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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027461
Receipt No. 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

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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
Email 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
Email tyschiba@nibiohn.go.jp

Sponsor
Institute National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031461

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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