UMIN-CTR Clinical Trial

Basic information
Public title	A cross-sectional study of the effects of masticatory functional food intake on masticatory performance
Acronym	A cross-sectional study of the effects of masticatory functional food intake
Scientific Title	A cross-sectional study of the effects of masticatory functional food intake on masticatory performance
Scientific Title:Acronym	A cross-sectional study of the effects of masticatory functional food intake
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Dental medicine Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of eating masticatory functional food on the performance of masticatory movements and muscle activities of the oral cavity in healthy young and elderly (robust and frail) individuals.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The muscle activities of the masseter and the duration of mastication when eating masticatory functional food compared to the control food
Key secondary outcomes	The changing rate of the tongue pressure and biting force after the experiment

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	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Food
Interventions/Control_1	eating of masticatory functional food
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	healthy young and elderly individuals who are able to give informed consents
Key exclusion criteria	1. Individuals who have dysphagia 2. Individuals who have severe disorder of mastication 3. Individuals who are not able to give informed consents 4. Individuals whom the investigators judge to be inappropriate
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koichiro Matsuo
Organization	Fujita Health University
Division name	Department of Dentistry, School of Medicine
Zip code
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL	0562-93-9098
Email	kmatsuo@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Koichiro Matsuo
Organization	Fujita Health University
Division name	Department of Dentistry, School of Medicine
Zip code
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL	0562-93-9098
Homepage URL	http://dentistryfujita-hu.jp/research/project.html
Email	kmatsuo@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Food Care Co., Ltd Division of Oral and Maxillofacial Biology, Matsumoto Dental University
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	2017 Year 07 Month 01 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	2017 Year 05 Month 01 Day
Date of IRB	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2018 Year 04 Month 01 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2018 Year 07 Month 01 Day
Date analysis concluded	2019 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date	2017 Year 05 Month 19 Day
Last modified on	2019 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031400