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NCT Number: NCT07393126

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

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nerima Medical Association Minami-machi Clinic, Nerima-ku, Tokyo, Japan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cranberry Phospholipids

Dietary Supplement

Take two tablets will be taken once daily

Placebo

Dietary Supplement

Take two tablets will be taken once daily

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

    Time frame: 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.

Secondary outcomes

  1. 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

    Time frame: Baseline, and 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.

  2. 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

    Time frame: Baseline, after the 1-week intervention, the 3-week intervention and 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.

  3. 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

    Time frame: Baseline, after the 1-week intervention, the 3-week intervention and 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.

  4. 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

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

    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.

  5. Individuals who experienced adverse events

    Time frame: After the 8-week intervention

    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.

  6. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Baseline

    Time frame: Baseline, and after the 8-week intervention

    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.

  7. Body height

    Time frame: Baseline, and after the 8-week intervention

    Body height is measured using a height meter.

  8. Body weight

    Time frame: Baseline, and after the 8-week intervention

    Body weight is measured using a body scale.

  9. Blood pressure

    Time frame: Baseline, and after the 8-week intervention

    Systolic and diastolic blood pressure are measured using a digital wrist-type sphygmomanometer.

  10. Urinalysis

    Time frame: Baseline, and after the 8-week intervention

    A urine sample (approximately 10 mL) will be collected from each participant, and the samples will be sent to LSI Medience Corporation for analysis.

  11. Peripheral blood examination

    Time frame: Baseline, and after the 8-week intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Asami Baba, PhD

CONTACT

[email protected]

+81-3-3818-0610

Naoko Suzuki

CONTACT

[email protected]

+81-3-3818-0610

Sponsors and collaborators

Lead sponsor

Indena S.p.A

Industry

Collaborators

  • Indena Japan Co. LTD
  • Orthomedico Inc.

Registry information

Official study title

Effects of the Consumption of Test Product on Urination in Healthy Japanese Adults: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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