UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038646 |
|---|---|
| Receipt number | R000044034 |
| Scientific Title | The relationship between arterial function and the ability to produce equol in menopausal or postmenopausal women: focused on intestinal microbiome. |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2020/09/08 17:47:33 |
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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
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
tousen@nibiohn.go.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044034
