UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation of indices representing Stress/Relax induced by Alcohol -1-
Title of the study (Brief title)	The investigation of indices representing Stress/Relax induced by Alcohol -1-
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the appropriate measures of relax induced by alcohol
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective evaluations (General Emotion Scale, Intoxication, Sleepiness, Comfort) and physiological measures (EEG, Heart Rate, Electro Dermal Activity, Cortisol, CgA, IgA, facial expressions, breath ethanol)
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	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	Prevention
Type of intervention	Food
Interventions/Control_1	Taking alcohol->Tanking no alcohol
Interventions/Control_2	Tanking no alcohol->Taking alcohol
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	50 years-old >=
Gender	Male
Key inclusion criteria	1) BMI>=18.5 kg/m2, <25 kg/ m2 2) Non flusher
Key exclusion criteria	1) Person with Systolic blood pressure under 90 mmHg 2) Person with heart disease, liver disease, kidney disease 3) Person with medical history of circulatory disease 4) Person with diabetes 5) Person with drug and/or food allergy 6) Alcoholic person (KAST-M score over 4) 7) Person with depression or anxiety disorder 8) Person who the doctor assessed as improper
Target sample size	20

Research contact person
Name of lead principal investigator	Junichi Nakamura
Organization	Suntory Global Innovation Center Limited
Division name	Research Institute
Address	Suntory World Research Center 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL	050-3182-0460
Email	Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person	Naoyuki Matsuzaki
Organization	Suntory Global Innovation Center Limited
Division name	Research Institute
Address	Suntory World Research Center 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL	050-3182-0570
Homepage URL
Email	Naoyuki_Matsuzaki@suntory.co.jp

Sponsor
Institute	Centan Inc.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Suntory Spirits Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 07 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 14 Day
Anticipated trial start date	2015 Year 07 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 23 Day
Last modified on	2016 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021279