UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039869
Receipt number R000045466
Scientific Title Mid-Cooling with ice slurry ingestion in hot environment improves sprint performance in female?
Date of disclosure of the study information 2020/03/18
Last modified on 2020/03/18 16:34:07

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Basic information

Public title

Mid-Cooling with ice slurry ingestion in hot environment improves sprint performance in female?

Acronym

Effects of mid-cooling on exercise performance in female

Scientific Title

Mid-Cooling with ice slurry ingestion in hot environment improves sprint performance in female?

Scientific Title:Acronym

Effects of mid-cooling on exercise performance in female

Region

Japan


Condition

Condition

none

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether mid-cooling with ice slurry ingestion improves subsequent high-intensity intermittent exercise performance.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sprint performance, Rectal temperature, skin temperature, thermal sensation, thermal comfort, rating of perceived exertion, urine specific gravity, 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

35 years-old >=

Gender

Female

Key inclusion criteria

Healthy 20-35 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

12


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 or person

Institute

Waseda university

Institute

Department

Personal name



Funding Source

Organization

National Strength and Conditioning Association JAPAN

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

2020 Year 03 Month 18 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

Preinitiation

Date of protocol fixation

2020 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2020 Year 08 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

2020 Year 03 Month 18 Day

Last modified on

2020 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045466


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name