UMIN-CTR Clinical Trial

Basic information
Public title	Effects of solar ultraviolet exposure during outdoor exercise on physical and mental condition
Acronym	Exercise and solar ultraviolet exposure
Scientific Title	Effects of solar ultraviolet exposure during outdoor exercise on physical and mental condition
Scientific Title:Acronym	Exercise and solar ultraviolet exposure
Region	Japan

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

Objectives
Narrative objectives1	To examine the effects of solar ultraviolet exposure on stress response after exercise outside
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Oxidative stress, Anti-oxidative potency
Key secondary outcomes	Immune function

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	1)pre-exercise measurement 2)To put sunscreen or placebo on skin 3)exercise inside, 60 min 4)post-exercise measurement 5)6 h post-exercise measurement 6)24 h post-exercise measurement
Interventions/Control_2	1)pre-exercise measurement 2)To put sunscreen or placebo on skin 3)exercise outside, 60 min 4)post-exercise measurement 5)6 h post-exercise measurement 6)24 h post-exercise measurement
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	18 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy males and females
Key exclusion criteria	1)Subjects who have skin disease or cutaneous photosensitivity 2)Subjects who have orthopedic or medical disorder
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuhiko Eda
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code
Address	2-579-15, Mikajima, Tokorozawa, Saitama
TEL	04-2947-6721
Email	nob-eda@aoni.waseda.jp

Public contact
Name of contact person	1st name Middle name Last name Nobuhiko Eda
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code
Address	2-579-15, Mikajima, Tokorozawa, Saitama
TEL	04-2947-6721
Homepage URL
Email	nob-eda@aoni.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Shiseido Co., Ltd.
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
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 10 Month 03 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 01 Day
Date of IRB	2018 Year 07 Month 10 Day
Anticipated trial start date	2018 Year 10 Month 03 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 10 Month 03 Day
Last modified on	2020 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039182