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

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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

Healthy athletes

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

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

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

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

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

Email

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

Email

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

Email

ethics@med.osaka-cu.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name