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

Indena

Status: Enrolling

Conditions: Healthy Japanese

Treatments: Dietary Supplement: Cranberry Phospholipids; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07393126

01170-0018-29

UMIN000060011 (Registry Identifier)

Details and patient eligibility

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

Cranberry Phospholipids

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Cranberry Phospholipids

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo