UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study to evaluate the psychological effects of vinegar beverage
Acronym	A clinical study to evaluate the psychological effects of vinegar beverage
Scientific Title	A clinical study to evaluate the psychological effects of vinegar beverage
Scientific Title:Acronym	A clinical study to evaluate the psychological effects of vinegar beverage
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the psychological effects(refresh, relax) of drinking vinegar beverage
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brain wave (frequency component) Heart rate (HF, LF)
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	Treatment
Type of intervention	Food
Interventions/Control_1	Attach devices(simple type electroencephalograph, simple type electrocardiograph) -> Experimental task(Transcription of voice data for 20 minutes) -> Intake of test food(10 minutes) -> Experimental task(Transcription of voice data for 20 minutes) -> Remove devices
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	The subjects who meet all the conditions in a screening test 1) Healthy people whose age of 20 years or more and less than 65 years old 2) Subjects having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria	1) Subjects having disability of the digestive system 2) Subjects who have the possibility of developing allergic symptoms by the test food 3) Subjects having an abnormality in the electrocardiogram 4) Subjects deemed unsuitable by the investigator
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Hideo Middle name Last name Jingu
Organization	Kanazawa Institute of Technology
Division name	Department of Psychology,Faculty of Information Frontier
Zip code	924-0838
Address	3-1 Yatsukaho, Hakusan, Ishikawa
TEL	076-274-7296
Email	jinguh@neptune.kanazawa-it.ac.jp

Public contact
Name of contact person	1st name Kenta Middle name Last name Hagiwara
Organization	Mizkan Co., Ltd.
Division name	Research and Development Department, Marketing Division
Zip code	475-8585
Address	2-6, Nakamura-cho, Handa, Aichi
TEL	0569-24-5107
Homepage URL
Email	kenta_hagiwara@mizkan.co.jp

Sponsor
Institute	Kanazawa Institute of Technology
Institute
Department

Funding Source
Organization	Mizkan 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	Mizkan Co., Ltd.
Address	2-6, Nakamura-cho, Handa, Aichi
Tel	0569-21-3331
Email	kenta_hagiwara@mizkan.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	2022 Year 07 Month 22 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	10
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	2022 Year 04 Month 26 Day
Date of IRB	2022 Year 05 Month 23 Day
Anticipated trial start date	2022 Year 06 Month 28 Day
Last follow-up date	2022 Year 07 Month 28 Day
Date of closure to data entry	2022 Year 08 Month 31 Day
Date trial data considered complete	2022 Year 08 Month 31 Day
Date analysis concluded	2022 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2022 Year 07 Month 21 Day
Last modified on	2022 Year 11 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054897