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

Official title

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

Overview

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.

Interventions

• Dietary supplement Cranberry Phospholipids
  Take two tablets will be taken once daily
• Dietary supplement Placebo
  Take two tablets will be taken once daily

Primary outcome measures

• 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]

Secondary outcome measures (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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline, and after the 8-week intervention]
• Body height [Time frame: Baseline, and after the 8-week intervention]
• Body weight [Time frame: Baseline, and after the 8-week intervention]
• Blood pressure [Time frame: Baseline, and after the 8-week intervention]
• Urinalysis [Time frame: Baseline, and after the 8-week intervention]
• Peripheral blood examination [Time frame: Baseline, and after the 8-week intervention]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Other

Study locations

Japan · 2 centers

• Nerima Medical Association Minami-machi Clinic — Nerima-ku
• Medical Corporation Seishinkai, Takara Clinic — Shinagawa-Ku

Identifiers

NCT: NCT07393126 · 01170-0018-29 · UMIN000060011

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗