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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002688
Receipt No. R000003282
Scientific Title The effect of model meal intake on metabolic syndrome
Date of disclosure of the study information 2009/10/29
Last modified on 2010/01/15

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Basic information
Public title The effect of model meal intake on metabolic syndrome
Acronym The effect of model meal intake on metabolic syndrome
Scientific Title The effect of model meal intake on metabolic syndrome
Scientific Title:Acronym The effect of model meal intake on metabolic syndrome
Region
Japan

Condition
Condition Metabolic syndrome
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In Japan, Specific Health Check Up and Specific Health Counseling for the metabolic syndrome was begun in 2008.

However, a reasonable and effective methods of nutrition education are required because there is a limit in the number of specialists such as registered dietitians and public health nurse for Specific Health Counseling.
Furthermore, it is necessary to develop new methods to evaluate dietary intake.

Then, we will examine the effect of model meal intake on dietary behavior modification and metabolic syndrome. The other purpose is to develop the new technique methods for evaluating dietary intake by comparing the difference of model meal and daily meal.

As a result, it gropes for the possibility to a decrease and the medical expense reduction in obesity and the metabolic syndrome of our country.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Body weight
The number of steps
Eating behavior
Blood biochemistry test
(low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride, impaired fasting glucose,HbA1c etc.)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 The group to consume 4 set of model meal within 4 weeks during trial period for 2 months (energy ; approximately 550kcal, salt; approximately 2g, type; frozen meal).
Interventions/Control_2 The group to consume 11 set of model meal within 4 weeks during trial period for 2 months (energy ; approximately 550kcal, salt; approximately 2g, type; frozen meal).
Interventions/Control_3 The group to consume 0 set of model meal within 4 weeks during trial period for 2 months.
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
74 years-old >=
Gender Male
Key inclusion criteria Person who is a category of pre-metabolic syndrome.
Person who is a category of metabolic syndrome for 2 years and would not like to receive the Specific Health Counseling at health promotion center after Specific Health Check Up for metabolic syndrome.
Key exclusion criteria Person who is a category of pre-metabolic syndrome and metabolic syndrome and would like to receive the Specific Health Counseling at health promotion center after Specific Health Check Up for metabolic syndrome.
Person who has specific food allergy.
Person who has particular disease.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyo Tsuboyama-Kasaoka
Organization National institute of Health and Nutrition
Division name Center for Collaboration and Partnership- project for International Research and Development
Zip code
Address 1-23-1 Toyama, Shinjuku-ku, Tokyo, JAPAN
TEL 03-3203-5721
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyo Tsuboyama-Kasaoka
Organization National institute of Health and Nutrition
Division name Center for Collaboration and Partnership- project for International Research and Development
Zip code
Address
TEL
Homepage URL
Email ntsubo@nih.go.jp

Sponsor
Institute National institute of Health and Nutrition
Institute
Department

Funding Source
Organization National institute of Health and Nutrition
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Nichirei Foods Co.
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
2009 Year 10 Month 29 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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 29 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 29 Day
Last modified on
2010 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003282

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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