UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043146 |
|---|---|
| Receipt number | R000049145 |
| Scientific Title | Effect of Citrate-Containing Foods on Blood Alcohol Concentration. |
| Date of disclosure of the study information | 2021/01/31 |
| Last modified on | 2021/08/02 14:40:10 |
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Basic information
Public title
Effect of Citrate-Containing Foods on Blood Alcohol Concentration - A Randomized Controlled Trial -
Acronym
Effect of Citrate-Containing Foods on Blood Alcohol Concentration - A Randomized Controlled Trial -
Scientific Title
Effect of Citrate-Containing Foods on Blood Alcohol Concentration.
Scientific Title:Acronym
Effect of Citrate-Containing Foods on Blood Alcohol Concentration.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to identify the effects of citrate on reducing the increase in blood levels during alcohol consumption in healthy adult men and women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of efficacy: blood alcohol concentration ,
area under the blood concentration time curve (AUC)
Key secondary outcomes
Evaluation of safety: adverse events
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
YES
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
Pre-inoculate with citrate-containing foods 30 minutes before taking alcohol.
Interventions/Control_2
Pre-inoculation with placebo food 30 minutes before taking alcohol.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese adult males and females
2) Age 20 years or older at the time of consent intake
3) Those with drinking habits
4) Those who have understood the purpose and content of the study and have given their consent.
5) Those who have been judged to have no problem participating in the study
Key exclusion criteria
1) Persons who are intolerant to alcohol
2) Those who are regularly using medicines, food for specified health uses, functional foods, health foods, etc. that may affect the study.
3) Those who are currently participating in other human trials as study subjects, or within 4 weeks of the end of the trial in which they participated.
4) Those with positive test results for hepatitis B, hepatitis C, HIV, or human T-cell leukemia virus.
5) Those who have a history of drug allergy or food allergy.
6) Those who fall under any of the following categories
Those with heart, liver, or kidney disease (including complications from other diseases)
7) Those who have other problems with participation.
8) Those who are pregnant, lactating, or plan to become pregnant during the study period.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Iwahori |
Organization
LLC.okutoeru
Division name
headquarters
Zip code
107-0062
Address
Minamiaoyamasukaihaitsu314 4-18-21 Minamiaoyama, Minato-ku, Tokyo-to 107-0062 Japan
TEL
03-6864-7123
info@okutoeru.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Iwahori |
Organization
LLC.okutoeru
Division name
headquarters
Zip code
107-0062
Address
Minamiaoyamasukaihaitsu314 4-18-21 Minamiaoyama, Minato-ku, Tokyo-to 107-0062 Japan
TEL
03-6864-7123
Homepage URL
info@okutoeru.com
Sponsor or person
Institute
LLC.okutoeru
Nihon Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-profit organization OFFICE SHI-YOU (Ethics Review Committee)
Address
Minamiaoyamasukaihaitsu314 4-18-21 Minamiaoyama, Minato-ku, Tokyo-to 107-0062 Japan
Tel
03-6864-7123
info@okutoeru.com
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
| 2021 | Year | 01 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2021 | Year | 01 | Month | 27 | Day |
Last modified on
| 2021 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049145
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
