UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034283 |
|---|---|
| Receipt number | R000039081 |
| Scientific Title | Influence of carbohydrate mouth rinse on exercise capacity |
| Date of disclosure of the study information | 2018/09/28 |
| Last modified on | 2020/11/20 11:55:08 |
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Basic information
Public title
Influence of carbohydrate mouth rinse on exercise capacity
Acronym
Influence of carbohydrate mouth rinse on exercise capacity
Scientific Title
Influence of carbohydrate mouth rinse on exercise capacity
Scientific Title:Acronym
Influence of carbohydrate mouth rinse on exercise capacity
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the influence of carbohydrate mouse rinse on exercise capacity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cyclic ergometer
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
Prevention
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
Male healthy distance runner
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
10
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, Hiragagakuendai, Inzai, Chiba 270-1695
TEL
+81476981001
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, Hiragagakuendai, Inzai, Chiba 270-1695
TEL
+81476981001
Homepage URL
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
HAYASHIBARA CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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, Hragagakuendai, Inzai, Chiba 270-1695 Japan
Tel
+81-476-98-1001
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
順天堂大学大学院スポーツ健康科学研究科（千葉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
https://journals.sagepub.com/doi/full/10.1177/1934578X20969594
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/full/10.1177/1934578X20969594
Number of participants that the trial has enrolled
10
Results
A 3-arm double-blind crossover trial was conducted to test this hypothesis. Ten healthy male collegiate distance runners rinsed their mouths with either trehalose (6% w/v) or maltose (6% w/v) or acesulfame potassium (0.04 mg/mL) for 5 seconds and then performed an exercise assessment composed of 6-second peak power and endurance tests. Trehalose induced the highest mean power output (P < .01) in peak power tests.
Results date posted
| 2020 | Year | 11 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://journals.sagepub.com/doi/full/10.1177/1934578X20969594
Participant flow
https://journals.sagepub.com/doi/full/10.1177/1934578X20969594
Adverse events
https://journals.sagepub.com/doi/full/10.1177/1934578X20969594
Outcome measures
https://journals.sagepub.com/doi/full/10.1177/1934578X20969594
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2020 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039081
