UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025434 |
|---|---|
| Receipt number | R000029276 |
| Scientific Title | Influence of lunch made from local agricultural products on atherosclerotic disease related factors |
| Date of disclosure of the study information | 2017/01/07 |
| Last modified on | 2016/12/27 16:00:33 |
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Basic information
Public title
Influence of lunch made from local agricultural products on atherosclerotic disease related factors
Acronym
Influence of lunch made from local agricultural products on atherosclerotic disease related factors
Scientific Title
Influence of lunch made from local agricultural products on atherosclerotic disease related factors
Scientific Title:Acronym
Influence of lunch made from local agricultural products on atherosclerotic disease related factors
Region
| Japan |
Condition
Condition
Arteriosclerotic Disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to verify whether it contributes to improvement of obesity, visceral fat accumulation and arteriosclerotic disease by eating of regional agricultural products lunch boxes,.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase or decrease of visceral fat area before and after
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Provide meals made from regional agricultural products to research subjects at weekly lunches (Monday - Friday) once a day for 3 weeks.
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
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male
Key inclusion criteria
Waist perimeter: 85 cm or more
BMI: 25 or more and less than 35
Key exclusion criteria
Alcohol drinker: alcohol 210 g / week or more
Persons possessing health problems related to the results of this study
Those who judged that this research is not feasible
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayo Oobe |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutrition Science
Zip code
Address
5-7-1 Befu Jyonan-ku Fukuoka-city
TEL
092-851-2594
stg@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayo Oobe |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutrition Science
Zip code
Address
5-7-1 Befu Jyonan-ku Fukuoka-city
TEL
092-851-2594
Homepage URL
stg@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Agriculture, Forestry and Fisheries
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 | 01 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 27 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029276
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
