An interventional study of Cranberry Phospholipids and Placebo in Healthy Japanese, sponsored by Indena S.p.A. Recruiting at 2 sites in Japan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Indena S.p.A · Not applicable, Interventional, and Other
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:
Indena S.p.A is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Take two tablets (containing 120 mg cranberry phospholipids/tablet)
Dietary Supplement: Cranberry Phospholipids
Take two tablets (containing 0 mg cranberry phospholipids/tablet)
Dietary Supplement: Placebo
Take two tablets will be taken once daily
Take two tablets will be taken once daily
Measured value for the Overactive Bladder Questionnaire (OAB-q) questionnaire item "frequent urination during the daytime hours" 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.
Time frame: After the 8-week intervention
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: Baseline, and after the 8-week intervention
Body height
Body height is measured using a height meter.
Time frame: Baseline, and after the 8-week intervention
Body weight
Body weight is measured using a body scale.
Time frame: Baseline, and after the 8-week intervention
Blood pressure
Systolic and diastolic blood pressure are measured using a digital wrist-type sphygmomanometer.
Time frame: Baseline, and after the 8-week intervention
Urinalysis
A urine sample (approximately 10 mL) will be collected from each participant, and the samples will be sent to LSI Medience Corporation for analysis.
Time frame: Baseline, and after the 8-week intervention
Peripheral blood examination
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.
Time frame: Baseline, and after the 8-week intervention
Plan to share: No — Data sharing will be discussed among the research affiliates after the study is completed.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Indena S.p.A