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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030245
Receipt No. R000034484
Scientific Title Association between soy food consumption and arterial stiffness
Date of disclosure of the study information 2017/12/04
Last modified on 2017/12/04

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Basic information
Public title Association between soy food consumption and arterial stiffness
Acronym Soy food consumption and arterial stiffness
Scientific Title Association between soy food consumption and arterial stiffness
Scientific Title:Acronym Soy food consumption and arterial stiffness
Region
Japan

Condition
Condition Arterial stiffness
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to evaluate the relationship between soy food consumption and arterial stiffness using cross-sectional data.
Basic objectives2 Others
Basic objectives -Others The aim of the present study is to evaluate the relationships between soy food consumption, especially the intake of fermented soy products and soy isoflavone, and arterial stiffness, independent of the classical atherosclerotic risk factors including systemic inflammation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brachial-ankle pulse wave velocity
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
35 years-old <=
Age-upper limit
69 years-old >=
Gender Male
Key inclusion criteria Men aged 35-69 years who participated in the baseline survey of a prospective cohort study from November 2009 to June 2012 in Tokushima Prefecture, Japan and who received a brachial-ankle pulse wave velocity measurement at the baseline survey.
Key exclusion criteria Exclusion criteria is as follows: 1) men with a history of ischemic heart disease or stroke; 2) men with a low right or left ankle brachial index (<= 0.9); 3) men whose estimated daily total energy intake was extremely high (>4,000 kcal/day) or low (<1,000 kcal/day); and 4) men who had no data on serum lipid or high-sensitivity C-reactive protein, frequency of soy products intakes, or any clinical factors.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu Uemura
Organization Tokushima University Graduate School
Division name Department of Preventive Medicine
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima 770-8503, Japan
TEL +81886337073
Email uemura.hirokazu@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Uemura
Organization Tokushima University Graduate School
Division name Department of Preventive Medicine
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima 770-8503, Japan
TEL +81886337073
Homepage URL
Email uemura.hirokazu@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization The Japanese Ministry of Education, Culture, Sports, Science and Technology, and the Japan Society for the Promotion of Science.
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
Address
Tel
Email

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
2017 Year 12 Month 04 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 Completed
Date of protocol fixation
2009 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analyses are finished.

Management information
Registered date
2017 Year 12 Month 04 Day
Last modified on
2017 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034484

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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