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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035067
Receipt No. 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

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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
Institute kanazawa University
Institute
Department

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
URL(English) https://upload.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


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