Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058823) titled 'A study to evaluate the effect of the food containing peptides intake on serum uric acid' on Oct. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - HUMA R&D CORP

Condition: Condition - None Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose is to investigate the effect of continuous consumption of the test food for 12 weeks on uric acid levels in Japanese males aged 20 years and older. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Continuous intake of food containing peptides for 12 weeks Interventions/Control_2 - Continuous intake of placebo foods for 12 weeks

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male Key inclusion criteria - 1.Healthy Japanese men aged 20 years or old at the time of obtaining written consent. 2.Subjects with a serum uric acid level between 6.0mg/dL and 7.9mg/dL at SCR. (More than half of the subjects should have a uric acid level between 6.0mg/dL and 7.0mg/dL.) 3.Subjects who have received sufficient explanation of the purpose and content of the research, and have the ability to consent. Key exclusion criteria - 1.Subjects who are currently undergoing medical treatment or have a medical history of hyperuricemia, gout, or urolithiasis. 2.Subjects receiving medication or outpatient treatment for a serious disease. 3.Subjects receiving exercise or diet therapy under the supervision of a physician. 4.Subjects who may develop an allergy to the ingredient of the test food (fish) or aspirin 5.Subjects who have a history of drug dependence or alcohol dependence or have a current medical history. 6.Subjects who have extremely irregular life rhythms due to night work, shift work, etc. 7.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more) or excessive smokers (21 cigarettes/day or more). 8.Subjects who have a history or current illness of serious diseases such as brain disease, malignant tumor, immune disease, kidney disease, liver disorder, cardiovascular disorder, endocrine disorder, or other metabolic disorders. 9.Subjects who use or are unable to stop using health foods, supplements, and drugs that may affect uric acid level. 10.Subjects who are participating in other clinical studies now, or are willing to participate within 3 months prior to the date of obtaining consent. 11.Subjects who has participated in blood collection or donation of more than 200 mL within 1 month or more than 400 mL within 3 months prior to the date of obtaining consent. 12.Subjects who have difficulty complying with recording of each survey form. 13.Subject whose various test results at screening indicate their ineligibility to participate in the study. 14.Subjects who are judged unsuitable for the study by the investigator for other reasons. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 07 Day Date of IRB - 2025 Year 08 Month 08 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2026 Year 03 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067148

Disclaimer: Curated by HT Syndication.