UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035067
Receipt number R000039975
Scientific Title Effect of pre-exercise glucose ingestion on insulin shock and endurance exercise performance in student athletes
Date of disclosure of the study information 2018/11/29
Last modified on 2018/11/29 13:11:38

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Basic information

Public title

Effect of pre-exercise glucose ingestion on insulin shock and endurance exercise performance in student athletes

Acronym

Effect of pre-exercise glucose ingestion on insulin shock and endurance exercise performance in student athletes

Scientific Title

Effect of pre-exercise glucose ingestion on insulin shock and endurance exercise performance in student athletes

Scientific Title:Acronym

Effect of pre-exercise glucose ingestion on insulin shock and endurance exercise performance in student athletes

Region

Japan


Condition

Condition

Healthy

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of pre-exercise glucose ingestion on insulin shock and endurance exercise performance in Japanese student athletes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

blood glucose level

Key secondary outcomes

rate of perceived exertion, time of exercise to exhaustion, VO2, VCO2, carbohydrate oxidation, fat oxidation


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

1) intake of dietetic food for dinner
2) intake of dietetic food for breakfast
3) intake of glucose
4) pre-exercise measurement
5) exercise and during-exercise measurement
6) post-exercise measurement

Interventions/Control_2

1) intake of dietetic food for dinner
2) intake of dietetic food for breakfast
3) intake of placebo
4) pre-exercise measurement
5) exercise and during-exercise measurement
6) post-exercise measurement

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

22 years-old >=

Gender

Male

Key inclusion criteria

Japanese healthy male students at Kanazawa University who are members of the university athletic club

Key exclusion criteria

Subjects who take medicines or supplements for treatment of blood glucose level

Target sample size

9


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoko Terasawa

Organization

Kanazawa University

Division name

Faculty of Human Science

Zip code


Address

Kakuma, Kanazawa

TEL

076-264-5484

Email

terasawa@staff.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoko Terasawa

Organization

Kanazawa University

Division name

Faculty of Human Science

Zip code


Address

Kakuma, Kanazawa

TEL

076-264-5484

Homepage URL


Email

terasawa@staff.kanazawa-u.ac.jp


Sponsor or person

Institute

kanazawa University

Institute

Department

Personal name



Funding Source

Organization

Kanazawa University

Organization

Division

Category of Funding Organization

Other

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

2018 Year 11 Month 29 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

Completed

Date of protocol fixation

2018 Year 08 Month 28 Day

Date of IRB


Anticipated trial start date

2018 Year 08 Month 28 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

2018 Year 11 Month 29 Day

Last modified on

2018 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=R000039975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name