UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ethanol decomposition and absorption inhibitory effect confirmation test by Acetobacter intake at the time of drinking
Title of the study (Brief title)	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	Akira Tanaka
Organization	Kagawa nutrition university
Division name	Nutrition Clinic
Address	3-24-3 Komagome,Toshimaku,Tokyo.
TEL	0339186181
Email	clinic@eiyo.ac.jp

Public contact
Name of contact person	Keiko Kamachi
Organization	Kagawa Nutrition University
Division name	Nutrition Clinic
Address	3-24-3 Komagome Toshima-ku,Tokyo
TEL	0339186181
Homepage URL
Email	clinic@eiyo.ac.jp

Sponsor
Institute	Kagawa Nutrition University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019962