UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029584
Receipt number R000033795
Scientific Title Effect of pre-exercise carbohydrate ingestion on high intensity intermittent exercise performance
Date of disclosure of the study information 2017/10/16
Last modified on 2020/07/28 09:28:11

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Basic information

Public title

Effect of pre-exercise carbohydrate ingestion on high intensity intermittent exercise performance

Acronym

Pre-exercise carbohydrate ingestion and exercise performance

Scientific Title

Effect of pre-exercise carbohydrate ingestion on high intensity intermittent exercise performance

Scientific Title:Acronym

Pre-exercise carbohydrate ingestion and exercise performance

Region

Japan


Condition

Condition

Healthy subject

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the influence of pre-exercise ingestion of different carbohydrate on high intensity intermittent exercise performance.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

cyclic ergometer

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

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

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Single pre-exercise ingestion of carbohydrate

Interventions/Control_2

Single pre-exercise ingestion of glucose

Interventions/Control_3

Single pre-exercise ingestion of 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

18 years-old <=

Age-upper limit

25 years-old >=

Gender

Male

Key inclusion criteria

Male healthy distance runner

Key exclusion criteria

1) Subjects receiving treatment (medicine prescription by a doctor)
2) Subjects suffering from serious cardiovascular disorder, liver function disorder, renal dysfunction, respiratory disorder, endocrine disorder, metabolic disorder, or those having history of them
3) Subjects with history of chest pain or fainting.
4) Subjects who are likely to cause allergies related to the test supplement
5) Subjects who donated 200 mL within 1 month prior to the start of the study, or 400 mL (blood donation etc.) within 3 months
6) Smokers
7) Subjects who are judged as unsuitable for this study by physician.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshio Suzuki

Organization

Juntendo University

Division name

Graduate School of Health and Sports Science

Zip code


Address

1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan

TEL

+81-476-98-1001

Email

yssuzuki@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshio Suzuki

Organization

Juntendo University

Division name

Graduate School of Health and Sports Science

Zip code


Address

1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan

TEL

+81-476-98-1001

Homepage URL


Email

yssuzuki@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University, Graduate School of Health and Sports Science

Institute

Department

Personal name



Funding Source

Organization

Juntendo University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Hayashibara Co., Ltd.

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

順天堂大学さくらキャンパス(千葉県)


Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 16 Day


Related information

URL releasing protocol

https://journals.sagepub.com/doi/10.1177/1934578X20933727

Publication of results

Published


Result

URL related to results and publications

https://journals.sagepub.com/doi/10.1177/1934578X20933727

Number of participants that the trial has enrolled

10

Results

Described in the article

Results date posted

2020 Year 07 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 07 Month 28 Day

Baseline Characteristics

Shown as Table 3 in the published article

Participant flow

Shown as Figure 2 in the published article

Adverse events

none

Outcome measures

The mean power and peak pedaling speed

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 09 Month 05 Day

Date of IRB

2017 Year 09 Month 06 Day

Anticipated trial start date

2017 Year 10 Month 18 Day

Last follow-up date

2017 Year 12 Month 12 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 10 Month 16 Day

Last modified on

2020 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033795


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name