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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026804
Receipt No. R000030773
Scientific Title The effects wearing a face mask on energy metabolism
Date of disclosure of the study information 2017/06/30
Last modified on 2019/05/07

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Basic information
Public title The effects wearing a face mask on energy metabolism
Acronym The effects wearing a face mask on energy metabolism
Scientific Title The effects wearing a face mask on energy metabolism
Scientific Title:Acronym The effects wearing a face mask on energy metabolism
Region
Japan

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

Objectives
Narrative objectives1 To investigate how wearing a mask effects energy metabolism and cardiopulmonary function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Energy metabolism
Key secondary outcomes Electro-cardiogram, Body motion, Respiratory rate

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Measurement of energy metabolism wearing a face mask(Order-made)
Interventions/Control_2 Measurement of energy metabolism wearing a face mask
Interventions/Control_3 Measurement of energy metabolism without wearing a face mask
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
55 years-old >=
Gender Male and Female
Key inclusion criteria Healthy individuals in the age range of 20 to 55
Key exclusion criteria 1. Individuals who have no history of disease in the respiratory system, metabolic system, cardiovascular system
2. Individuals who are on medication
Target sample size 92

Research contact person
Name of lead principal investigator
1st name Naoyuki
Middle name
Last name EBINE
Organization Doshisha University
Division name Faculty of Health & Sports Science
Zip code 6100394
Address 1-3 Miyakodani Tatara Kyotanabe City, Kyoto, JAPAN
TEL 0774-65-7535
Email nebine@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name Naoyuki
Middle name
Last name EBINE
Organization Doshisha University
Division name Faculty of Health & Sports Science
Zip code 6100394
Address 1-3 Miyakodani Tatara Kyotanabe City, Kyoto, JAPAN
TEL 0774-65-7535
Homepage URL
Email nebine@mail.doshisha.ac.jp

Sponsor
Institute Doshisha University
Institute
Department

Funding Source
Organization Nagoya Institute of Clinical Pharmacology
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Doshisha University Code of Human Subject Research Ethics
Address Karasuma-higashi-iru, Imadegawa-dori, Kamigyo-ku, Kyoto-shi
Tel 075-251-3120
Email ji-rinri@mail.doshisha.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

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 30 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 30
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
2016 Year 11 Month 10 Day
Date of IRB
2016 Year 11 Month 10 Day
Anticipated trial start date
2016 Year 11 Month 25 Day
Last follow-up date
2018 Year 10 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
2017 Year 03 Month 31 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030773

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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