UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010360 |
|---|---|
| Receipt number | R000012118 |
| Scientific Title | Influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on mental calculations, blood pressure and pulse rate after intake of caffeine: a double-blind randomized placebo-controlled clinical trial. |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2017/09/19 17:06:33 |
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Basic information
Public title
Influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on mental calculations, blood pressure and pulse rate after intake of caffeine: a double-blind randomized placebo-controlled clinical trial.
Acronym
Influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on the effect of caffeine
Scientific Title
Influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on mental calculations, blood pressure and pulse rate after intake of caffeine: a double-blind randomized placebo-controlled clinical trial.
Scientific Title:Acronym
Influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on the effect of caffeine
Region
| Japan |
Condition
Condition
Effect of caffeine
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To reveal the influence of polymorphisms of adenosine A2 receptor and dopamine D2 receptor on effect of caffeine 200 mg on mental calculation ability, blood pressure and pulse rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of the accurate number of mental calculation after intake caffeine 200 mg compared to decafe
Key secondary outcomes
Change of blood pressure and pulse rate after intake caffeine 200 mg compared to decafe
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intake coffee 150 mL with caffeine 200mg
Interventions/Control_2
intake coffee 150 mL without caffeine
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 and Female
Key inclusion criteria
Healthy adult volunteers
Key exclusion criteria
1. cardiovascular disease that should be treated
2. severe liver disease
3. severe renal disease
4. pregnant women and women suspected of being pregnant
5. severe allergic reaction and allergic reaction to caffeine
6. gastric ulcer
7. glaucoma
8. On medical treatment
9. Not appropriate to this study by other reasons
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Sasaguri |
Organization
Faculty of Medical Science, Kyushu University
Division name
Department of Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
+81-92-642-6082
sasaguri@clipharm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yoshihara |
Organization
Faculty of Medical Sciences, Kyushu University
Division name
Department of Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
+81-92-642-6082
Homepage URL
tatsuya@clipharm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology, Faculty of Medical Science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | 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
| 2013 | Year | 03 | Month | 29 | Day |
Last modified on
| 2017 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012118
