UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018400 |
|---|---|
| Receipt number | R000021279 |
| Scientific Title | The investigation of indices representing Stress/Relax induced by Alcohol -1- |
| Date of disclosure of the study information | 2015/07/24 |
| Last modified on | 2016/07/20 14:23:11 |
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Basic information
Public title
The investigation of indices representing Stress/Relax induced by Alcohol -1-
Acronym
The investigation of indices representing Stress/Relax induced by Alcohol -1-
Scientific Title
The investigation of indices representing Stress/Relax induced by Alcohol -1-
Scientific Title:Acronym
The investigation of indices representing Stress/Relax induced by Alcohol -1-
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the appropriate measures of relax induced by alcohol
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective evaluations (General Emotion Scale, Intoxication, Sleepiness, Comfort) and physiological measures (EEG, Heart Rate, Electro Dermal Activity, Cortisol, CgA, IgA, facial expressions, breath ethanol)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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
Taking alcohol->Tanking no alcohol
Interventions/Control_2
Tanking no alcohol->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
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
1) BMI>=18.5 kg/m2, <25 kg/ m2
2) Non flusher
Key exclusion criteria
1) Person with Systolic blood pressure under 90 mmHg
2) Person with heart disease, liver disease, kidney disease
3) Person with medical history of circulatory disease
4) Person with diabetes
5) Person with drug and/or food allergy
6) Alcoholic person (KAST-M score over 4)
7) Person with depression or anxiety disorder
8) Person who the doctor assessed as improper
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Nakamura |
Organization
Suntory Global Innovation Center Limited
Division name
Research Institute
Zip code
Address
Suntory World Research Center 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
050-3182-0460
Junichi_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyuki Matsuzaki |
Organization
Suntory Global Innovation Center Limited
Division name
Research Institute
Zip code
Address
Suntory World Research Center 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
050-3182-0570
Homepage URL
Naoyuki_Matsuzaki@suntory.co.jp
Sponsor or person
Institute
Centan Inc.
Institute
Department
Personal name
Funding Source
Organization
Suntory Spirits 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 24 | 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 | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 23 | Day |
Last modified on
| 2016 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021279
