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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038646
Receipt No. R000044034
Scientific Title The relationship between arterial function and the ability to produce equol in postmenopausal women: focused on intestinal microbiome.
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/20

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria (1) Subjects who are 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 smoking habit.
4. 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.
5. 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.
6. Subject who is HBV, HCV, or HIV positive in the blood test of this study.
7. Subject who is serum FSH hormone concentration < 40 IU/mL and oestrogen hormone (E2) concentration > 20 pg/mL.
8. 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 Preinitiation
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
2019 Year 11 Month 20 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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