UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between soy food consumption and arterial stiffness
Title of the study (Brief title)	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	Hirokazu Uemura
Organization	Tokushima University Graduate School
Division name	Department of Preventive Medicine
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	Hirokazu Uemura
Organization	Tokushima University Graduate School
Division name	Department of Preventive Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 07 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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