UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048676 |
|---|---|
| Receipt number | R000055467 |
| Scientific Title | Relationship between skipping breakfast and subjective symptoms and academic performance in university students |
| Date of disclosure of the study information | 2022/08/16 |
| Last modified on | 2024/02/16 09:50:26 |
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Basic information
Public title
Relationship between skipping breakfast and subjective symptoms and academic performance in university students
Acronym
Relationship between skipping breakfast and subjective symptoms and academic performance in university students
Scientific Title
Relationship between skipping breakfast and subjective symptoms and academic performance in university students
Scientific Title:Acronym
Relationship between skipping breakfast and subjective symptoms and academic performance in university students
Region
| Japan |
Condition
Condition
Health adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of eating or skipping breakfast on subjective symptoms and academic performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
academic performance
Key secondary outcomes
subjective symptoms
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Eating breakfast
Interventions/Control_2
Skipping breakfast
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
| 19 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy female University student without food allergy
Key exclusion criteria
Student who did no fill out quiestionnaires
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Nakade |
Organization
University of Hyogo
Division name
Department of food science and nutrition
Zip code
670-0092
Address
1-1-2 Shinzaike-honcho, himeji-city, Hyogo
TEL
079-292-9334
nakade@shse.u-hyogo.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Nakade |
Organization
University of Hyogo
Division name
Department of food science and nutrition
Zip code
670-0092
Address
1-1-2 Shinzaike-honcho, himeji-city, Hyogo
TEL
079-292-9334
Homepage URL
nakade@shse.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
University of Hyogo
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Hyogo
Address
1-1-2 Shinzaike-honcho, himeji-city, Hyogo
Tel
079-292-1515
u-hyogo@ofc.u-hyogo.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
| 2022 | Year | 08 | Month | 16 | 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
50
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 09 | 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
| 2022 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055467
