UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of fluid intake on change in ocular blood flow with exhaustive exercise in healthy subjects.
Title of the study (Brief title)	Effect of fluid intake on change in ocular blood flow with exhaustive exercise in healthy subjects.
Region	Japan

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

Objectives
Narrative objectives1	To investigate whether the fluid intake influences the response of ocular blood flow to exhaustive exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) ocular blood flow before exercise, immediately after exercise, immediately after fluid intake and at 120 min after fluid intake. 2) urine specific gravity before exercise and at 120 min after fluid intake.
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	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	1) cycling exercise until exhaustion (1 time) and electrolyte-containing water intake (500 mL). 2) wash out period over 7 days. 3) cycling exercise until exhaustion (1 time) and no electrolyte-containing water intake (0 mL).
Interventions/Control_2	1) cycling exercise until exhaustion (1 time) and no electrolyte-containing water intake (0 mL). 2) wash out period over 7 days. 3) cycling exercise until exhaustion (1 time) and no electrolyte-containing water intake (500 mL).
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	25 years-old >=
Gender	Male
Key inclusion criteria	1) the person who does not have chronic disease 2) agreement with this study after explanation 3) the training situation does not change during experiment 4) the eating situation does not change during experiment 5) the person who does not take any drug or supplement
Key exclusion criteria	1) a brain concussion and disturbance of consciousness have been experienced in the past 2) the person who have orthopedic sharp pain and neurogic symptom
Target sample size	17

Research contact person
Name of lead principal investigator	Katsuhiko Suzuki
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima Tokorozawa Saitama
TEL	04-2947-6898
Email	katsu.suzu@waseda.jp

Public contact
Name of contact person	Tsukasa Ikemura
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima Tokorozawa Saitama
TEL	04-2947-7128
Homepage URL
Email	ikemura-t@aoni.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2015 Year 11 Month 30 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 01 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 27 Day
Last modified on	2016 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023039