UMIN-CTR Clinical Trial

Basic information
Public title	Effect of carbohydrate mouth rinse on jump performance
Acronym	Effect of carbohydrate mouth rinse on jump performance
Scientific Title	Effect of carbohydrate mouth rinse on jump performance
Scientific Title:Acronym	Effect of carbohydrate mouth rinse on jump performance
Region	Japan

Condition
Condition	Healthy subject
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of carbohydrate mouth rinse on jump performance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	jump performance
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are 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	Pre-exercise mouth rinse of a disaccharide
Interventions/Control_2	Pre-exercise mouth rinse of another disaccharide
Interventions/Control_3	Pre-exercise mouth rinse of sweetened non-caloric 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	Healthy male jumper
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
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Yoshio Middle name Last name Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Zip code	270-1695
Address	1-1, Hiragagakuenndai, Inzai, Chiba
TEL	+81476981001
Email	yssuzuki@juntendo.ac.jp

Public contact
Name of contact person	1st name Yoshio Middle name Last name Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Zip code	270-1695
Address	1-1, Hiragagakuenndai, Inzai, Chiba
TEL	+81476981001
Homepage URL
Email	yssuzuki@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	HAYASHIBARA CO., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee of Juntendo University Graduate School of Sports and Health Science
Address	1-1, Hiragagakuendai, Inzai, Chiba 270-1695
Tel	+81476981001
Email	sc-kyomu@juntendo.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	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	2019 Year 06 Month 11 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 09 Month 11 Day
Date of IRB	2018 Year 09 Month 11 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2020 Year 03 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	2019 Year 06 Month 10 Day
Last modified on	2020 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042167