Healthy JapaneseNCT07393126
Effects of the Consumption of Test Product on Urination in Healthy Japanese Adults
A study testing Cranberry Phospholipids in people with Healthy Japanese, run by Indena S.p.A at 2 sites in Japan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Japanese
- What is being tested?
- Cranberry Phospholipids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesJapan
- Study dates
- 8 Dec 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan2 sites, 2 recruiting
- Recruiting
Nerima Medical Association Minami-machi Clinic
Nerima-ku, Tokyo, 176-0002
Naoko Suzuki, +81-3-3818-0610, group_gakujutsu@orthomedico.jp
Asami Baba, PhD, +81-3-3818-0610, asami-baba@orthomedico.jp
- Recruiting
Medical Corporation Seishinkai, Takara Clinic
Shinagawa-Ku, Tokyo, 141-0022
Naoko Suzuki, +81-3-3818-0610, group_gakujutsu@orthomedico.jp
Asami Baba, PhD, +81-3-3818-0610, asami-baba@orthomedico.jp
About this study
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
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
- Healthy Japanese
- Being tested
- Cranberry Phospholipids, Placebo
- Keywords
- Cranberry, Urination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry PhospholipidsDietary supplement
Take two tablets will be taken once daily
PlaceboDietary supplement
Take two tablets will be taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Cranberry Phospholipids | Active comparator | Take two tablets (containing 120 mg cranberry phospholipids/tablet) Receives: Dietary Supplement: Cranberry Phospholipids |
| Placebo | Placebo comparator | Take two tablets (containing 0 mg cranberry phospholipids/tablet) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After the 8-week intervention
Secondary outcomes (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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, and after the 8-week intervention
Body height
Body height is measured using a height meter.
Measured: Baseline, and after the 8-week intervention
Body weight
Body weight is measured using a body scale.
Measured: Baseline, and after the 8-week intervention
Blood pressure
Systolic and diastolic blood pressure are measured using a digital wrist-type sphygmomanometer.
Measured: 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.
Measured: 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.
Measured: Baseline, and after the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start8 Dec 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy JapaneseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indena S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orthomedico Inc., Indena Japan Co. LTD
- Responsible party
- Sponsor
- Investigators
- Tsuyoshi Takara, MD, Study chair, Medical Corporation Seishinkai, Takara Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393126
- Sponsor's protocol ID
- 01170-0018-29
- Other IDs
- UMIN000060011
- Status last verified
- Sep 2026
- First submitted
- 21 Jan 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be discussed among the research affiliates after the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07393126
- Acronym / sponsor ID
- 01170-0018-29
- Conditions
- Healthy Japanese
- Keywords
- Cranberry, Urination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Indena S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Orthomedico Inc., Indena Japan Co. LTD
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry Phospholipids | Active comparator | Dietary Supplement: Cranberry PhospholipidsTake two tablets (containing 120 mg cranberry phospholipids/tablet) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTake two tablets (containing 0 mg cranberry phospholipids/tablet) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Japanese
- Men or women
- Adults
- Healthy individuals
- Individuals with positive urine leukocytes at baseline
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranberry PhospholipidsTake two tablets will be taken once daily | Dietary supplement | Cranberry Phospholipids |
| PlaceboTake two tablets will be taken once daily | Dietary supplement | Placebo |
Primary outcome
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
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. Data sharing will be discussed among the research affiliates after the study is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tsuyoshi Takara, MD study chair
Medical Corporation Seishinkai, Takara Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry Phospholipids in people with Healthy Japanese, run by Indena S.p.A at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naoko Suzuki (+81-3-3818-0610, group_gakujutsu@orthomedico.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.