Tokyo, July 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058475) titled 'Effects of continuous consumption of the test food on serum uric acid levels' on July 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - NIHON PHARMACEUTICAL CO., LTD.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of continuous consumption of the test food on serum uric acid levels Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention: 12 weeks After the end of the intervention: Four weeks

Anserine-N

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 day. Interventions/Control_2 - Intervention: 12 weeks After the end of the intervention: Four weeks

Placebo

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 day.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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 Key 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 Target Size - 80

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 06 Month 25 Day Date of IRB - 2025 Year 06 Month 25 Day Anticipated trial start date - 2025 Year 07 Month 15 Day Last follow-up date - 2026 Year 03 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066856

Disclaimer: Curated by HT Syndication.