UMIN-CTR Clinical Trial

Basic information
Public title	Difference in taste of bread by the way of spreading butter
Acronym	Difference in taste of bread by the way of spreading butter
Scientific Title	Difference in taste of bread by the way of spreading butter
Scientific Title:Acronym	Difference in taste of bread by the way of spreading butter
Region	Japan

Condition
Condition	Feeding and swallowing disorder
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify impacts of methods of spreading butter on bread on taste and easiness of bread.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective evaluation of taste, easiness of eating, easiness of spreading butter on bread
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	To change butter from solid to liquid
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Male and female who apply this project by viewing the poster of the recruitment of this research
Key exclusion criteria	Those who have dementia, stroke, declined oral function, diet limitation, and food allergy.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Junichi Middle name Last name Furuya
Organization	Tokyo Medical and Dental University
Division name	Oral Health Sciences for Community Welfare
Zip code	1138549
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-4545
Email	furuya.ohcw@tmd.ac.jp

Public contact
Name of contact person	1st name Junichi Middle name Last name Furuya
Organization	Tokyo Medical and Dental University
Division name	Oral Health Sciences for Community Welfare
Zip code	1138549
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-4545
Homepage URL
Email	furuya.ohcw@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB TMDU
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel	03-5803-5404
Email	furuya.ohcw@tmd.ac.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

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 20 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	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 20 Day
Date of IRB	2018 Year 11 Month 16 Day
Anticipated trial start date	2018 Year 11 Month 16 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 07 Month 20 Day
Last modified on	2022 Year 07 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038151