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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020649
Receipt No. R000023828
Scientific Title A study for evaluating the effects of oral intake of alcohol beverages on biological responses. A double-blind, three-way cross-over trial
Date of disclosure of the study information 2016/01/25
Last modified on 2017/07/22

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Basic information
Public title A study for evaluating the effects of oral intake of alcohol beverages on biological responses. A double-blind, three-way cross-over trial
Acronym A study for evaluating the effects of oral intake of alcohol beverages on biological responses
Scientific Title A study for evaluating the effects of oral intake of alcohol beverages on biological responses. A double-blind, three-way cross-over trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Katsuhisa Sakano
Organization CPCC Company, Limited
Division name Department of Parmaceutical Medical Business Sciences
Zip code
Address 3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL 03-5297-3112
Email k.s@cpcc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Numa
Organization CPCC Company, Limited
Division name Sales department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2015 Year 12 Month 16 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023828

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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