UMIN-CTR Clinical Trial

Basic information
Public title	Examination of simple measurement method of anaerobic threshold
Acronym	Examination of simple measurement method of anaerobic threshold
Scientific Title	Measurement of anaerobic threshold using blood oxygen saturation -Pilot Study-
Scientific Title:Acronym	Measurement of anaerobic threshold using blood oxygen saturation
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of measurement method of anaerobic threshold using blood oxygen saturation
Basic objectives2	Others
Basic objectives -Others	Verify the validity of the inspection method
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Exercise intensity corresponding to the anaerobic threshold
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Age: 20 -65 years old 2. Sex : Male or Female 3. BMI:18.5 -25.0 kg/m^2 4. Written informed consent
Key exclusion criteria	1. Subjects with severe liver diseases, digestive organ diseases, kidney diseases and heart diseases. 2. Subjects who are planned to participate in other clinical study. 3. Subjects who intend to become pregnant or lactating. 4. Subjects infected with coronavirus (COVID-19) or who fall under close contact with infected persons 5. Subjects with exercise-induced diseases such as exercise-induced arrhythmia and exercise-induced anaphylaxis and exercise equipment disorders 6. Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	244-0806
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3443
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Yuri Middle name Last name Ishii
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	244-0806
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3419
Homepage URL
Email	yuishii@fancl.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	FANCL Corporation Clinical Research Ethics Committee
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
Tel	045-820-3657
Email	akihide_nisihara@fancl.co.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	株式会社ファンケル 総合研究所（神奈川県）

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 01 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	2021 Year 04 Month 22 Day
Date of IRB	2021 Year 04 Month 30 Day
Anticipated trial start date	2021 Year 05 Month 11 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The validity of the new method is verified by determining the anaerobic threshold point from the blood oxygen saturation during exercise load and comparing the exercise intensity at that point with the existing method.

Management information
Registered date	2021 Year 05 Month 12 Day
Last modified on	2021 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050457