UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027400 |
|---|---|
| Receipt number | R000031400 |
| Scientific Title | A cross-sectional study of the effects of masticatory functional food intake on masticatory performance |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2019/11/20 20:40:00 |
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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
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
kmatsuo@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031400
