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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019461
Receipt No. R000022417
Scientific Title Effects of breakfast support for college students on the ability to taste
Date of disclosure of the study information 2015/10/23
Last modified on 2016/12/13

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Basic information
Public title Effects of breakfast support for college students on the ability to taste
Acronym Effects of breakfast support for college students on the ability to taste
Scientific Title Effects of breakfast support for college students on the ability to taste
Scientific Title:Acronym Effects of breakfast support for college students on the ability to taste
Region
Japan

Condition
Condition Taste dysfunction
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Breakfast help done that breakfast intake number is increased , to reveal whether to improve the ability to taste
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in taste at 3 month after intervention
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group:provide the following 1-3(For 3 months)
1.Provision of breakfast(12times)
2.Seminars about diet and nutrion(1time)
3.Provision of breakfast recipe(6times)
Interventions/Control_2 Control group:
For 3 months, The subject lives a normal life
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
35 years-old >
Gender Male and Female
Key inclusion criteria 1.Students of tokyo medical and dental university
2.Skipping breakfast more than twice a week healthy volunteer without diseases
3.Students who understand the content of the study
Key exclusion criteria 1.Smoker
2.Pathologically confirmed taste dysfunction
3.Subjects who are considered to be inappropriate for participation by reserchers with responsibilities in this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunari Miyazaki
Organization Tokyo Medical and Dental University
Division name Health Administration Center
Zip code
Address 1-5-45 Yushima, Bunkyo, Tokyo
TEL 03-5803-5081
Email miyazaki.pilm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimi Sakurai
Organization Tokyo Medical and Dental University
Division name Health Administration Center
Zip code
Address 1-5-45 Yushima, Bunkyo, Tokyo
TEL 03-5803-5081
Homepage URL
Email ym.sakurai.hsc@cmn.tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Health Administration Center
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2015 Year 10 Month 23 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 Completed
Date of protocol fixation
2015 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 02 Day
Last follow-up date
2015 Year 12 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
2015 Year 10 Month 22 Day
Last modified on
2016 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022417

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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