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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039081


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name