Tokyo, July 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059414) titled 'Study on the Effects of Test Food Intake on Urinary Discomfort in Women' on July 16.

Study Type: Interventional

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

Primary Sponsor: Institute - User Life Science Co.,Ltd.

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

Objective: Narrative objectives1 - To examine the effects of test food intake on urinary discomfort in women Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will consume the test food for 24 weeks They will take one packet per day with water or lukewarm water Interventions/Control_2 - Participants will consume the placebo for 24 weeks They will take one packet per day with water or lukewarm water

Eligibility: Age-lower limit - 18 years-old

Gender - Female Key inclusion criteria - (1) Individuals who are generally considered to be healthy (2) Women who subjectively experience mild urinary discomfort (e.g., pain during urination, cloudy urine, or residual urine sensation) several times a year (3) Individuals who can give voluntary written consent to participate in the present trial Key exclusion criteria - (1) Individuals who regularly consume any dietary supplements, quasi-drugs, or medicines that have the same or similar effects as those evaluated in this study (2) Individuals who have changed or newly started taking health foods or dietary supplements within the past 4 weeks (3) Individuals who work night shifts or rotating shifts (4) Individuals receiving medical or preventive treatment (e.g., hormone replacement, pharmacotherapy, exercise, or dietary therapy) at the time of obtaining informed consent, or judged to require such treatment (5) Individuals with a history of serious metabolic, hepatic, renal, cardiovascular, respiratory, endocrine, immune, neurological, or psychiatric disorders. (6) Individuals with a medical history of alcohol or drug dependence (7) Individuals who might develop an allergic reaction to foods (8) Individuals who are pregnant, breastfeeding, or intend to become pregnant during the study period (9) Individuals who have participated in any other human study involving foods, medicines, quasi-drugs, or medical devices within the past 4 weeks, or who plan to participate in another study during the study period (10) Individuals who are judged by the investigator to be unsuitable for participation in the study Target Size - 40

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 09 Month 01 Day Date of IRB - 2025 Year 02 Month 27 Day Anticipated trial start date - 2025 Year 10 Month 02 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067951

Disclaimer: Curated by HT Syndication.