A verification study for the effect of the food containing plant-derived ingredients intake on uric acid level: a randomized, double-blind, placebo-controlled, parallel-group trial

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000035298
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-09-14
• Study Start: 2019-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hyperuricemia, obesity (based on the standard definition by the Japan Society for the Study of Obesity), or any other chronic diseases 4. Subjects who have had symptoms of gout 5. Subjects who work late-night shift or are irregular of their life-styles 6. Subjects who excessively exercise 7. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional foods/beverages in daily 8. Subjects who are currently taking medications (including herbal medicines) and supplement. Particularly, diosmin, anticoagulant drugs, antiplatelet drugs, antihypertensive drugs (celiprolol hydrochloride, diltiazem hydrochloride, and etc.), diazepam, central nervous system depressant, and vasodilator drugs (verapamil) 9. Subjects who are an allergic reaction to medications and/or products that contain the study ingredients, particularly citrus. 10. Subjects who are pregnant, lactation, or planning to become pregnant 11. Subjects who have been enrolled in another clinical study within the last three months prior to signing informed consent for the current study or plan to enroll in anther clinical study during study period 12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified