UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between arterial function and the ability to produce equol in menopausal or postmenopausal women: focused on intestinal microbiome.
Acronym	The relationship between arterial function and the ability to produce equol in menopausal or postmenopausal women: focused on intestinal microbiome.
Scientific Title	The relationship between arterial function and the ability to produce equol in menopausal or postmenopausal women: focused on intestinal microbiome.
Scientific Title:Acronym	The relationship between arterial function and the ability to produce equol in menopausal or postmenopausal women: focused on intestinal microbiome.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the relationship between equol production, arterial function, dietary factors, and lifestyle habits in menopausal or postmenopausal women, focusing on the gut microbiota.
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The objective of this study is to clarify the relationship among arterial function, the ability to produce equol, dietary factors, and lifestyle habits in menopausal or postmenopausal women, focused on intestinal microbiome.
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	Food
Interventions/Control_1	Taking foods contained soy isoflavones for 3 days.
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	40 years-old <=
Age-upper limit	64 years-old >=
Gender	Female
Key inclusion criteria	1. Subjects who are menopause period or post-menopause within 5 years (self-assessment information). 2. Subjects whose written informed consent has been obtained by her voluntary participations. 3. Subjects whose do not have serious cerebrovascular disease, heart disease, liver disease, kidney disease, digestive system disease, and infectious disease.
Key exclusion criteria	1. Subject who have soy allergies. 2. Subject who have hormone replacement therapy 3. Subject who have the disease that need to have medical treatment, given drugs, receiving general lifestyle guidance, and who are judged as unsuitable for the current study by the principal investigator. 4. Subject who is participating in other clinical trial, or have participated in other clinical trial within 30 days before the informed for consent this study. 5. Subject who is HBV, HCV, or HIV positive in the blood test of this study. 6. Subjects who have been determined ineligible by principal investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name TOUSEN
Organization	National Institutes of Biomedical Innovation, Health and Nutrition
Division name	Department of Food Function and Labeling
Zip code	162-8636
Address	1-23-1 Toyama, Shinjuku-ku,Tokyo
TEL	03-3203-8063
Email	tousen@nibiohn.go.jp

Public contact
Name of contact person	1st name Yuko Middle name Last name TOUSEN
Organization	National Institutes of Biomedical Innovation, Health and Nutrition
Division name	Department of Food Function and Labeling
Zip code	162-8636
Address	1-23-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3203-8063
Homepage URL
Email	tousen@nibiohn.go.jp

Sponsor
Institute	National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department

Funding Source
Organization	DANON Institute of Japan Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of National Institutes of Biomedical Innovation, Health and Nutrition
Address	7-6-8 Saitoasagi, Ibaraki, Osaka
Tel	072-641-9829
Email	irb-office@nibiohn.go.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	2019 Year 12 Month 01 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	Suspended
Date of protocol fixation	2019 Year 08 Month 22 Day
Date of IRB	2019 Year 11 Month 11 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2022 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	2019 Year 11 Month 20 Day
Last modified on	2020 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044034