UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044494
Receipt number R000050805
Scientific Title Carbohydrate mouth rinse increased plasma dopamine, maintained plasma glucose and improved exercise performance during long-duration high-intensity intermittent exercise
Date of disclosure of the study information 2021/06/10
Last modified on 2021/06/10 16:27:12

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Basic information

Public title

Effect of carbohydrate mouth rinse on ultra-high intensity intermittent exercise performance.

Acronym

Effect of carbohydrate mouth rinse on ultra-high intensity intermittent exercise performance.

Scientific Title

Carbohydrate mouth rinse increased plasma dopamine, maintained plasma glucose and improved exercise performance during long-duration high-intensity intermittent exercise

Scientific Title:Acronym

Carbohydrate mouth rinse increased plasma dopamine, maintained plasma glucose and improved exercise performance during long-duration high-intensity intermittent exercise

Region

Japan


Condition

Condition

healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examines the effect of a carbohydrate mouth rinse on high-intensity intermittent exercise and investigates its relationship to blood hormones.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

catecholamines

Key secondary outcomes

plasma glucose,insulin,cortisol


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Participants received a 6% mouth rinse solution during exercise.Participants performed the same exercise protocol for the control and the mouth rinse, separated by at least one week.

Interventions/Control_2

After 12 hours of fasting, a constant load (CL: 40% VO2peak) was first performed for 60 minutes using a bicycle ergometer, followed by a baseline Wing Rate Test (WT). Then, CL and WT for 30 minutes were repeated three times.

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

23 years-old >=

Gender

Male

Key inclusion criteria

healthy male college student

Key exclusion criteria

students not in good health

Target sample size

8


Research contact person

Name of lead principal investigator

1st name yoko
Middle name
Last name hirata

Organization

Kobe Women's Junior College

Division name

Department of Food and Nutritional Science

Zip code

650-0046

Address

4-7-2 Nakamachi, Minatojima, Chuo-ku, Kobe,

TEL

078-303-4700

Email

yo-hirata@kwjc.kobe-wu.ac.jp


Public contact

Name of contact person

1st name yoko
Middle name
Last name hirata

Organization

Kansai University,

Division name

Faculty of Health and Well-being,

Zip code

590-8815

Address

1-11-1, Kogaoka-cho, Sakai-ku, Sakai, Osaka

TEL

072-229-5022

Homepage URL


Email

yo-hirata@kwjc.kobe-wu.ac.jp


Sponsor or person

Institute

Kansai University

Institute

Department

Personal name



Funding Source

Organization

Kansai University

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

Kansai University

Address

1-11-1,Kogaoka-cho,Sakai-ku,Sakai,Osaka

Tel

072-229-5022

Email

yo-hirata@kwjc.kobe-wu.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

2021 Year 06 Month 10 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

8

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

2018 Year 07 Month 01 Day

Date of IRB

2019 Year 03 Month 11 Day

Anticipated trial start date

2019 Year 03 Month 11 Day

Last follow-up date

2021 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

2021 Year 06 Month 10 Day

Last modified on

2021 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050805


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name