UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038808 |
|---|---|
| Receipt number | R000044250 |
| Scientific Title | Effect of reduced salt diet using "dashi" in school lunch for healthy Japanese students : non-randomize control trial at Elementary and junior high school |
| Date of disclosure of the study information | 2019/12/06 |
| Last modified on | 2020/06/05 09:45:44 |
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Basic information
Public title
Effect of reduced salt diet using "dashi" in school lunch for healthy Japanese students : non-randomize control trial at Elementary and junior high school
Acronym
Effect of reduced salt diet using "dashi" in school lunch for healthy Japanese students : non-randomize control trial at Elementary and junior high school
Scientific Title
Effect of reduced salt diet using "dashi" in school lunch for healthy Japanese students : non-randomize control trial at Elementary and junior high school
Scientific Title:Acronym
Effect of reduced salt diet using "dashi" in school lunch for healthy Japanese students : non-randomize control trial at Elementary and junior high school
Region
| Japan |
Condition
Condition
Healthy students
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of school lunch using "dashi" for reducing sodium intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in the sensitive of sodium on the taste tests
Key secondary outcomes
changes in the state of sodium intake on the basis of the questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
reduced salt diet using "dashi" 45day
education of reducing sodium 1day
Interventions/Control_2
education of reducing sodium 1day
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
| 9 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
students eating of school lunch
Key exclusion criteria
students with a serious allergies
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Nohara |
Organization
Kio University
Division name
Department of Health Nutrition
Zip code
6350832
Address
4-2-2 Umaminaka, Koryo-cho, Kitatsukagi-gun, Nara Prefecture
TEL
0745541601
j.nohara@kio.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Nohara |
Organization
Kio University
Division name
Department of Health Nutrition
Zip code
6350832
Address
4-2-2 Umaminaka, Koryo-cho, Kitatsukagi-gun, Nara Prefecter
TEL
0745541601
Homepage URL
j.nohara@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitatsukagi-gun, Nara Prefecture
Tel
0745541601
j.nohara@kio.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
| 2019 | Year | 12 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 06 | Day |
Last modified on
| 2020 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044250
