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A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level.

A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level. - A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024579
Enrollment
9
Registered
2016-10-31
Start date
2016-10-31
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

At the first term(Day1), subjects take test food 1. After 6-days of washout, at the second term(Day8), subjects take either (1)test food 2 or (2)placebo. After 6-days of washout, at the third term(Day
-Monophosphate Disodium Salt with cold or hot water 10 mins after intake of capsules. At the first term(Day1), subjects take test food 2. After 6-days of washout, at the second term(Day8), subjects
-Monophosphate Disodium Salt with cold or hot water 10 mins after intake of capsules. At the first term(Day1), subjects take placebo. After 6-days of washout, at the second term(Day8), subjects take e
-Monophosphate Disodium Salt with cold or hot water 10 mins after intake of capsules.

Sponsors

Suntory Global Innovation Center Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1)Healthy male subjects aged 20 years old or more. (2)Subjects with serum uric acid level more than or equal to 7.1 mg/dL, and less than 9.0 mg/dL. (3)Subjects who can visit hospital on the designated day. (4)Subjects who agree with the given description and express written informed consent.

Exclusion criteria

Exclusion criteria: (1)Subjects with symptom of gouty arthritis or gouty node. (2)Subjects with serum uric acid level more than or equal to 8.0 mg/dL, who are suffered from complications such as kidney damage, urinary stone, hypertension, ischemic cardiac disease, and diabetes. (3)Subjects with UUA/UCr less than or equal to 0.40, where UUA and UCr stand for urinary uric acid and urinary creatinine level, respectively. (4)Subjects whose systolic blood pressure is less than 90mmHg. (5)Subjects who donated more than 200 mL of blood and/or blood components within the past four weeks prior to the current study. (6)Subjects who donated more than 400 mL of blood within the last three months prior to the current study. (7)Subjects whose accumulated amount of donated blood would excess 1200 mL over the past 12 months, if the amount of blood sampling in the current study is added. (8)Subjects who are participating in other clinical studies, or who finished the clinical study within the last four weeks. (9)Subjects with disease on heart, liver, or kidney. (10)Subjects with a previous history of disease on circulatory organs. (11)Subjects diagnosed with diabetes. (12)Subjects who have allergic reaction to drug medicine and food. (13)Subjects who drink alcohol a lot and smoke a lot. (14)Subjects who have an irregular eating pattern. (15)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results. (16)Subjects who have tested positive for infectious disease (17)Subjects who have difficulty in swallowing. (18)Subjects who are judged as unsuitable for the current study by the principal investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Efficacy : Area under the curve of serum uric acid level. Safety : Incidence of adverse effects

Countries

Japan

Contacts

Public ContactShinya Fukizawa

Suntory Global Innovation Center Ltd. Innovation Development Department

Shinya_Fukizawa@suntory.co.jp050-3182-0595

Outcome results

None listed

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