UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017496 |
|---|---|
| Receipt number | 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 | 2024/05/30 17:45:07 |
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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 | Hiroyuki |
| Middle name | |
| Last name | Takeuchi |
Organization
Toyama College
Division name
Food and nutrition
Zip code
9300193
Address
444 mizuguchi, gankai-zi, Toyama-shi, Toyama
TEL
076-436-5168
wistar1111@gmail.com
Public contact
Name of contact person
| 1st name | Takeuchi |
| Middle name | |
| Last name | Hiroyuki |
Organization
Toyama College
Division name
Food and nutrition
Zip code
9300193
Address
444 mizuguchi, gankai-zi, Toyama-shi, Toyama
TEL
076-436-5168
Homepage URL
wistar1111@gmail.com
Sponsor or person
Institute
Toyama College
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
Toyama College
Address
444 Mizugchi Gankaiji Toyama
Tel
076-436-5176
kyoumu@toyama-c.ac.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
| 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
Suspended
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
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020278
