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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032346
Receipt No. 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

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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
Email 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
Email mk-satoh@outlook.com

Sponsor
Institute Sports Medicine, Graduate School of Comprehensive Human Sciences, University of Tsyjyva
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036892

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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