UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055946 |
|---|---|
| Receipt number | R000063936 |
| Scientific Title | Effects of pre-meal gum chewing on the autonomic nervous system: A randomized cross-over trial |
| Date of disclosure of the study information | 2024/10/25 |
| Last modified on | 2025/05/21 21:31:43 |
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Basic information
Public title
Effects of pre-meal gum chewing on the autonomic nervous system
Acronym
Effects of pre-meal gum chewing on the autonomic nervous system
Scientific Title
Effects of pre-meal gum chewing on the autonomic nervous system: A randomized cross-over trial
Scientific Title:Acronym
Effects of pre-meal gum chewing on the autonomic nervous system: A randomized cross-over trial
Region
| Japan |
Condition
Condition
Healthy Japanese adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of pre-meal gum chewing on the post-meal autonomic nervous system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
autonomic nervous system (LF/HF): from pre-meal to after 90 minutes meal
Key secondary outcomes
flash glucose monitoring
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
10 minutes of free gum chewing before lunch, and no intervention
Interventions/Control_2
No intervention, and 10 minutes of free gum chewing before lunch
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who obtained written informed consent before the participation, and more can measure habitual chewing ability.
Key exclusion criteria
Suffering from disease medicine that affects the autonomic nervous system
Receiving dietary instructions or guidance
Have a pacemaker
Difficulty deglutition
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshiko |
| Middle name | |
| Last name | Kuwano |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Science
Zip code
422-8526
Address
52-1 Yada, Suruga Ward, Shizuoka City, Shizuoka, 422-8526, JAPAN
TEL
054-264-5513
kuwano@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Toshiko |
| Middle name | |
| Last name | Kuwano |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Science
Zip code
422-8526
Address
52-1 Yada, Suruga Ward, Shizuoka City, Shizuoka, 422-8526, JAPAN
TEL
054-264-5513
Homepage URL
kuwano@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka
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
The Ethics Committee of the University of Shizuoka
Address
52-1 Yada, Suruga Ward, Shizuoka City, Shizuoka, 422-8526, JAPAN
Tel
054-264-5103
koho1@u-shizuoka-ken.ac.jp
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
| 2024 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063936
