Cranberry phospholipids to reduce daytime urination in healthy Japanese adults
Effects of the Consumption of Test Product on Urination in Healthy Japanese Adults: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Trial
This test will see if taking two cranberry phospholipid tablets daily for eight weeks reduces daytime urination in healthy Japanese adults who feel they urinate too often.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indena S.p.A Industry-sponsored |
| Locations | 2 sites (Nerima-ku, Tokyo and 1 other locations) |
| Trial ID | NCT07393126 on ClinicalTrials.gov |
What this trial studies
Adults who report bothersome daytime urinary frequency will be assigned to receive either cranberry phospholipid tablets or a matching placebo and will take two tablets daily for eight weeks. Participants will complete questionnaires on overactive bladder symptoms (OABSS), OAB-specific quality of life (OAB-q), and urinary frequency during the study period. Researchers will compare changes in daytime urinary frequency between the cranberry phospholipid and placebo groups. The trial enrolls healthy Japanese men and women who meet specific baseline symptom and urine test criteria.
Who should consider this trial
Good fit: Healthy Japanese adults who report high bother from daytime urinary frequency, have relatively low baseline OABSS urgency scores, and have positive urine leukocytes at baseline are the intended candidates.
Not a fit: People with chronic medical conditions, those on treatments for cardiac, hepatic, renal, or metabolic diseases, those with more severe OAB symptoms, or those with implanted cardiac devices are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer a low-risk supplement option to reduce bothersome daytime urinary frequency.
How similar studies have performed: Traditional cranberry extracts have shown mixed results for urinary symptoms and UTI prevention, and cranberry phospholipids are a newer formulation with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Japanese * Men or women * Adults * Healthy individuals * Individuals with positive urine leukocytes at baseline * 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 baseline * Individuals whose "frequent urination during the daytime hours" of "symptom bother" of OAB-q is relatively high at baseline Exclusion Criteria: * Individuals undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction * Individuals carrying a pacemaker or an implantable cardioverter defibrillator * 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 * 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 * Individuals currently regularly taking medications (including herbal medicines) and supplements * Individuals who are allergic to medicines and/or the test-product-related products in this trial * Individuals with urinary pain * 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 * Individuals have overactive bladder symptom (individuals who urinate eight times or more per day, and have urinary urgency at least once a week) * Individuals wake up twice or more to urinate at bedtime * Individuals are pregnant, breast-feeding, and planning to become pregnant * 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 * Individuals are judged as ineligible to participate in the trial by the physician
Where this trial is running
Nerima-ku, Tokyo and 1 other locations
- Nerima Medical Association Minami-machi Clinic — Nerima-ku, Tokyo, Japan (Recruiting)
- Medical Corporation Seishinkai, Takara Clinic — Shinagawa-Ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Naoko Suzuki
- Email: group_gakujutsu@orthomedico.jp
- Phone: +81-3-3818-0610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.