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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042324
Receipt No. R000048314
Scientific Title Physiological influence of carbohydrate mouth rinse
Date of disclosure of the study information 2020/11/02
Last modified on 2021/05/03

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Basic information
Public title Physiological influence of carbohydrate mouth rinse
Acronym Physiological influence of carbohydrate mouth rinse
Scientific Title Physiological influence of carbohydrate mouth rinse
Scientific Title:Acronym Physiological influence of carbohydrate mouth rinse
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 effect of carbohydrate mouth rinse on brain activity
Basic objectives2 Others
Basic objectives -Others To examine by functional MRI
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Brain activity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 Disaccharide, mouth rinse/Water, mouth rinse
Interventions/Control_2 Another disaccharide, mouth rinse/Water, mouth rinse
Interventions/Control_3 Acesulfame K, mouth rinse/Water, mouth rinse
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 1) Healthy
2) Athlete belonging to a collegiate athletic club
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 Suzuki
Last name Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code 2701695
Address 1-1, Hiragagakuenndai, Inzai, Chiba
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 2701695
Address 1-1, Hiragagakuenndai, Inzai, Chiba
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

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, Hiragagakuendai, Inzai, Chiba 270-1695
Tel +81476981001
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 AIC八重洲クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 02 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
2020 Year 07 Month 14 Day
Date of IRB
2020 Year 07 Month 14 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 02 Day
Last modified on
2021 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048314

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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