UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019461 |
|---|---|
| Receipt number | 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 16:26:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ym.sakurai.hsc@cmn.tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Health Administration Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022417
