UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027461 |
|---|---|
| Receipt number | R000031461 |
| Scientific Title | Intervention study of attitude toward health foods/dietary supplements in university students. |
| Date of disclosure of the study information | 2017/07/31 |
| Last modified on | 2020/05/25 09:59:47 |
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Basic information
Public title
Intervention study of attitude toward health foods/dietary supplements in university students.
Acronym
Intervention study of attitude toward health foods/dietary supplements in university students.
Scientific Title
Intervention study of attitude toward health foods/dietary supplements in university students.
Scientific Title:Acronym
Intervention study of attitude toward health foods/dietary supplements in university students.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of lesson on attitude toward health foods/dietary supplements in university students
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Attitude toward health foods/dietary supplements (Questionnaire survey before/after lesson)
Key secondary outcomes
Status and purpose of health foods/dietary supplements usage (Questionnaire survey before lesson)
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
lesson about health foods/dietary supplements (60 minutes, 1 time)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
University students
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Chiba |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
National Institute of Health and Nutrition
Division name
Department of Food Function and Labeling
Zip code
162-8636
Address
1-23-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3203-8063
tyschiba@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Chiba |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Food Function and Labeling
Zip code
162-8636
Address
1-23-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3203-8063
Homepage URL
tyschiba@nibiohn.go.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Research Ethics Committee of National Institutes of Biomedical Innovation, Health and Nutrition
Address
7-6-8, Saito-Asagi, Ibaraki City, Osaka
Tel
072-641-9829
irb-office@nibiohn.go.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
岩手医科大学（岩手県）Iwate Medical University
帝京大学（東京都）Teikyo University
武庫川女子大学（兵庫県）Mukogawa Women’s University
麻布大学（神奈川県）Azabu University
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
328
Results
We conducted the lecture based intervention on university students about dietary supplements(DS). Before the intervention, the students understanding of DS was deficient. Post-intervention, their knowledge levels had significantly improved, such as DS are safe because they are just food, and other 12 topics. Despite there being a greater number of pharmaceutical students who had a correct understanding of DS before the intervention, these students still showed improvement after the lecture.
Results date posted
| 2020 | Year | 05 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 05 | 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
| 2017 | Year | 05 | Month | 23 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031461
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| Registered date | File name |
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