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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044494
Receipt No. R000050805
Scientific Title Carbohydrate mouth rinse increased plasma dopamine, maintained plasma glucose and improved exercise performance during long-duration high-intensity intermittent exercise
Date of disclosure of the study information 2021/06/10
Last modified on 2021/06/10

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Basic information
Public title Effect of carbohydrate mouth rinse on ultra-high intensity intermittent exercise performance.
Acronym Effect of carbohydrate mouth rinse on ultra-high intensity intermittent exercise performance.
Scientific Title Carbohydrate mouth rinse increased plasma dopamine, maintained plasma glucose and improved exercise performance during long-duration high-intensity intermittent exercise
Scientific Title:Acronym Carbohydrate mouth rinse increased plasma dopamine, maintained plasma glucose and improved exercise performance during long-duration high-intensity intermittent exercise
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examines the effect of a carbohydrate mouth rinse on high-intensity intermittent exercise and investigates its relationship to blood hormones.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes catecholamines
Key secondary outcomes plasma glucose,insulin,cortisol

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Participants received a 6% mouth rinse solution during exercise.Participants performed the same exercise protocol for the control and the mouth rinse, separated by at least one week.
Interventions/Control_2 After 12 hours of fasting, a constant load (CL: 40% VO2peak) was first performed for 60 minutes using a bicycle ergometer, followed by a baseline Wing Rate Test (WT). Then, CL and WT for 30 minutes were repeated three times.
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
23 years-old >=
Gender Male
Key inclusion criteria healthy male college student
Key exclusion criteria students not in good health
Target sample size 8

Research contact person
Name of lead principal investigator
1st name yoko
Middle name
Last name hirata
Organization Kobe Women's Junior College
Division name Department of Food and Nutritional Science
Zip code 650-0046
Address 4-7-2 Nakamachi, Minatojima, Chuo-ku, Kobe,
TEL 078-303-4700
Email yo-hirata@kwjc.kobe-wu.ac.jp

Public contact
Name of contact person
1st name yoko
Middle name
Last name hirata
Organization Kansai University,
Division name Faculty of Health and Well-being,
Zip code 590-8815
Address 1-11-1, Kogaoka-cho, Sakai-ku, Sakai, Osaka
TEL 072-229-5022
Homepage URL
Email yo-hirata@kwjc.kobe-wu.ac.jp

Sponsor
Institute Kansai University
Institute
Department

Funding Source
Organization Kansai 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 Kansai University
Address 1-11-1,Kogaoka-cho,Sakai-ku,Sakai,Osaka
Tel 072-229-5022
Email yo-hirata@kwjc.kobe-wu.ac.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
2021 Year 06 Month 10 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 8
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 07 Month 01 Day
Date of IRB
2019 Year 03 Month 11 Day
Anticipated trial start date
2019 Year 03 Month 11 Day
Last follow-up date
2021 Year 01 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
2021 Year 06 Month 10 Day
Last modified on
2021 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050805

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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