UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056594 |
|---|---|
| Receipt number | R000064677 |
| Scientific Title | A study on the effect of rhythmic stimulation of metronome on masticatory tempo |
| Date of disclosure of the study information | 2024/12/28 |
| Last modified on | 2025/06/27 13:34:37 |
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Basic information
Public title
A study on the effect of rhythmic stimulation of metronome on masticatory tempo
Acronym
metronome and masticatory tempo
Scientific Title
A study on the effect of rhythmic stimulation of metronome on masticatory tempo
Scientific Title:Acronym
metronome and masticatory tempo
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
After adjusting for age and BMI, we will first determine the relationship between mastication tempo and muscle mass, muscle strength (grip strength), physical exercise capacity, body size, and chewing ability. Next, we will examine whether or not mastication tempo and chewing frequency increase by adjusting to the rhythm of a metronome.
Basic objectives2
Others
Basic objectives -Others
This study will clarify whether mastication tempo is related to age, gender, body size, muscle strength, and physical function. It will also examine the difference between the actual measured values and the time the individual anticipated in advance that it would take to eat, and the relationship with the individual's normal food intake status.
Next, we will examine whether chewing in accordance with a metronome affects eating time, chewing tempo, and total number of chews. Each of them will be asked to eat 1/4 slice of pizza (Maruha Nichiro frozen pizza, 1 slice, 100 g and its substitute) to the tempo (none, 40 bpm, 80 bpm, 160 bpm). Or, eat one slice of French bread (4 slices, 1 cm thick) in the same way, one slice at a time to the tempo (none, 40 bpm, 80 bpm, 160 bpm).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For the effects of metronome rhythm (4 groups) on mastication tempo and total meal time, multiple comparisons will be made by Tukey method after One Way ANOVA in the case without adjustment. In the case with adjustment, age, gender, and BMI will be used as covariates, and the comparison of chewing tempo and number of chews in the metronome rhythm (4 groups) will be performed by analysis of covariance.
Key secondary outcomes
The dependent variable was mastication tempo (number of chews), and the independent variables were body size, grip strength, physical function, total energy and nutrient intake, age, sex, and BMI.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention method consisted of eating pizza to the rhythm of a metronome (40bpm). No rhythm is assumed to be the control.
Interventions/Control_2
The intervention method consisted of eating pizza to the rhythm of a metronome (80bpm). No rhythm is assumed to be the control.
Interventions/Control_3
The intervention method consisted of eating pizza to the rhythm of a metronome (160bpm). No rhythm is assumed to be the control.
Interventions/Control_4
No rhythm is assumed to be the control.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. subjects who, after receiving a full explanation and with full understanding, give their free written consent to participate in this study
2. subjects who are between 20 and 65 years old at the time of consent (regardless of gender for the purpose of the pilot study)
Key exclusion criteria
1. those with underlying medical conditions (e.g., diabetes, hypertension, etc.)
2. others who are deemed inappropriate by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsumi |
| Middle name | |
| Last name | Iizuka |
Organization
Fujita health university
Division name
Department of Clinical Nutrition, faculty of Medicine,
Zip code
470-1192
Address
1-98 Dengakugakubo, KUtsukakemachi, Toyoake, Aichi
TEL
0562-93-2329
katsumi.iizuka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | katsumi |
| Middle name | |
| Last name | Iizuka |
Organization
Fujita health university
Division name
Department of Clinical Nutrition, faculty of Medicine,
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukakemachi, Toyoake, Aichi
TEL
0562-93-2329
Homepage URL
katsumi.iizuka@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita health university
Institute
Department
Personal name
Funding Source
Organization
Fujita health university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukakemachi, Toyoake, Aichi
Tel
0562-93-2865
katsumi.iizuka@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HM24-004
Org. issuing International ID_1
Ethics Review Committee of Fujita Health University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
藤田医科大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
33
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
Main results already published
Date of protocol fixation
| 2024 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064677
