UMIN-CTR Clinical Trial

Basic information
Public title	Effects of ice slurry ingestion on tympanic temperature during exercise
Acronym	Effects of ice slurry ingestion on tympanic temperature during exercise
Scientific Title	Effects of ice slurry ingestion on tympanic temperature during exercise
Scientific Title:Acronym	Effects of ice slurry ingestion on tympanic temperature during exercise
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of ice slurry ingestion on tympanic temperature and cycling performance in college rugby football players during high-intensity intermittent exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Continuous measurement of tympanic temperature
Key secondary outcomes	Temporal artery temperature, Subjective fatigue parameters (VAS) etc

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Single ingestion of ice slurry.
Interventions/Control_2	Single ingestion of room temperature ice slurry.
Interventions/Control_3	Single ingestion of room temperature water.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1) Healthy male 2) College rugby players
Key exclusion criteria	1) Subjects who have a disease 2) Subjects who have a serious disease history 3) Subjects who are judged as unsuitable for the study by the principal investigator etc
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Naohiko Middle name Last name Kohtake
Organization	Keio University
Division name	Graduate School of System Design and Management
Zip code	223-0061
Address	4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL	045-564-2580
Email	kohtake@sdm.keio.ac.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Hirata
Organization	Keio University
Division name	Graduate School of System Design and Management
Zip code	223-0061
Address	4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL	045-564-2580
Homepage URL
Email	akihiro.hirata@sdm.keio.ac.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	TAISHO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	TAISHO PHARMACEUTICAL CO., LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Review Committee of Sports Medicine Research Center, Keio University
Address	4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
Tel	045-566-1090
Email	rxb03102@nifty.com

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	慶應義塾大学（神奈川県）

Other administrative information
Date of disclosure of the study information	2020 Year 02 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	18
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	2020 Year 01 Month 24 Day
Date of IRB	2020 Year 01 Month 21 Day
Anticipated trial start date	2020 Year 02 Month 18 Day
Last follow-up date	2020 Year 03 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 27 Day
Last modified on	2020 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044792