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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019196
Receipt No. R000022182
Scientific Title A clinical study investigating a possible association between stress and exercise performance with carbohydrate mouth rinse.
Date of disclosure of the study information 2015/10/01
Last modified on 2015/10/05

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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
Middle name
Last name Takahiro Yoshikawa
Organization Osaka City University Graduate School of Medicine
Division name Sports Medicine
Zip code
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
Middle name
Last name Yoko Yamano
Organization Osaka City University Graduate School of Medicine
Division name Sports Medicine
Zip code
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
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
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 Enrolling by invitation
Date of protocol fixation
2015 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 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
2015 Year 10 Month 01 Day
Last modified on
2015 Year 10 Month 05 Day


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

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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