UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054480 |
|---|---|
| Receipt number | R000062226 |
| Scientific Title | A study of meal intake rate measurement methods and differences between different types of meals |
| Date of disclosure of the study information | 2024/05/27 |
| Last modified on | 2025/06/27 13:33:53 |
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Basic information
Public title
A study of meal intake rate measurement methods and differences between different types of meals
Acronym
A study of meal intake rate measurement methods and differences between different types of meals
Scientific Title
A study of meal intake rate measurement methods and differences between different types of meals
Scientific Title:Acronym
A study of meal intake rate measurement methods and differences between different types of meals
Region
| Japan |
Condition
Condition
normal subjects
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will determine the association between nutritional disorders and rate of dietary intake by measuring the overall diet and the rate of intake of each nutrient using two test diets adjusted to the same energy level.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will test to see if there is a difference in the rate of food intake between test meal 1 and 2.
Key secondary outcomes
1. Correlate meal intake speed by image measurement with meal intake speed by visual inspection and with chewing tempo.
2. Correlate meal intake time by visual inspection with time measured by bite scan and time confirmed from images.
3. Correlate meal intake time and speed with body size, and identify differences with gender and age.
4. Test meal intake speed of Test Meal 2 to see if it changes with the order in which meals are eaten.
5. Identify correlations between daily energy, protein intake, fat intake, carbohydrate intake, and food intake and meal intake speed.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Test meal 1 is a pizza or pancake, and test meal 2 is a single serving of rice, hamburger steak, and salad.
(i) Test to confirm the method for quantifying eating speed
For the speed of eating test meal 1, by measuring the rate of decrease in area,
The speed is measured by measuring the speed of the decrease in area. At the same time, the number of times of chewing by bite scan will be measured.
For the calibration of bite scan, chewing test
Gummy bears such as Glucolam are used to calibrate the bite scan. The beginning and end of the meal are measured with a stopwatch.
Check if the results of visual inspection and the results of area measurement by image analysis measurement software are consistent.
Interventions/Control_2
Test meal 1 is a pizza or pancake, and test meal 2 is a single serving of rice, hamburger steak, and salad.
(2) Test to see the difference in eating speed by changing the type of meal.
After one month, test meal 2 is eaten (vegetables first, rice and hamburger steak later), and the speed is measured by measuring the rate of decrease in area. The above chewing tests (bite scan and gummy test) will be conducted in the same way.
Interventions/Control_3
Test meal 1 is a pizza or pancake, and test meal 2 is a single serving of rice, hamburger steak, and salad.
(iii) Test to see if eating speed changes with the order in which meals are eaten.
For Test Meal 2, we conducted a test to see if the speed of eating changed depending on the order in which the participants ate their meals.
(2) Eating hamburger steak and rice first, then vegetables, on two different days during one month.
(2) Eat hamburger and rice first, then vegetables, on two different days during a month. The above mastication tests (BiteScan and Gummy test) should be conducted in the same way.
Chewing test (bite scan, gummy bear test) is also conducted in the same way.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. staff and students who have given their free and voluntary written consent to participate in this study after receiving a full explanation and with full understanding
2. staff and students who are between 20 and 65 years of age at the time of obtaining consent
Key exclusion criteria
Other research subjects deemed inappropriate by the principal investigator
Target sample size
20
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, Graduate school of medicine
Zip code
470-1192
Address
1,98, Dengakugakubo, Kutsukakecho, toyoake, aichi, japan
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 univefrsity
Division name
Department of Clinical Nutrition, Graduate school of medicine
Zip code
470-1192
Address
1,98, dengakugakubo, kutsukakecho, toyoake, aichi, japan
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
fujita health university
Address
1,98, dengakugakubo,kutsukakecho, aichi, japan
Tel
0562-93-2865
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HM23-472
Org. issuing International ID_1
Fujita health university
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
藤田医科大学 （愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 27 | 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
41
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 | 03 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2025 | 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 | 05 | Month | 24 | 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=R000062226
