UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019950
Receipt number R000023039
Scientific Title Effect of fluid intake on change in ocular blood flow with exhaustive exercise in healthy subjects.
Date of disclosure of the study information 2015/11/30
Last modified on 2016/11/29 10:53:52

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Basic information

Public title

Effect of fluid intake on change in ocular blood flow with exhaustive exercise in healthy subjects.

Acronym

Effect of fluid intake on change in ocular blood flow with exhaustive exercise in healthy subjects.

Scientific Title

Effect of fluid intake on change in ocular blood flow with exhaustive exercise in healthy subjects.

Scientific Title:Acronym

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

1st name
Middle name
Last name Katsuhiko Suzuki

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


Address

2-579-15 Mikajima Tokorozawa Saitama

TEL

04-2947-6898

Email

katsu.suzu@waseda.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsukasa Ikemura

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


Address

2-579-15 Mikajima Tokorozawa Saitama

TEL

04-2947-7128

Homepage URL


Email

ikemura-t@aoni.waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



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)



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

2015 Year 11 Month 30 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

No longer recruiting

Date of protocol fixation

2016 Year 01 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023039


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name