Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07393126

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

Led by Indena S.p.A · Updated on 2026-02-06

76

Participants Needed

2

Research Sites

27 weeks

Total Duration

On this page

Sponsors

I

Indena S.p.A

Lead Sponsor

O

Orthomedico Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Japanese
  • Men or women
  • Adults
  • Healthy individuals
  • Individuals with positive urine leukocytes at baseline
  • Individuals with urinary urgency score less than two or total overactive bladder symptom score less than three at baseline
  • Individuals with relatively high "frequent urination during the daytime hours" symptom bother score at baseline
Not Eligible

You will not qualify if you...

  • Individuals undergoing medical treatment or with history of malignant tumor, heart failure, or myocardial infarction
  • Individuals with pacemaker or implantable cardioverter defibrillator
  • Individuals treated for cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, or other chronic diseases
  • Individuals using "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional foods/beverages daily
  • Individuals regularly taking medications (including herbal medicines) and supplements
  • Individuals allergic to medicines or test-product-related products
  • Individuals with urinary pain
  • Individuals undergoing or requiring treatment for urinary-related diseases such as benign prostatic hypertrophy, prostatitis, prostate cancer, overactive bladder, hypoactive bladder, cystitis, interstitial cystitis, bladder cancer, bladder stones, urethritis, urethral stricture, neurological disease, polyuria, nocturnal polyuria
  • Individuals with overactive bladder symptoms (urinating eight or more times per day and urinary urgency at least once a week)
  • Individuals waking two or more times to urinate at bedtime
  • Pregnant, breastfeeding, or planning pregnancy
  • Individuals enrolled in other clinical trials within 28 days before or during this trial
  • Individuals judged ineligible by the physician

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Nerima Medical Association Minami-machi Clinic

Nerima-ku, Tokyo, Japan, 176-0002

Actively Recruiting

2

Medical Corporation Seishinkai, Takara Clinic

Shinagawa-Ku, Tokyo, Japan, 141-0022

Actively Recruiting

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Research Team

N

Naoko Suzuki

CONTACT

A

Asami Baba, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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