UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055281 |
|---|---|
| Receipt number | R000063166 |
| Scientific Title | Do urine compositions related to protein metabolism change when skipping breakfast in healthy adults?: A preliminary study |
| Date of disclosure of the study information | 2024/08/19 |
| Last modified on | 2025/08/19 10:25:38 |
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Basic information
Public title
How protein metabolism is affected by skipping breakfast
Acronym
Protein metabolism and skipping breakfast
Scientific Title
Do urine compositions related to protein metabolism change when skipping breakfast in healthy adults?: A preliminary study
Scientific Title:Acronym
Protein metabolism after skipping breakfast
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of urine components related to protein metabolism after eating breakfast and after skipping breakfast
Basic objectives2
Others
Basic objectives -Others
Protein metabolism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary [15N]-ammonia end-product enrichment after eating breakfast and skipping breakfast
Key secondary outcomes
Urinary [15N]-urea end-product enrichment, urinary 3-methylhistidine/creatinine ratio, urinary nitrogen excretion, and urinary ketone enrichment, energy expenditure, carbohydrate oxidation and fat oxidation after eating breakfast and skipping breakfast
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants eat three test meals a day during the first four days of the five-day measurement period. After the washout period (more than 3 days), participants eat three test meals a day for the first three days of the five-day measurement period, and on the fourth day, they will skip breakfast and eat lunch and dinner.
Interventions/Control_2
Participants eat three test meals a day during the first three days of the five-day measurement period, and on the fourth day they will skip breakfast and eat lunch and dinner. After the washout period (3 days or more), participants eat 3 test meals a day during the first 4 days of the 5-day measurement period.
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students, teachers and other staffs in Toyo University
Key exclusion criteria
No able to eat the test meal
Smoker
Have a medical disease that can affect protein metabolism
Regularly using supplements and medicines
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshizaki |
Organization
Toyo University
Division name
Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11 Akabanedai, Kita-ku, Tokyo
TEL
03-5924-2823
yoshizaki@toyo.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshizaki |
Organization
Toyo University
Division name
Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11 Akabanedai, Kita-ku, Tokyo
TEL
03-5924-2823
Homepage URL
yoshizaki@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
Toyo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo University of Pharmacy and Life Sciences, National Institute of Health and Nutrition
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Concerning Medical Research Involving Human Subjects
Address
2100 Kujirai, Kawagoe-shi, Saitama, Japan 350-8585
Tel
049-239-1440
hoshi@toyo.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
| 2024 | Year | 08 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 20 | 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
| 2024 | Year | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063166
