UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study investigating a possible association between stress and exercise performance with carbohydrate mouth rinse.
Acronym	A possible association between stress and exercise performance with carbohydrate mouth rinse.
Scientific Title	A clinical study investigating a possible association between stress and exercise performance with carbohydrate mouth rinse.
Scientific Title:Acronym	A possible association between stress and exercise performance with carbohydrate mouth rinse.
Region	Japan

Condition
Condition	Healthy athletes
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of ergometer exercise with carbohydrate mouth rinse on exercise performance and endocrine system.
Basic objectives2	Others
Basic objectives -Others	To investigate the association of carbohydrate mouth rinse with exercise performance and endocrine system.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Performance time completing the target energy expenditure of exercise.
Key secondary outcomes	Height, body weight, body mass index (BMI), body composition, erythrocytes, hemoglobin, hematocrit, thrombocytes, blood glucose, insulin, lactic acid, cortisol, catecholamine, interleukin-6, blood pressure, heart rate, and rating of perceived exertion(RPE)

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	All exercise tests are carried out on a cycle ergometer. The protocol consists of four visits. The first visit is an incremental exercise test to exhaustion to determine the maximal power output (Wmax) of each volunteer, and to calculate a set amount of energy expenditure for the main experiments (time trials) on the third and fourth visits according to the formula: The set amount of energy expenditure = 0.75*Wmax*3600. On the second visit, an exercise practice is performed in order to familiarize the time trial and to confirm that volunteers can complete the set amount of energy expenditure. On the third visit, the time trial is performed. After 5-min warm-up (100W), the volunteers are asked to complete the set amount of energy expenditure in the shortest time possible. During the exercise, the volunteers are given a 25ml bolus of 6% maltodextrin solution to rinse their mouth for approximately 5 seconds for every 12.5% of the time trial completed including the timing before and after the warm-up. On the fourth visit, the same time trial with the same mouth rinse protocol is performed using a placebo (water) instead of maltodextrin solution. Each visit is separated by more than 2 days.
Interventions/Control_2	All exercise tests are carried out on a cycle ergometer. The protocol consists of four visits. The first visit is an incremental exercise test to exhaustion to determine the maximal power output (Wmax) of each volunteer, and to calculate a set amount of energy expenditure for the main experiments (time trials) on the third and fourth visits according to the formula: The set amount of energy expenditure = 0.75*Wmax*3600. On the second visit, an exercise practice is performed in order to familiarize the time trial and to confirm that volunteers can complete the set amount of energy expenditure. On the third visit, the time trial is performed. After 5-min warm-up (100W), the volunteers are asked to complete the set amount of energy expenditure in the shortest time possible. During the exercise, the volunteers are given a 25ml bolus of a placebo (water) instead of maltodextrin solution to rinse their mouth for approximately 5 seconds for every 12.5% of the time trial completed including the timing before and after the warm-up. On the fourth visit, the same time trial with the same mouth rinse protocol is performed using 6% maltodextrin solution. Each visit is separated by more than 2 days.
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	35 years-old >=
Gender	Male
Key inclusion criteria	Healthy male cyclists
Key exclusion criteria	Participants with past or current history of cardiovascular diseases, metabolic diseases, and/or other severe diseases. Participants with common cold and/or any current medication. Participants with any special diet and who are judged as unsuitable for participation in this study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Yoshikawa
Organization	Osaka City University Graduate School of Medicine
Division name	Sports Medicine
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585
TEL	06-6645-3790
Email	tkhr6719@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Yamano
Organization	Osaka City University Graduate School of Medicine
Division name	Sports Medicine
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585
TEL	06-6645-3790
Homepage URL
Email	ykhk2525@gmail.com

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
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	The Ethics Committee of Osaka City University Graduate School of Medicine
Address	1-2-7, Asahi-machi, Abeno-ku, Osaka, 545-8533
Tel	06-6645-3435
Email	ethics@med.osaka-cu.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	2015 Year 10 Month 01 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	2015 Year 09 Month 29 Day
Date of IRB	2015 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2016 Year 08 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 01 Day
Last modified on	2019 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022182