UMIN-CTR Clinical Trial

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
Email	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
Email	saito-y@hirokoku-u.ac.jp

Sponsor
Institute	Hiroshima International University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052103