UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057288 |
|---|---|
| Receipt number | R000065486 |
| Scientific Title | Investigation of Individual Differences in Blood Glucose Response: Focusing on Meal Timing and Aerobic Exercise Stimuli |
| Date of disclosure of the study information | 2025/03/14 |
| Last modified on | 2025/03/14 14:32:53 |
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Basic information
Public title
Investigation of Individual Differences in Blood Glucose Response: Focusing on Meal Timing and Aerobic Exercise Stimuli
Acronym
Investigation of Individual Differences in Blood Glucose Response
Scientific Title
Investigation of Individual Differences in Blood Glucose Response: Focusing on Meal Timing and Aerobic Exercise Stimuli
Scientific Title:Acronym
Investigation of Individual Differences in Blood Glucose Response: Focusing on Meal Timing and Aerobic Exercise Stimuli
Region
| Japan |
Condition
Condition
Healthy young adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate individual differences in blood glucose response based on meal timing stimuli.
Basic objectives2
Others
Basic objectives -Others
This study aims to investigate individual differences in blood glucose response based on meal timing stimuli.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
24-hour blood glucose level
Key secondary outcomes
energy intake
meal timing
urinary metabolome
physical activity
appetite
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Under free-living conditions, participants will consume appropriately portioned meals based on their energy expenditure at their own timing. The meals will be nutritionally balanced according to dietary intake guidelines.
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
| 18 | years-old | <= |
Age-upper limit
| 44 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals aged between 18 and 44 years at the time of consent acquisition.
Individuals who self-report no medical conditions and are deemed healthy by the researcher.
Individuals who have received a thorough explanation of the study, fully understand it, and provide written informed consent of their own free will.
Key exclusion criteria
Individuals with highly irregular eating habits (e.g., skipping meals, unbalanced diet, frequent snacking, or significantly irregular meal times).
Individuals who consume 40g or more of protein or amino acid supplements per day on a regular basis.
Individuals who have been diagnosed with an eating disorder.
Individuals with food allergies.
Individuals diagnosed with lifestyle-related diseases (e.g., diabetes, hypertension).
Smokers.
Individuals deemed unable to undergo an exercise stress test by the researcher.
Any other individuals deemed unsuitable as study participants.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Yamamoto |
Organization
Fukuoka University
Division name
Graduate School of Sports and Health Science
Zip code
8140180
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
0928716631
gd230502@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Yamamoto |
Organization
Fukuoka University
Division name
Graduate School of Sports and Health Science
Zip code
8140180
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
0928716631
Homepage URL
gd230502@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Taiki Yamamoto
Funding Source
Organization
Fukuoka 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
Fukuoka University Medical Ethics Committee
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
Tel
092-801-1011(3193)
fumed-ethics@fukuoka-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | 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
| 2025 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 03 | Month | 14 | Day |
Last modified on
| 2025 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065486
