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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024948
Receipt No. R000028681
Scientific Title Effects of food chewing for the athletic capability improvement.
Date of disclosure of the study information 2016/11/23
Last modified on 2018/03/09

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Basic information
Public title Effects of food chewing for the athletic capability improvement.
Acronym Effects of food chewing for the athletic capability improvement.
Scientific Title Effects of food chewing for the athletic capability improvement.
Scientific Title:Acronym 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
1st name
Middle name
Last name MIYUKI Kibayashi
Organization University of Shizuoka, Junior College
Division name Department of Dental Hygiene
Zip code
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
1st name
Middle name
Last name MIYUKI Kibayashi
Organization University of Shizuoka, Junior College,
Division name Department of Dental Hygiene
Zip code
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)

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 国士舘大学(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 11 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
2016 Year 11 Month 21 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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