Effects of the Consumption of Test Product on Urination in Healthy Japanese Adults

NCT07393126 | Recruiting DMC

• 2 other identifiers: 01170-0018-29UMIN000060011
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to test in Japanese adults who experience concerns regarding urinary frequency. The main question it aims to answer is:

• Does consumption of Cranberry Phospholipids reduce daytime urinary frequency? Participants will be given the following tasks:
• Take two tablets daily containing Cranberry Phospholipid for eight weeks.
• Answer the questionnaire on the overactive bladder (OAB)-specific quality of life (QOL).
• Answer the questionnaire on OAB symptoms.
• Answer the questionnaire on urinary frequency during the study period. Researchers will compare Cranberry Phospholipids and placebo groups to see if Cranberry Phospholipids reduces daytime urinary frequency.

Conditions

Healthy Japanese

Keywords

Cranberry; Urination

Outcome Measures

Primary Outcomes (1)

• Measured value for the Overactive Bladder Questionnaire (OAB-q) questionnaire item "frequent urination during the daytime hours" after the 8-week intervention

  Using OAB-q, we evaluate OAB-specific quality of life (QOL). The questionnaire have 33 items, including 8 items measuring "symptom bother" and 25 items measuring "impact on QOL," with each item rated on a 6-point scale."Impact on QOL" is scored across four domains: "Coping" (8 items), "Concern" (7 items), "Sleep" (5 items), and "Social Interaction" (5 items). Scores are calculated on a scale of 0 to 100, with higher scores indicating a greater degree of difficulty. On the other hand, the "impact on QOL" indicates that the higher the score, the better the QOL.

  After the 8-week intervention

Secondary Outcomes (11)

• Individuals whose the response to the OAB-q questionnaire item "frequent urination during the daytime hours" improved by one or more scale points after the 8-week intervention compared to Baseline

  Baseline, and after the 8-week intervention

• The amount of change, and percentage of change from Baseline for the OAB-q questionnaire item "frequent urination during the daytime hours" after the 8-week intervention

  Baseline, after the 1-week intervention, the 3-week intervention and the 8-week intervention

• The measured values, amount of changes, and percentage of changes from Baseline for all other questionnaire items of the OAB-q, excluding "frequent urination during the daytime hours," after the 8-week intervention

  Baseline, after the 1-week intervention, the 3-week intervention and the 8-week intervention

• The measured values, and amount of changes and percentage of changes from Period 1 for the average frequency of urination during the daytime, during the nighttime, and all day, as measured during Periods 2 to 9

  Period 1 (7 days prior to Baseline), Period 2~9 (periods separated by 7 days from the start of intervention)

• Individuals who experienced adverse events

  After the 8-week intervention

Study Arms (2)

Cranberry Phospholipids

ACTIVE COMPARATOR

Take two tablets (containing 120 mg cranberry phospholipids/tablet)

Dietary Supplement: Cranberry Phospholipids

Placebo

PLACEBO COMPARATOR

Take two tablets (containing 0 mg cranberry phospholipids/tablet)

Dietary Supplement: Placebo

Interventions

Cranberry Phospholipids DIETARY_SUPPLEMENT

Take two tablets will be taken once daily

Cranberry Phospholipids

Placebo DIETARY_SUPPLEMENT

Take two tablets will be taken once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthomedico Inc.: collaborator
• Indena Japan Co. LTD: collaborator
• Indena S.p.A: lead

Study Sites (2)

Nerima Medical Association Minami-machi Clinic

Nerima-ku, Tokyo, 176-0002, Japan

RECRUITING

Medical Corporation Seishinkai, Takara Clinic

Shinagawa-Ku, Tokyo, 141-0022, Japan

RECRUITING

Study Officials

• Tsuyoshi Takara, MD

  Medical Corporation Seishinkai, Takara Clinic

  STUDY CHAIR

Central Study Contacts

Naoko Suzuki

CONTACT

+81-3-3818-0610; group_gakujutsu@orthomedico.jp

Asami Baba, PhD

CONTACT

+81-3-3818-0610; asami-baba@orthomedico.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 6, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): June 19, 2026
• Study Completion (Estimated): June 19, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)