UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054216 |
|---|---|
| Receipt number | R000061604 |
| Scientific Title | Influence of wake-up time and intervention with rice balls and coffee beverages on the circadian rhythm of core body temperature. |
| Date of disclosure of the study information | 2024/04/24 |
| Last modified on | 2024/04/24 14:10:32 |
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Basic information
Public title
Influence of wake-up time and intervention with rice balls and coffee beverages on the circadian rhythm of core body temperature.
Acronym
Influence of wake-up time and intervention with rice balls and coffee beverages on the circadian rhythm of core body temperature.
Scientific Title
Influence of wake-up time and intervention with rice balls and coffee beverages on the circadian rhythm of core body temperature.
Scientific Title:Acronym
Influence of wake-up time and intervention with rice balls and coffee beverages on the circadian rhythm of core body temperature.
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the changes in the circadian rhythm of core body temperature by conducting interventions involving wake-up time restriction (adjusted to match the first class), breakfast intake (rice balls, a common staple food in this study), or intake of coffee beverages containing caffeine upon waking in college students who do not have a habit of eating breakfast.
Basic objectives2
Others
Basic objectives -Others
We will also investigate changes in sleep-wake rhythms and performance.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
changes in the circadian rhythm of core body temperature
Key secondary outcomes
Changes in sleep, activity level, electrocardiogram, glucose concentration in interstitial fluid, cortisol concentration in saliva, performance, daily dietary intake, daily activities, daily mood, and OSA sleep survey.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
No breakfast
Interventions/Control_2
Rice ball
Interventions/Control_3
Coffee beverage
Interventions/Control_4
Rice ball, Coffee beverage
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. University students aged 18 and above.
2. Individuals without a breakfast consumption habit (those who usually engage in lifestyles such as consuming 'snacks, fruits, dairy products, flavored beverages only' in the morning,
supplementing nutrients with tablets, nutrition drinks only,' or 'not eating anything' for five or more days a week).
3. Individuals available to participate during the specified examination period designated by us and able to visit the research laboratory on specified dates.
4. Individuals able to download and use a mobile app on their own mobile device.
Key exclusion criteria
1. Individuals with extremely irregular eating and sleeping habits.
2. Individuals with health conditions (those with medications affecting metabolism, mental disorders, severe cardiovascular diseases, cancer, pregnant individuals, individuals with a history of gastrointestinal surgery).
3. Individuals engaged in shift work or night shift jobs
4. Individuals who regularly use sleeping pills or sleep supplements
5. Individuals who typically consume caffeine-containing beverages equivalent to 400mg or more of caffeine per day (approximately 3 cups for coffee in a mug (200ml each), approximately 10 cups for green tea, hojicha, or oolong tea, or more than 6 cups for black tea)
6. Individuals with food allergies to the target food ingredients or those who experience significant physical changes in response to caffeine intake."
7. Students attending lectures given by the Department of Public Health, Hiroshima University.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Department of Public Health and Health Policy
Zip code
734-0037
Address
Hiroshima-shi Minami-ku Kasumi 1-2-3
TEL
07026426103
yutahara@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Department of Public Health and Health Policy
Zip code
734-0037
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
TEL
07026426103
Homepage URL
yutahara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Noevia, TOKIWA Pharmaceutical Co.,Ltd
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
| 2024 | Year | 04 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061604
| Research Plan | |
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