UMIN-CTR Clinical Trial

Basic information
Public title	Evaluating the Mental Status of the Effects of Specific Beverage Interventions on Humans
Acronym	Evaluating the Mental Status of the Effects of Specific Beverage Interventions on Humans
Scientific Title	Evaluating the Mental Status of the Effects of Specific Beverage Interventions on Humans
Scientific Title:Acronym	Evaluating the Mental Status of the Effects of Specific Beverage Interventions on Humans
Region	Japan

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

Objectives
Narrative objectives1	Investigate mental state before and after ingestion of the beverage
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Mental state questionnaire (Likert scale)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	A single 50ml intake of test drink 1
Interventions/Control_2	A single 50ml intake of test drink 2
Interventions/Control_3	A single 50ml intake of test drink 3
Interventions/Control_4	A single 50ml intake of test drink 4
Interventions/Control_5	A single 50ml intake of test drink 5
Interventions/Control_6	A single 50ml intake of placebo drink
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.Japanese men and women aged between 20 and 65 at the time of informed consent. 2.Those who can visit the designated office and fill in the records 3.No stuffy nose 4.Able to distinguish scent 5.Those who have received a sufficient explanation of the purpose and content of the study and have given written consent to participate voluntarily.
Key exclusion criteria	1.Those who don't like the smell of coffee 2.Those who have or are aware of an olfactory impairment 3.Those with symptoms of rhinitis 4.Those suffering from serious illness 5.Those who are pregnant or breastfeeding 6.Irregular lifestyle 7.hose who have participated in other clinical trials or clinical trials within the last month
Target sample size	12

Research contact person
Name of lead principal investigator	1st name soichi Middle name Last name yoneda
Organization	Mibyou Life Science inc
Division name	Clinical Trials Division
Zip code	1010061
Address	2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
TEL	03-6256-9600
Email	renraku@mibyou-ls.com

Public contact
Name of contact person	1st name soichi Middle name Last name yoneda
Organization	Mibyou Life Science inc
Division name	Clinical Trials Division
Zip code	1010061
Address	2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
TEL	03-6256-9600
Homepage URL
Email	renraku@mibyou-ls.com

Sponsor
Institute	Mibyou Life Science inc
Institute
Department

Funding Source
Organization	Mibyou Life Science inc
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	Mibyou Research Ethics Review Committee
Address	2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
Tel	03-6272-9163
Email	renraku@npo-mibyou.com

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 08 Month 25 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	2022 Year 08 Month 17 Day
Date of IRB	2022 Year 08 Month 23 Day
Anticipated trial start date	2022 Year 08 Month 25 Day
Last follow-up date	2022 Year 10 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	2022 Year 08 Month 25 Day
Last modified on	2022 Year 11 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055546