NCT07393126招募中不适用
Effects of the Consumption of Test Product on Urination in Healthy Japanese Adults: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Trial
Indena S.p.A2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年12月8日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Measured value for the Overactive Bladder Questionnaire (OAB-q) questionnaire item "frequent urination during the daytime hours" after the 8-week intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women
- •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
排除标准
- •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
研究组 & 干预措施
Cranberry Phospholipids
Active Comparator
Take two tablets (containing 120 mg cranberry phospholipids/tablet)
干预措施: Cranberry Phospholipids (Dietary Supplement)
Placebo
Placebo Comparator
Take two tablets (containing 0 mg cranberry phospholipids/tablet)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Measured value for the Overactive Bladder Questionnaire (OAB-q) questionnaire item "frequent urination during the daytime hours" after the 8-week intervention
时间窗: 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.
次要结局
- 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(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(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(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(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(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(Baseline, and after the 8-week intervention)
- Body height(Baseline, and after the 8-week intervention)
- Body weight(Baseline, and after the 8-week intervention)
- Blood pressure(Baseline, and after the 8-week intervention)
- Urinalysis(Baseline, and after the 8-week intervention)
- Peripheral blood examination(Baseline, and after the 8-week intervention)
研究者
研究点 (2)
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