UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032346 |
|---|---|
| Receipt number | R000036892 |
| Scientific Title | Influence of meal intervention on clock gene expression and hormone in saliva |
| Date of disclosure of the study information | 2018/04/23 |
| Last modified on | 2018/04/23 15:29:27 |
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Basic information
Public title
Influence of meal intervention on clock gene expression and hormone in saliva
Acronym
Six consecutive days of meal intervention
Scientific Title
Influence of meal intervention on clock gene expression and hormone in saliva
Scientific Title:Acronym
Six consecutive days of meal intervention
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of breakfast skipping on energy metabolism, blood glucose, and clock gene expression rhythm
Basic objectives2
Others
Basic objectives -Others
Exercise nutrition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Energy metabolism at sixth day of meal intervention (energy expenditure, substrate oxidation, and respiratory quotient measured using metabolic chamber)
Continuous blood level from first to sixth meal intervention
Expression of clock gene in blood and saliva at sixth day of meal intervention
Heart rate variability at sixth day of meal intervention
Melatonin onset at sixth day of meal intervention
Key secondary outcomes
Body composition between first and last meal intervention
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
6 days of meal intervention (3 meals)
Interventions/Control_2
6 days of meal intervention (breakfast skipping)
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Eating breakfast everyday and living a regular wake/sleep
Key exclusion criteria
Smoker, thyroid disease, diabetes
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Satoh |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sloop Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-5643
mk-satoh@outlook.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Satoh |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sloop Medicine
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL
029-853-5643
Homepage URL
mk-satoh@outlook.com
Sponsor or person
Institute
Sports Medicine, Graduate School of Comprehensive Human Sciences, University of Tsyjyva
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for JSPS Research Fellow
Grants-in-Aid for Scientific Research
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
Address
Tel
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
| 2018 | Year | 04 | Month | 23 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 23 | Day |
Last modified on
| 2018 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036892
