UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061052 |
|---|---|
| Receipt number | R000069858 |
| Scientific Title | Elucidating the Effects of Vegetable Intake on Intestinal Bile Acid Metabolism to Establish Primary Prevention Strategies for Colorectal Cancer |
| Date of disclosure of the study information | 2026/03/25 |
| Last modified on | 2026/03/25 15:16:29 |
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Basic information
Public title
Elucidating the Effects of Vegetable Intake on Intestinal Bile Acid Metabolism to Establish Primary Prevention Strategies for Colorectal Cancer
Acronym
Elucidating the Effects of Vegetable Intake on Intestinal Bile Acid Metabolism to Establish Primary Prevention Strategies for Colorectal Cancer
Scientific Title
Elucidating the Effects of Vegetable Intake on Intestinal Bile Acid Metabolism to Establish Primary Prevention Strategies for Colorectal Cancer
Scientific Title:Acronym
Elucidating the Effects of Vegetable Intake on Intestinal Bile Acid Metabolism to Establish Primary Prevention Strategies for Colorectal Cancer
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is an intervention trial focused not on the intake of a single nutrient but on dietary modification; its aim is to clarify how interventions designed to increase habitual vegetable intake affect bile acid metabolism in the intestine.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to investigate how interventions designed to increase habitual vegetable intake affect the gut microbiota and bowel movement frequency.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bile acid levels in feces
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Active vegetable consumption
Interventions/Control_2
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
living in the local community
Key exclusion criteria
Regular users of dietary fiber supplements
Regular users of laxatives
People with gastrointestinal disorders
People with chronic conditions
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Saito |
Organization
Hiroshima International University
Division name
Department of Clinical Nutrition, Faculty of Health and Wellness Sciences
Zip code
737-0112
Address
5-1-1, Hirokoshingai, Kure, Hiroshima
TEL
0823-73-8254
saito-y@hirokoku-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Saito |
Organization
Hiroshima International University
Division name
Department of Clinical Nutrition, Faculty of Health and Wellness Sciences
Zip code
737-0112
Address
5-1-1, Hirokoshingai, Kure, Hiroshima
TEL
0823-73-8254
Homepage URL
saito-y@hirokoku-u.ac.jp
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Hiroshima International University
Address
5-1-1, Hirokoshingai, Kure, Hiroshima
Tel
0823-69-6034
HIU.Kenkyu@josho.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
| 2026 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 25 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069858
