UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034740 |
|---|---|
| Receipt number | 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 | 2023/05/06 17:32:18 |
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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
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
smatsui@fc.jwu.ac.jp
Sponsor or person
Institute
Japan Women's University
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039601
