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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017496
Receipt No. R000020278
Scientific Title Cross-sectional study of relationship between nutrient intake and life-style related disease
Date of disclosure of the study information 2015/05/18
Last modified on 2019/05/16

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Basic information
Public title Cross-sectional study of relationship between nutrient intake and life-style related disease
Acronym Cross-sectional study of relationship between nutrient intake and life-style related disease
Scientific Title Cross-sectional study of relationship between nutrient intake and life-style related disease
Scientific Title:Acronym Cross-sectional study of relationship between nutrient intake and life-style related disease
Region
Japan

Condition
Condition Life-style related disease
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate relationship of lipid intake and life-style related disease including type of obesity-related gene
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Blood lipid levels and diabetes markers
Key secondary outcomes Cardio Ankle Vascular Index, Blood pressure

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
18 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria General healthy men and women
Key exclusion criteria Patients under treatment of dyslipidemia and diabetes
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Takeuchi
Organization Toyama College
Division name Food and nutrition
Zip code
Address 444 mizuguchi, gankai-zi, Toyama-shi, Toyama
TEL 076-436-5168
Email wistar1111@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Takeuchi
Organization Toyama College
Division name Food and nutrition
Zip code
Address 444 mizuguchi, gankai-zi, Toyama-shi, Toyama
TEL 076-436-5168
Homepage URL
Email wistar1111@gmail.com

Sponsor
Institute Toyama College
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization
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
2015 Year 05 Month 18 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 Open public recruiting
Date of protocol fixation
2015 Year 03 Month 06 Day
Date of IRB
2016 Year 03 Month 09 Day
Anticipated trial start date
2015 Year 06 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The relationship between nutrient intake and life--style related disease will be evaluated for normal men and women in a cross-sectional manner, including type of obesity-related gene (FTO, ADRB3, UCP1 and ADRB2).

Management information
Registered date
2015 Year 05 Month 11 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020278

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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