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Effects of continuous consumption of the test food on serum uric acid levels

Effects of continuous consumption of the test food on serum uric acid levels: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of continuous consumption of the test food on serum uric acid levels

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058475
Enrollment
80
Registered
2025-07-15
Start date
2025-07-15
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

Healthy Japanese

Interventions

&lt
Duration&gt
Intervention: 12 weeks After the end of the intervention: Four weeks &lt
Anserine-N &lt
Take three tablets per day after breakfast. * If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next da
Placebo &lt

Sponsors

NIHON PHARMACEUTICAL CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose serum uric acid level is between 5.5 mg/dL and 7.0 mg/dL at screening

Exclusion criteria

Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, hyperuricemia, gout, alcohol dependency, or drug dependency 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage (particularly contain ingredients that may affect serum uric acid levels such as gallic acid from Terminaria bellirica, luteolin, anserine, Lactobacillus gasseri PA-3, monoglucosyl hesperidin from lemon, phytic acid, ampelopsin, or chitosan) 5. Individuals who are taking or using medications (including herbal medicines, particularly antihyperuricemic, or diuretic) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who drink more than 60 g/day of alcohol at least five days per week 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 10. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

MeasureTime frame
1. The measured value of serum uric acid levels at 12 weeks after intervention

Secondary

MeasureTime frame
1. The measured value of serum uric acid levels at four weeks after intervention and eight weeks after intervention 2. The measured value of serum uric acid levels at four weeks after the end of the intervention

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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