UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effects of oral intake of alcohol beverages on biological responses. A double-blind, three-way cross-over trial
Title of the study (Brief title)	A study for evaluating the effects of oral intake of alcohol beverages on biological responses
Region	Japan

Condition
Condition	None (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy of oral intake of alcohol beverages on biological responses
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of physiological measures including breath ethanol, indexes of autonomic and central nervous systems for one hour after intervenstion
Key secondary outcomes	Evaluation of emotions using questionnaire survey for one hour after intervenstion

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved 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	One sample is taken and biological responses are measured every day for 3 straight days. 5% alcohol (day 1), 3% alcohol (day 2), 0% alcohol (day 3) in order.
Interventions/Control_2	One sample is taken and biological responses are measured every day for 3 straight days. 5% alcohol (day 1), 0% alcohol (day 2), 3% alcohol (day 3) in order.
Interventions/Control_3	One sample is taken and biological responses are measured every day for 3 straight days. 3% alcohol (day 1), 5% alcohol (day 2), 0% alcohol (day 3) in order.
Interventions/Control_4	One sample is taken and biological responses are measured every day for 3 straight days. 3% alcohol (day 1), 0% alcohol (day 2), 5% alcohol (day 3) in order.
Interventions/Control_5	One sample is taken and biological responses are measured every day for 3 straight days. 0% alcohol (day 1), 5% alcohol (day 2), 3% alcohol (day 3) in order.
Interventions/Control_6	One sample is taken and biological responses are measured every day for 3 straight days. 0% alcohol (day 1), 3% alcohol (day 2), 5% alcohol (day 3) in order.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	30 years-old >
Gender	Male
Key inclusion criteria	1)Males aged from 20 to less than 30 years old and weighted from 58 kilograms to less than 72 kilograms, when giving the informed consent. 2)Individuals who can drink and does not dislike chuhai. 3)Individuals who show NN (normal/normal) or ND (normal/deficient) in the alcohol patchtest 4)Individuals whose biological responses can be suitably measured. 5)Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
Key exclusion criteria	1)Individuals who cannot drink alcohol beverages and / or have alcohol allergy. 2)Individuals who cannot stop drinking alcohol beverages the day before the checkup except for the test beverages during this study. 3)Individuals who use medicines which have possible effects on mental condition continuously. 4)Individuals who have under treatment or a history of drug addiction and / or alcoholism. 5)Individuals who have a history of mental diseases and / or epilepsy. 6)Individuals who have a plan to drive a car and operate a machine. 7)Individuals who have drug and / or food allergy. 8)Individuals who are participating in other clinical trials of drugs or health food, who participated in the last 4 weeks, or who are willing to participate after giving the informed consent. 9)Individuals who have a smoking habit. 10)Individuals who are judged unsuitable for this study by the investigators for other reasons.
Target sample size	36

Research contact person
Name of lead principal investigator	Katsuhisa Sakano
Organization	CPCC Company, Limited
Division name	Department of Parmaceutical Medical Business Sciences
Address	3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL	03-5297-3112
Email	k.s@cpcc.co.jp

Public contact
Name of contact person	Masanori Numa
Organization	CPCC Company, Limited
Division name	Sales department
Address	3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL	03-5297-3112
Homepage URL
Email	m.n@cpcc.co.jp

Sponsor
Institute	CPCC Company, Limited
Institute
Department

Funding Source
Organization	Kirin Company, 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	ＣＰＣＣ株式会社／CPCC Company, Limited

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 16 Day
Anticipated trial start date	2016 Year 01 Month 28 Day
Last follow-up date	2016 Year 04 Month 30 Day
Date of closure to data entry	2016 Year 06 Month 30 Day
Date trial data considered complete	2016 Year 09 Month 30 Day
Date analysis concluded	2016 Year 09 Month 30 Day

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

Management information
Registered date	2016 Year 01 Month 20 Day
Last modified on	2017 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023828