UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017437 |
|---|---|
| Receipt number | R000019962 |
| Scientific Title | Ethanol decomposition and absorption inhibitory effect confirmation test by Acetobacter intake at the time of drinking |
| Date of disclosure of the study information | 2015/05/10 |
| Last modified on | 2016/08/05 18:58:10 |
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Basic information
Public title
Ethanol decomposition and absorption inhibitory effect confirmation test by Acetobacter intake at the time of drinking
Acronym
The ethanol absorption inhibitor confirmation test by Acetobacter
Scientific Title
Ethanol decomposition and absorption inhibitory effect confirmation test by Acetobacter intake at the time of drinking
Scientific Title:Acronym
The ethanol absorption inhibitor confirmation test by Acetobacter
Region
| Japan |
Condition
Condition
Healthy poeple
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We confirm the alcohol rate of metabolism when taken acetic acid bacterium compounding food with drinking .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We check blood ethanol , blood acetaldehyde , breath in ethanol , blood pressure, then we confirm the alcohol metabolism . And we also ask the alcohol experience survey for subjects.
Key secondary outcomes
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
We take the pre-test blood from subjects and we let them take the lunch meal. Then the subjects take the test food and alcohol for 5minutes after 2hours later from lunch time. The amount of alcohol is body weight per 0.5g / kg and water is 20 percent of the distilled spirits intake . Then We collect blood sampling after 30, 60, 120, 180 minutes. We check the blood ethanol and aldehydes from each blood sample. And we check the breath ethanol concentration and we have them do the experience surveys on each time.
Interventions/Control_2
We take the pre-test blood from subjects and we let them take the lunch meal. Then the subjects take the placebo food and alcohol for 5minutes after 2hours later from lunch time. The amount of alcohol is body weight per 0.5g / kg and water is 20 percent of the distilled spirits intake . Then We collect blood sampling after 30, 60, 120, 180 minutes. We check the blood ethanol and aldehydes from each blood sample. And we check the breath ethanol concentration and we have them do the experience surveys on each time.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
Male.
The person subjectively drinks strong in liquor.
Key exclusion criteria
One during taking medicine, treatment going to hospital.
One with a history of the dangerously ill disease past.
The person who participated in other clinical trials within the past one month.
The person who judged that other examination people in charge were inappropriate.
The person who appeals for poor physical condition on the examination day.
One with much quantity of drinking of the day before.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tanaka |
Organization
Kagawa nutrition university
Division name
Nutrition Clinic
Zip code
Address
3-24-3 Komagome,Toshimaku,Tokyo.
TEL
0339186181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Kamachi |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
Address
3-24-3 Komagome Toshima-ku,Tokyo
TEL
0339186181
Homepage URL
clinic@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corpration
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 10 | 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 | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 03 | 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
| 2015 | Year | 05 | Month | 06 | Day |
Last modified on
| 2016 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019962
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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