UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056626 |
|---|---|
| Receipt number | R000064679 |
| Scientific Title | Validation of the intra-individual reproducibility of meal rate measurements and the relationship between meal rate and metabolic parameters. |
| Date of disclosure of the study information | 2025/01/25 |
| Last modified on | 2025/09/03 17:56:00 |
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Basic information
Public title
Validation of the intra-individual reproducibility of meal rate measurements and the relationship between meal rate and metabolic parameters.
Acronym
Individual differences in eating speed
Scientific Title
Validation of the intra-individual reproducibility of meal rate measurements and the relationship between meal rate and metabolic parameters.
Scientific Title:Acronym
Individual differences in eating speed
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will clarify the following
1) Investigate the reproducibility of meal intake rate and eating order for the test meal*.
2) The relationship between meal intake speed and metabolic parameters (BMI, SMI, body fat mass, HbA1c, eGFR, UA, T-Chol, TG, HDL-C, non-HDL-C, blood pressure, and grip strength) in response to the test meal
3) Relationship between the speed of food intake and the number of times of chewing for the test meal
4) Relationship between the speed of food intake on the test meal and nutrient intake based on the food intake frequency survey
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The speed of food intake for the test meal and whether the order of eating differs from the first to the second meal is compared by a corresponding t-test (or Wilcoxon signed rank test if the distribution is not normal).
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
First test meal and Second test meal (about 2 weeks)
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
. Selection Criteria
1. upon full understanding of the subject's participation in this study, after having received a full explanation,
1. subjects who have given written consent of their own free will after full explanation and with full understanding
2. subjects who are between 20 and 60 years of age at the time of consent
Key exclusion criteria
1. Subjects with food allergies
2. other subjects deemed inappropriate by the principal investigator or principal study investigator
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, Kutsukake-cho, 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, Kutsukake-cho, 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
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, Kutsukake-cho, toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HM24-136
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
| 2025 | Year | 01 | Month | 25 | 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 | 10 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | 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 | 01 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064679
