UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002688 |
|---|---|
| Receipt number | 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 13:03:54 |
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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
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
ntsubo@nih.go.jp
Sponsor or person
Institute
National institute of Health and Nutrition
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003282
