UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025434
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email stg@nakamura-u.ac.jp

Sponsor
Institute Nakamura Gakuen University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029276

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.