UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058282 |
|---|---|
| Receipt number | R000066628 |
| Scientific Title | Effect of cranberry juice consumption on the urobiome in healthy adults: A randomized, double-Blind, placebo-controlled, crossover trial |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/06/25 23:58:24 |
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Basic information
Public title
Effect of cranberry juice consumption on the urobiome in healthy adults: A randomized, double-Blind, placebo-controlled, crossover trial
Acronym
Effect of cranberry juice consumption on the urobiome in healthy adults
Scientific Title
Effect of cranberry juice consumption on the urobiome in healthy adults: A randomized, double-Blind, placebo-controlled, crossover trial
Scientific Title:Acronym
Effect of cranberry juice consumption on the urobiome in healthy adults
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of continuous cranberry juice consumption on the urinary microbiome (urobiome) in healthy adults.
Basic objectives2
Others
Basic objectives -Others
relative abundance of urobiome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relative abundance of urobiome
Key secondary outcomes
diversity of urobiome
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
80 mL of cranberry juice daily for 4 weeks
Interventions/Control_2
80 mL of placebo juice daily for 4 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Aged 18 years or older at the time of providing informed consent.
Provided written informed consent to participate in the study.
Key exclusion criteria
Use of systemic antibiotics within the 3 months prior to enrollment.
Individuals who are pregnant or breastfeeding.
Individuals deemed unsuitable for the study by the investigator for any reason.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Akagawa |
Organization
Kansai Medical University
Division name
Department of Pediatrics
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata City, Osaka Prefecture, Japan
TEL
0728040101
akagawa.sho@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Akagawa |
Organization
Kansai Medical University
Division name
Department of Pediatrics
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata City, Osaka Prefecture, Japan
TEL
072-804-0101
Homepage URL
akagawa.sho@kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Center, Kansai Medical University
Address
2-5-1 Shinmachi Hirakata Osaka Japan
Tel
0728040101
rinriirb@hirakata.kmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
n/a
Publication of results
Unpublished
Result
URL related to results and publications
n/a
Number of participants that the trial has enrolled
43
Results
Baseline urobiomes differed between sexes (p=0.015). Overall alpha and beta diversity were unchanged by either intervention. However, cranberry juice induced a sex-specific change: the relative abundance of Lactobacillus significantly decreased in women (p=0.025), an effect not seen with placebo. No significant compositional changes occurred in men.
Results date posted
| 2025 | Year | 06 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 43 recruited participants, 40 (19 men and 21 women) completed the study. Three participants were excluded from the final analysis due to antibiotic use during the study period. Adherence was high, with a median intake compliance rate of 100%; no participants had a compliance rate below 80%. The median age of the participants who completed the study was 38 years , and the median body mass index (BMI) was 22.2.
Participant flow
The study protocol began with a 4-week observational period, during which no cranberry products were administered. Following this, participants were randomly assigned to either the cranberry-first or placebo-first arm. In the first intervention period, participants consumed 80 mL of either cranberry juice or placebo juice daily for four weeks. The first intervention was followed by a 4-week washout period. Afterwards, participants crossed over to the opposite intervention arm for the final 4-week period. Urine samples were collected a total of four times during the 16-week study
Adverse events
none
Outcome measures
At baseline, the urobiome composition differed significantly between men and women (PERMANOVA, p = 0.015). Overall alpha and beta diversity did not change significantly in either sex after either intervention. However, a compositional change was observed in women: cranberry juice consumption led to a significant decrease in the relative abundance of Lactobacillus (median: 28.4% to 18.4%; p = 0.025), an effect not seen with placebo. No significant compositional changes were observed in men after either intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066628
