UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051658 |
|---|---|
| Receipt number | R000058946 |
| Scientific Title | A study on the effects of breakfast habits on health conditions -Randomized Crossover Trials - |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2023/07/27 13:53:53 |
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Basic information
Public title
A study on the effects of breakfast habits on health conditions
-Randomized Crossover Trials -
Acronym
A study on the effects of breakfast habits
Scientific Title
A study on the effects of breakfast habits on health conditions
-Randomized Crossover Trials -
Scientific Title:Acronym
A study on the effects of breakfast habits
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the health effects of eating a warm high-protein breakfast versus a cold high-carbohydrate breakfast for two weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fNIRS signals in the lateral prefrontal cortex and reaction time during RVIP-Task and DVT.
Number of responses in AUT
Autonomic nervous system by ECG
Key secondary outcomes
Subjective evaluation questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
After skipping breakfast for 2 weeks, participants take a warm high-protein meal for breakfast for 2 weeks.
About 2 hours after breakfast of the pre- and post-test days, a set of cognitive tasks will be performed.
Interventions/Control_2
After skipping breakfast for 2 weeks, participants take a cold high-carbonhydrate meal for breakfast for 2 weeks.
About 2 hours after breakfast of the pre- and post-test days, a set of cognitive tasks will be performed.
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
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy participant
2. A participant who has breakfast everyday
3. A participant who is active during the day
4. A participant who does not take any oral medications during the study period
5. Right-handed
6. A participant who is not allergic to the food related to the study
Key exclusion criteria
1. A participant who does not follow the diet restrictions on the test days
2. A participant who takes oral medications on the test days
3. A participant who does not get enough sleep the night before the test days
4. A participant who takes any drinks containing caffeine or alcohol after 22:00 the night before the test days
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Hasegawa |
Organization
NeU Corporation
Division name
NA
Zip code
101-0048
Address
2-2 Niikura Building, Kandatsukasamachi, Chiyoda-ku, Tokyo
TEL
0362609050
kiyoshi.hasegawa@neu-brains.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Okada |
Organization
NeU Corporation
Division name
neuromarketing BU
Zip code
101-0048
Address
2-2 Niikura Building, Kandatsukasamachi, Chiyoda-ku, Tokyo
TEL
0362609050
Homepage URL
takuya.okada@neu-brains.com
Sponsor or person
Institute
NeU Corporation
Institute
Department
Personal name
Funding Source
Organization
YOSHINOYA HOLDINGS CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University Knowledge Cast Co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
-
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
| 2024 | Year | 01 | Month | 31 | 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
| 2023 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058946
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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