UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045850 |
|---|---|
| Receipt number | R000052341 |
| Scientific Title | Effects of Food Intake on Masseter Muscle Activity and Exercise Performance |
| Date of disclosure of the study information | 2021/10/25 |
| Last modified on | 2022/04/26 11:30:11 |
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Basic information
Public title
Effects of Food Intake on Masseter Muscle Activity and Exercise Performance
Acronym
Effects of Food Intake on Masseter Muscle Activity and Exercise Performance
Scientific Title
Effects of Food Intake on Masseter Muscle Activity and Exercise Performance
Scientific Title:Acronym
Effects of Food Intake on Masseter Muscle Activity and Exercise Performance
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effects of a single intake of four test foods on masseter muscle activity and exercise performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Masseter muscle activity
Occlusal force and occlusal contact area test
Energy expenditure
Exercise performance
Grip strength
Vertical jump
Center of gravity balance (static and dynamic)
Heart rate index
Height, weight, and BMI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
5
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Test food 1
Interventions/Control_2
Test food 2
Interventions/Control_3
Test food 3
Interventions/Control_4
Test food 4
Interventions/Control_5
No intake
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Those who can eat test foods (for preference)
(2)Those who have no dental symptoms and are not under dental treatment (regular dental cleaning is acceptable)
(3)Those who have all teeth except wisdom teeth.
(4)Those who have no physical symptoms and are able to perform motor function assessment.
(5)Those who have received sufficient explanation of the purpose and content of the study, have the ability to consent, have voluntarily volunteered to participate with a good understanding, and have agreed to participate in this study in writing.
Key exclusion criteria
(1) Those who have symptoms that may affect intake test foods
(2) Those who may develop allergies related to the study
(3) Those who are judged by the study representative to be inappropriate to participate in this study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Osawa |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
oosawa_kenji@lotte.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Osawa |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
oosawa_kenji@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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
| 2021 | Year | 10 | Month | 25 | 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
12
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
| 2021 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 23 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052341
