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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043636
Receipt No. R000049831
Scientific Title Study evaluating the effect of galvanic tongue stimulation on taste sensation.
Date of disclosure of the study information 2021/03/16
Last modified on 2021/07/06

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Basic information
Public title Study evaluating the effect of galvanic tongue stimulation on taste sensation.
Acronym Study evaluating the effect of galvanic tongue stimulation on taste sensation.
Scientific Title Study evaluating the effect of galvanic tongue stimulation on taste sensation.
Scientific Title:Acronym Study evaluating the effect of galvanic tongue stimulation on taste sensation.
Region
Japan

Condition
Condition No
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to demonstrate the effect of galvanic tongue stimulation on taste sensation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Taste intensity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food Other
Interventions/Control_1 Within 1 day, a participant ingests test food under galvanic tongue stimulation condition. A participant ingests test food under control condition.
Interventions/Control_2
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
65 years-old >=
Gender Male and Female
Key inclusion criteria (1) Male and female subjects aged 20-65 years old who give written informed consent
(2) Give written informed consent, thoroughly understand the study
Key exclusion criteria (1) Have a disease and/or previous history of heart disease, nerve disease and/or brain disease
(2) Have a serious disease of respiratory system
(3) Have an episodic disease such as epilepsia
(4) Wear a device affected by electric field and/or magnetic field
(5) Are pregnant, or are planning to become pregnant
(6) Are sensitive to alcohol
(7) Have allergies
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Homei
Middle name
Last name Miyashita
Organization Meiji University
Division name Faculty of Interdisciplinary Mathematical Sciences
Zip code 1640001
Address 4-21-1, Nakano, Nakano-ku, Tokyo, Japan
TEL 03-5343-8341
Email homei@isc.meiji.ac.jp

Public contact
Name of contact person
1st name Ai
Middle name
Last name Sato
Organization Kirin Holdings Company, Limited
Division name Health Business Strategy Office, Corporate Strategy Department
Zip code 1640001
Address Nakano central South, 4-10-2, Nakano, Nakano-ku, Tokyo
TEL 080-2990-3796
Homepage URL
Email Ai_sato@kirin.co.jp

Sponsor
Institute Meiji University
Institute
Department

Funding Source
Organization Kirin Holdings Company, Limited
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 Research Ethical Review Committee of Kirin Holdings Company, Ltd
Address Nakano central South, 4-10-2, Nakano, Nakano-ku, Tokyo
Tel 03-6837-4128
Email 02976_Ni@kirin.co.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 03 Month 16 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 Open public recruiting
Date of protocol fixation
2020 Year 05 Month 28 Day
Date of IRB
2020 Year 05 Month 28 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 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 03 Month 16 Day
Last modified on
2021 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049831

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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