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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034740
Receipt No. R000039601
Scientific Title Infulence of energy metabolizm skipped breakfast in healthy young women.
Date of disclosure of the study information 2018/11/02
Last modified on 2019/05/03

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Basic information
Public title Infulence of energy metabolizm skipped breakfast in healthy young women.
Acronym Infulence of energy metabolizm skipped breakfast in healthy young women.
Scientific Title Infulence of energy metabolizm skipped breakfast in healthy young women.
Scientific Title:Acronym Infulence of energy metabolizm skipped breakfast in healthy young women.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clalify the influence of skipped breakfast(difference of fasting time) on resting and postprandial energy metabolizm.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes resting and postprandial energy expenditure
Key secondary outcomes respiratory quatient, urea ketone body, urea glycogen, heart rate, body temparature

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 After fasting for 12h, we mesure on fasting O2 and CO2,heart rate. After breakfast(ham cheese sand, vegetable juice) eating, we mesure on O2 and CO2, heart rate in 1h and 2h.
Interventions/Control_2 After fasting for 16h, we mesure on fasting O2 and CO2,heart rate. After breakfast(ham cheese sand, vegetable juice) eating, we mesure on O2 and CO2, heart rate in 1h and 2h.
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
25 years-old >=
Gender Female
Key inclusion criteria stable menstrual cycle and no underlying disease, obteined informed consent
Key exclusion criteria unstable menstrual cycle, underlying disease
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Sadako
Middle name
Last name Matsui
Organization Japan Women's Ubuversity
Division name Faculity of human sciences and design, food and nutrition
Zip code 112-8681
Address 2-8-1 mejirodai bunkyo-ku, Tokyo, Japan
TEL 03-5981-3432
Email smatsui@fc.jwu.ac.jp

Public contact
Name of contact person
1st name Sadako
Middle name
Last name Matsui
Organization Japan Women's Ubuversity
Division name Faculity of human sciences and design, food and nutrition
Zip code 112-8681
Address 2-8-1 mejirodai bunkyo-ku, Tokyo, Japan
TEL 03-5981-3432
Homepage URL
Email smatsui@fc.jwu.ac.jp

Sponsor
Institute Japan Women's University
Institute
Department

Funding Source
Organization Japan Women's University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Women's University
Address 2-8-1 mejirodai bunkyoku Tokyo Japan
Tel 03-5981-3275
Email n-shienatlas@jwu.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 日本女子大学(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 02 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 No longer recruiting
Date of protocol fixation
2018 Year 08 Month 22 Day
Date of IRB
2018 Year 08 Month 22 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2020 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
2018 Year 11 Month 01 Day
Last modified on
2019 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039601

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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