UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020649 |
|---|---|
| Receipt number | 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 18:16:34 |
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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
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
m.n@cpcc.co.jp
Sponsor or person
Institute
CPCC Company, Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023828
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