UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019196 |
|---|---|
| Receipt number | 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 | 2019/11/08 15:49:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ykhk2525@gmail.com
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022182
