UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060351 |
|---|---|
| Receipt number | R000069042 |
| Scientific Title | Observational Study on the Relationship Between Meal Duration Measured in Test Meals and Energy Intake in Daily Life |
| Date of disclosure of the study information | 2026/01/14 |
| Last modified on | 2026/01/14 15:37:48 |
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Basic information
Public title
Observational Study on the Relationship Between Meal Duration Measured in Test Meals and Energy Intake in Daily Life
Acronym
Relationship Between Meal duration and Energy Intake
Scientific Title
Observational Study on the Relationship Between Meal Duration Measured in Test Meals and Energy Intake in Daily Life
Scientific Title:Acronym
Relationship Between Meal duration and Energy Intake
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prevent obesity and diabetes, people are often advised to eat slowly. However, the scientific examination of eating slowly has not yet been sufficiently conducted. Furthermore, whether someone eats slowly or quickly has largely depended on self-reporting until now. Therefore, we measured meal duration with various test foods and clarified that meal duration is positively related to the number of chews, number of bites, gender, and age. We have also already confirmed the reproducibility and consistency of the test meals. Though we have demonstrated that meal duration and chewing time measured with test foods serve as indicators reflecting individual eating behaviors, it remains unclear whether these indicators are related to meal duration and total energy intake in daily life. Thus, in this study, we adjusted for gender and aim to clarify whether various parameters measured with test foods (meal duration, number of chews, number of bites, tempo) are related to eating habits such as daily energy intake, dinner meal duration, and number of meals per day.
Basic objectives2
Others
Basic objectives -Others
This is a study to clarify the relationship between food intake and meal duration.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the relationship between meal duration, number of chews, number of chews per bite, eating tempo as measured during the test meal, and total energy and nutrient intake adjusted by sex
Key secondary outcomes
the relationship between meal duration and number of chews measured during the test meal and dinner meal duration, dinner energy intake, and dinner start time.
the relationship between BMI and meal duration and number of chews measured during the test meal, total energy intake and nutrient intake and dinner energy intake.
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
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Participants will be asked to eat the test meal, 300kcal microwave pizza. The meal duration will be measured by analyzing the food remaining on the plate every 15 seconds via video using image analysis software to measure the area, or by visual assessment. A stopwatch will be used to time the meal. The number of chews, number of bites, and eating tempo will also be measured. Starting the morning after the test, participants will be asked to record all three meals in the food recording app for at least 7 days within one month. They will also be asked to record the meal duration on a recording sheet at the same time.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals who have received sufficient explanation about participation in this study and have provided written consent of their own free will, based on a full understanding.
2. Individuals who are at least 20 years old but under 60 years old at the time of obtaining consent.
Key exclusion criteria
1. Individuals currently undergoing treatment for underlying conditions such as poorly controlled diabetes (HbA1c > 7%) or kidney disease (self-reported)
2. Others deemed inappropriate by the principal investigator or co-investigators
Target sample size
40
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, Kutsukakecho, Toyoake, Aichi
TEL
0562-93-2329
katsumi.iizuka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kastumi |
| 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, Kutsukakecho, 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
Katsumi Iizuka
Funding Source
Organization
Manpei Suzuki Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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, Kutsukakecho, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
藤田医科大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 14 | 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
| 2026 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069042
