UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of food chewing for the athletic capability improvement.
Title of the study (Brief title)	Effects of food chewing for the athletic capability improvement.
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of food chewing for the athletic capability improvement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Time of 100m dash
Key secondary outcomes	Evaluation items for chewing consciousness and chewing behavior are questionnaire survey form. Chewing ability is evaluated using gum method and dental prescale.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are 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	Food Behavior,custom
Interventions/Control_1	Chew 2 pieces of gum (1.5g/piece ) for 20 minutes per once, 3 times a day for 30 days.
Interventions/Control_2	Do not take gum as much as possible for 30 days.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The adult student over 20 years old belongs to the track and field club of University. Subjects are explained by the research representative the purpose of the research and the flow of the survey in writing and oral, understand the purpose of this survey, consent to participation and inquiries. Subjects are confirmed orally by the research representative that there is no problem or not in eating and swallowing in daily life.
Key exclusion criteria	Researcher inquires orally whether eating or swallowing is problematic in daily life, excludes those judged as having problems and those who judged that test food is concerned about allergies.
Target sample size	40

Research contact person
Name of lead principal investigator	MIYUKI Kibayashi
Organization	University of Shizuoka, Junior College
Division name	Department of Dental Hygiene
Address	2-2-1 OSHIKA,SURUGA-KU,SHIZUOKA-CITY 422-8021 JAPAN
TEL	054-202-2672
Email	kibamiyu@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	MIYUKI Kibayashi
Organization	University of Shizuoka, Junior College,
Division name	Department of Dental Hygiene
Address	2-2-1 OSHIKA,SURUGA-KU,SHIZUOKA-CITY 422-8021 JAPAN
TEL	054-202-2672
Homepage URL
Email	kibamiyu@u-shizuoka-ken.ac.jp

Sponsor
Institute	University of Shizuoka, Junior College
Institute
Department

Funding Source
Organization	Lotte Co.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	国士舘大学（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 21 Day
Anticipated trial start date	2016 Year 11 Month 23 Day
Last follow-up date
Date of closure to data entry	2016 Year 12 Month 26 Day
Date trial data considered complete	2017 Year 01 Month 31 Day
Date analysis concluded	2017 Year 05 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 22 Day
Last modified on	2018 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028681