UMIN-CTR Clinical Trial

Basic information
Public title	The effect of sex differences on pre-cooling and post-cooling with ice slurry ingestion during exercise in hot environment
Acronym	Sex difference in cooling effect during exercise in hot environment
Scientific Title	The effect of sex differences on pre-cooling and post-cooling with ice slurry ingestion during exercise in hot environment
Scientific Title:Acronym	Sex difference in cooling effect during exercise in hot environment
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of sex differences on pre-cooling and post-cooling on exercise-induced hyperthermia in hot environment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rectal temperature, skin temperature, thermal sensation, thermal comfort, rating of perceived exertion, sweat rate, urine osmotic pressure, oxygen intake, carbon dioxide intake, respiratory exchange ratio, heart rate
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ice slurry
Interventions/Control_2	Control water
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	39 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy 20-39 year old adult men and women Those who have no change in their lifestyle Those who have exercise habits Those who can go to Waseda University Tokorozawa Campus 3 times in total Those who are within the normal menstrual cycle (25th to 38th) (female)
Key exclusion criteria	Those who have stopped exercising by a doctor Those who have had a heart illness, stroke or heat stroke in the past Person with diabetes Those with orthopedic pain and neurological symptoms Those with a history of compression fractures due to osteoporosis
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Isao Middle name Last name Muraoka
Organization	Waseda university
Division name	Faculty of sport sciences
Zip code	359-1192
Address	2-579-15 Mikajima, Tokorozawa, Saitama
TEL	04-2947-7128
Email	imuraoka@waseda.jp

Public contact
Name of contact person	1st name Risa Middle name Last name Iwata
Organization	Waseda university
Division name	Graduate school of sport sciences
Zip code	359-1192
Address	2-579-15 Mikajima, Tokorozawa, Saitama
TEL	04-2947-7128
Homepage URL
Email	rs.1107ynn.0522@toki.waseda.jp

Sponsor
Institute	Waseda university
Institute
Department

Funding Source
Organization	Yamaha Motor Foundation for Sports
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Waseda university
Address	2-579-15 Mikajima, Tokorozawa, Saitama
Tel	04-2947-7128
Email	rs.1107ynn.0522@toki.waseda.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	2019 Year 09 Month 12 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	24
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	2019 Year 06 Month 25 Day
Date of IRB	2019 Year 10 Month 26 Day
Anticipated trial start date	2019 Year 08 Month 26 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	2019 Year 08 Month 21 Day
Last modified on	2020 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043059