UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035722 |
|---|---|
| Receipt number | R000040693 |
| Scientific Title | A randomized, double-blind, crossover study to examine the effects of concurrent intake of alcohol and test food on cognitive function. |
| Date of disclosure of the study information | 2019/01/30 |
| Last modified on | 2021/02/16 19:16:02 |
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Basic information
Public title
A randomized, double-blind, crossover study to examine the effects of concurrent intake of alcohol and test food on cognitive function.
Acronym
A study examining the effects of concurrent intake of alcohol and test food on cognitive function.
Scientific Title
A randomized, double-blind, crossover study to examine the effects of concurrent intake of alcohol and test food on cognitive function.
Scientific Title:Acronym
A study examining the effects of concurrent intake of alcohol and test food on cognitive function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of concurrent intake of alcohol and test food on cognitive function in adult males.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function score
Key secondary outcomes
Breath measurement,Subjective questionnaire
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 5 tablets of test food.
Interventions/Control_2
Take 5 tablets of placebo.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1.Adult males.
2.Those who consider having a high tolerance to alcohol.
3.Those who drink alcohol more than three times a week.
Key exclusion criteria
1.Those who have an allergy to test food ingredients.
2.Those who have a current or a past medical history of severe disease.
3.Those who are participating in another clinical trial or have participated in another clinical trial within a month.
4.In the opinion of the principal investigator, those who were determined to be unsuitable for participation in this clinical trial.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Okuyama |
Organization
Kewpie Corporation
Division name
Fine Chemicals Department, Institute of Food Creation, R&D Division
Zip code
182-0002
Address
2-5-7 Sengawa cho, Chofu-shi, Tokyo
TEL
03-5384-7766
yohei_okuyama@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Yui/Wei |
| Middle name | |
| Last name | Ou/Wang |
Organization
Kewpie Corporation
Division name
Evaluation & Analysis Sciences Department, Institute of Technology Solutions, R&D Division
Zip code
182-0002
Address
2-5-7 Sengawa cho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
yui_ou@kewpie.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.co.jp
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
| 2019 | Year | 01 | Month | 30 | 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
| 2019 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 30 | Day |
Last modified on
| 2021 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040693
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
