Tokyo, Dec. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060011) titled 'Effects of the consumption of test product on urination in healthy Japanese adults' on Dec. 8.

Study Type: Interventional

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

Primary Sponsor: Institute - Indena S.p.A. Medical Department at Product Portfolio Office

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

Objective: Narrative objectives1 - To investigate the effects of test product consuming on urination in healthy adults. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Eight weeks Test product: Tablet containing 120 mg cranberry phospholipids Administration: Two tablets/day Interventions/Control_2 - Duration: Eight weeks Test product: Placebo Administration: Two tablets/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 with positive urine leukocytes at Scr

6. Individuals whose score of urinary urgency of overactive bladder symptom score (OABSS) is less than two or total score of OABSS is less than three at Scr

7. Individuals whose "frequent urination during the daytime hours" of "symptom bother" of OAB-q is relatively high at Scr Key exclusion criteria - 1. Individuals undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals carrying a pacemaker or an implantable cardioverter defibrillator

3. Individuals undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily diet

5. Individuals currently regularly taking medications (including herbal medicines) and supplements

6. Individuals who are allergic to medicines and/or the test-product-related products in this trial

7. Individuals with urinary pain

8. Individuals undergoing treatment, have had treatment within two months, or need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, prostatitis, prostate cancer, overactive bladder, hypoactive bladder, cystitis, interstitial cystitis, bladder cancer, bladder stones, urethritis, urethral stricture, neurological disease, polyuria, and nocturnal polyuria

9. Individuals have overactive bladder symptom (individuals who urinate eight times or more per day, and have urinary urgency at least once a week)

10. Individuals wake up twice or more to urinate at bedtime

11. Individuals are pregnant, breast-feeding, and planning to become pregnant

12. Individuals have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

13. Individuals are judged as ineligible to participate in the trial by the physician Target Size - 70

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 07 Day Date of IRB - 2025 Year 11 Month 07 Day Anticipated trial start date - 2025 Year 12 Month 08 Day Last follow-up date - 2026 Year 06 Month 19 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068635

Disclaimer: Curated by HT Syndication.