UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030245 |
|---|---|
| Receipt number | 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 09:58:20 |
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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
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
uemura.hirokazu@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034484
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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