-dose plant extract, 8 weeks consumption Food not containing plant extract, 8 weeks consumption

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. 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: (1) Subjects who 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. (2) Subjects who have a history of and/or hyperuricemia and/or gout attack. (3) Subjects who 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. (4) Subjects who have meals less than twice a day. (5) Subjects who can't stop drinking from 2 days before each measurement. (6) Subjects who have declared allergic reaction to ingredients of test foods. (7) Subjects who 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). (8) Subjects who contract chronic disease and are under treatment. (9) Subjects who have abnormality in renal function. (10) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (11) Subjects who are judged as unsuitable for the current study by the investigator through the screening tests. (12) Subjects who 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. (13) Subjects who have a history of and/or contract drug addiction and/or alcoholism. (14) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Serum uric acid

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

yoshi@kso.co.jp03-3452-7733

Outcome results

None listed

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