Tokyo, Jan. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060447) titled 'A Study for the Effect of Food Containing Plant Extract on Improvement of Quality of Life Related to Urinary Function. -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-' on Jan. 23.

Study Type: Interventional

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

Primary Sponsor: Institute - KSO Corporation

Condition: Condition - No Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To confirm the effect of food containing plant extract on improvement of Quality of Life Related to Urinary Function. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Food Containing Plant Extract, 8 weeks consumption. Interventions/Control_2 - Placebo Products, 8 weeks consumption.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1)Healthy Japanese males and females aged 20 to 79 years-old. 2)Subjects whose BMI are under 30. 3)Subjects who tend to feel frequent urination. 4)Subjects who are not suspected of having overactive bladder in the OABSS score, and/or having benign prostatic hyperplasia in the IPSS score at screening. 5)Subjects who can make self-judgment and are voluntarily giving written informed consent. Key exclusion criteria - Subjects(who) 1)are currently undergoing or have been deemed to require treatment for urinary disorders, and/or taking or have taken medication related to urinary function. 2)have a history of and/or contract serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease). 3)contract sleep apnea syndrome. 4)are under treatment for or have a history of drug addiction and/or alcoholism. 5)have a history and/or a surgical history of digestive disease affecting digestion and absorption. 6)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during study periods. 7)have declared allergic reaction to foods. 8)can't stop drinking from 2 days before each measurement. 9)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week. 10)are shiftworker and/or midnight-shift worker. 11)live with people requiring long-term care. 12) sleep with a spouse, children, or pets and do not sleep alone in the same bed. 13)are judged as unsuitable for the current study by the investigator based on clinical testing during screening. 14)have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. 15)are pregnant or planning to become pregnant or breastfeed during the study period. 16)are participating in or willing to participate in other clinical studies. 17)are judged as unsuitable for the current study by the investigator for other reasons. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 26 Day Anticipated trial start date - 2026 Year 02 Month 03 Day Last follow-up date - 2026 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069142

Disclaimer: Curated by HT Syndication.