UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Toshiyuki Sasaguri
Organization	Faculty of Medical Science, Kyushu University
Division name	Department of Clinical Pharmacology
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	+81-92-642-6082
Email	sasaguri@clipharm.med.kyushu-u.ac.jp

Public contact
Name of contact person	Tatsuya Yoshihara
Organization	Faculty of Medical Sciences, Kyushu University
Division name	Department of Clinical Pharmacology
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	+81-92-642-6082
Homepage URL
Email	tatsuya@clipharm.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Clinical Pharmacology, Faculty of Medical Science, Kyushu University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012118