Effects of the Consumption of Test Product on 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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Japanese
• Intervention / Treatment: Dietary supplement: Cranberry Phospholipids; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naoko Suzuki; Phone Number: +81-3-3818-0610; Email: group_gakujutsu@orthomedico.jp
• Study Contact Backup: Name: Asami Baba, PhD; Phone Number: +81-3-3818-0610; Email: asami-baba@orthomedico.jp

Study Locations

• Japan
  • Tokyo
    • Nerima-ku, Tokyo, Japan, 176-0002
      • Recruiting
      • Nerima Medical Association Minami-machi Clinic
      • Contact: Naoko Suzuki; Phone Number: +81-3-3818-0610; Email: group_gakujutsu@orthomedico.jp
      • Contact: Asami Baba, PhD; Phone Number: +81-3-3818-0610; Email: asami-baba@orthomedico.jp
      • Principal Investigator: Masafumi Nagata, MD
    • Shinagawa-Ku, Tokyo, Japan, 141-0022
      • Recruiting
      • Medical Corporation Seishinkai, Takara Clinic
      • Contact: Naoko Suzuki; Phone Number: +81-3-3818-0610; Email: group_gakujutsu@orthomedico.jp
      • Contact: Asami Baba, PhD; Phone Number: +81-3-3818-0610; Email: asami-baba@orthomedico.jp
      • Principal Investigator: Tsuyoshi Takara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cranberry Phospholipids; Take two tablets (containing 120 mg cranberry phospholipids/tablet)	Dietary supplement: Cranberry Phospholipids; Take two tablets will be taken once daily
Placebo Comparator: Placebo; Take two tablets (containing 0 mg cranberry phospholipids/tablet)	Dietary supplement: Placebo; Take two tablets will be taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Using OAB-q, we evaluate OAB-specific 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.	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	Using OAB-q, we evaluate OAB-specific 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.	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	Using OAB-q, we evaluate OAB-specific 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.	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	Participants will maintain a daily diary of their urination frequency during two distinct periods: for 7 days immediately preceding the Baseline, and from the beginning of the intervention until the day before the final examination.	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	During the trial period, if a participant exhibits any clinically significant "new manifestation of abnormality" or "aggravation" in his/her physical signs and symptoms, it is considered to be an adverse event.	After the 8-week intervention
Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Baseline	The ratio of cases which had test items stated in urinalysis and peripheral blood examination within their respective standard ranges before intervention but exceeded the ranges after intervention are calculated, intergroup comparison at each time point is performed using tests for comparing proportions.	Baseline, and after the 8-week intervention
Body height	Body height is measured using a height meter.	Baseline, and after the 8-week intervention
Body weight	Body weight is measured using a body scale.	Baseline, and after the 8-week intervention
Blood pressure	Systolic and diastolic blood pressure are measured using a digital wrist-type sphygmomanometer.	Baseline, and after the 8-week intervention
Urinalysis	A urine sample (approximately 10 mL) will be collected from each participant, and the samples will be sent to LSI Medience Corporation for analysis.	Baseline, and after the 8-week intervention
Peripheral blood examination	A venous blood sample (approximately 10 mL) will be collected from each participant, and the samples will be sent to LSI Medience Corporation for analysis.	Baseline, and after the 8-week intervention

Collaborators and Investigators

• Sponsor: Indena S.p.A
• Collaborators: Orthomedico Inc.; Indena Japan Co. LTD
• Investigators: Study Chair: Tsuyoshi Takara, MD, Medical Corporation Seishinkai, Takara Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): June 19, 2026
• Study Completion (Estimated): June 19, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cranberry; Urination
• Other Study ID Numbers: 01170-0018-29; UMIN000060011 (Registry Identifier: UMIN-CTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will be discussed among the research affiliates after the study is completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No