UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057826 |
|---|---|
| Receipt number | R000066101 |
| Scientific Title | The Second Meal Effect of Different Types of Snacking |
| Date of disclosure of the study information | 2025/05/10 |
| Last modified on | 2025/05/10 15:03:20 |
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Basic information
Public title
The Second Meal Effect of Different Types of Snacking
Acronym
The Second Meal Effect of Different Types of Snacking
Scientific Title
The Second Meal Effect of Different Types of Snacking
Scientific Title:Acronym
The Second Meal Effect of Different Types of Snacking
Region
| Japan |
Condition
Condition
lifestyle disease
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exprore changes in post-dinner blood glucose levels due to different snacks in healthy adults between the ages of 18 and 59 years, using four different snacking interventions, including no snack at 5 p.m.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose IAUC value 5 hours after dinner
Key secondary outcomes
Highest blood glucose level after dinner, blood glucose IAUC level 2 hours after snack, highest blood glucose level, appetite, concentration, fatigue, subjective assessment of sleep, objective assessment of sleep, free fatty acids in blood, gut flora
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
no snack
Interventions/Control_2
Snack of Fruit Foods
Interventions/Control_3
cookie
Interventions/Control_4
rice cookie
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(i) Healthy adults between the ages of 18 and 59 years old at the time of obtaining consent.
(ii) A person who is able to participate in the specified research period and visit the laboratory on the specified date
(iii) A person who can download the smartphone application to his/her own cell phone and use it.
Key exclusion criteria
(i) Those whose usual eating and sleeping habits are extremely irregular (including those who work night shifts or shift work)
(ii) Those who regularly use sleeping pills, sleeping supplements, or drugs or supplements that affect blood glucose levels
(iii) Those who are participating or will participate in other clinical studies
(iv) Those who plan to travel to time zones during the study period and two weeks prior to the start of the study.
(v) Those who are using an implantable medical device such as a pacemaker (vi) Those who are eating the following foods (milk, eggs, and rice)
(vi) Those who are allergic to the following foods (milk, egg, wheat, soybean, beef, mackerel, chicken, pork, apple, gelatin)
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-0037
Address
Hiroshima-shi Kasumi 1-2-3, Hiroshima
TEL
082-257-5167
yutahara@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-0037
Address
Hiroshima-shi Kasumi 1-2-3, Hiroshima
TEL
082-257-5167
Homepage URL
yutahara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
AOHATA Corporation, Kewpie Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
Tel
082-257-1551
iryo-sinsa@office.hiroshima-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
広島大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 10 | 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 | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | 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
| 2025 | Year | 05 | Month | 10 | Day |
Last modified on
| 2025 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066101
