UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000034283
Receipt No. 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 (Ver. 6)

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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
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, Hiragagakuendai, Inzai, Chiba 270-1695
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 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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039081