UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058490 |
|---|---|
| Receipt number | R000066870 |
| Scientific Title | Influence of Chewing Frequency on Appetite |
| Date of disclosure of the study information | 2025/07/16 |
| Last modified on | 2025/07/16 14:43:58 |
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Basic information
Public title
Influence of Chewing Frequency on Appetite
Acronym
Influence of Chewing Frequency on Appetite
Scientific Title
Influence of Chewing Frequency on Appetite
Scientific Title:Acronym
Influence of Chewing Frequency on Appetite
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Endocrinology and Metabolism | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of chewing frequency on food intake under controlled mealtime conditions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in snack-related energy intake and consumption volume
Key secondary outcomes
Changes in Visual Analog Scale (VAS) scores for Hunger, Fullness, and Appetite
Changes in plasma GLP-1 concentration
Changes in blood glucose levels
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
40 chews condition => washout period => 15 chews condition
Interventions/Control_2
15 chews condition => washout period => 40 chews condition
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
Key inclusion criteria
Male participants aged 18 years or older
Body Mass Index (BMI) between 18.5 and 25 kg/m^2
Key exclusion criteria
Individuals with food allergies
Smorkers
Individuals on a restricted diet
Individuals with internal medical or oral surgical conditions currently under treatment
Individuals deemed unable to participate in the study due to impaired comprehension or unstable mental condition
Individuals otherwise deemed unsuitable for the study by the investigators to ensure the quality of data collection
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Nin |
Organization
Kyoto University
Division name
Graduate School of Medicine, Department of Human Health Sciences
Zip code
606-8507
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3946
nin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Nin |
Organization
Kyoto University
Division name
Graduate School of Medicine, Department of Human Health Sciences
Zip code
606-8507
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3946
Homepage URL
nin@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Metropolitan University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University
Address
53, Shogoin, Kawahara-cho, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-u.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
京都大学（京都府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066870
