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

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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 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


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

Value
https://center6.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