UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045639 |
|---|---|
| Receipt number | R000052103 |
| Scientific Title | Cross-sectional evaluation of the relationship between intestinal bile acid concentration and diet, defecation, and intestinal microbiota |
| Date of disclosure of the study information | 2021/10/15 |
| Last modified on | 2021/10/02 08:58:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of habitual dietary and life-style factors on bile acid metabolism in the intestinal tract
Acronym
Effects of habitual dietary and life-style factors on bile acid metabolism in the intestinal tract
Scientific Title
Cross-sectional evaluation of the relationship between intestinal bile acid concentration and diet, defecation, and intestinal microbiota
Scientific Title:Acronym
Cross-sectional evaluation of the relationship between intestinal bile acid concentration and diet, defecation, and intestinal microbiota
Region
| Japan |
Condition
Condition
colon cancer preventiond
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore the habitual lifestyle and dietary factors that influence intestinal bile acid metabolism.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to evaluate the relationship between fecal bile acid concentration, gut microbiota, diet, and defecation status.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal bile acid concentration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Non
Key exclusion criteria
Non
Target sample size
70
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 Hearth 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 Hearth 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
Japan Science and Technology Agency
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
Yamagata Prefectural Yonezawa University of Nutrition Sciences
Address
6-15-1, Touri-machi, Yonezawa, Yamagata 992-0025, Japan
Tel
0238-22-7330
jimu@yone.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
| 2021 | Year | 10 | Month | 15 | 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
70
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We recruited subjects for one year.
Management information
Registered date
| 2021 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052103
