UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020582
Receipt No. R000023762
Scientific Title Blood concentration of functional coffee by the intake of beverage containing it.
Date of disclosure of the study information 2016/01/15
Last modified on 2019/08/22 (Ver. 12)

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Basic information
Public title Blood concentration of functional coffee by the intake of beverage containing it.
Acronym Blood concentration of functional coffee by the intake of beverage containing it.
Scientific Title Blood concentration of functional coffee by the intake of beverage containing it.
Scientific Title:Acronym Blood concentration of functional coffee by the intake of beverage containing it.
Region
Japan

Condition
Condition Healthy Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate blood concentration of coffee ingradients after 0, 0.5, 1, 1.5, 2, 5, 9hrs ingestion of functional coffee beverage.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate blood concentration of coffee ingradients after 0, 0.5, 1, 1.5, 2, 5, 9hrs ingestion of functional coffee beverage.
Key secondary outcomes

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 Test coffee containing functional coffee ingredient->3day washout->Control coffee containing nonfunctional coffee ingredient
Interventions/Control_2 Control coffee containing nonfunctional coffee ingredient->3day washout->Test coffee containing functional coffee ingredient
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
60 years-old >
Gender Male
Key inclusion criteria (1) (Healthy) subjects aged 20 to 3559 years old.
(2) Subjects giving written informed consent.
Key exclusion criteria (1) Subjects with serious medical history of hepatic, renal, cardiovascular, respiratory and intestinal disease.
(2) Subjects taking any kind of medicine or supplement which affect the result of the trial for habitual use.
(3) Subjects who might be liable to allergy related to the study
(4) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Motooki
Middle name
Last name Keimatsu
Organization Medical Corporation Hokubukai Utsukushigaoka hospital
Division name Director
Zip code 004-0839
Address 61-1 Shinei Kiyota-ku Sapporo Hokkaido
TEL 011-882-0111
Email utsukushigaoka@hokubu-g.co.jp

Public contact
Name of contact person
1st name Isao
Middle name
Last name Takehara
Organization Clinical Support Corporation
Division name Functional Foods Section
Zip code 060-0061
Address 4-1 South 1 West 8, Chuo-ku, Sapporo Hokkaido
TEL 011-223-3130
Homepage URL
Email takehara@csc-smo.co.jp

Sponsor
Institute Clinical Support Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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 Hokubukai Utsukushigaoka Hospital
Address 61-1, Shinei, Kiyotaku-ku,Sapporo-city, Hokkaido
Tel 011-883-8881
Email utsukushigaoka@hokubu-g.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 株式会社クリニカル・サポート・コーポレーション（北海道）

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 15 Day

Related information
URL releasing protocol Unpublished due to the protocol including the intellectual property rights.
Publication of results Unpublished

Result
URL related to results and publications works in progress
Number of participants that the trial has enrolled 20
Results 
Blood levels were within the expected range.
Results date posted
2019 Year 08 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Healthy men
Participant flow 
20 participants completed and 20 subjects were incorporated into the analyses
Adverse events 
No adverse effect related to the test diets reported
Outcome measures 
Blood concentration of functional coffee ingredients
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 01 Month 14 Day
Date of IRB
2016 Year 02 Month 03 Day
Anticipated trial start date
2016 Year 02 Month 16 Day
Last follow-up date
2016 Year 05 Month 24 Day
Date of closure to data entry
Date trial data considered complete
2016 Year 05 Month 25 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 15 Day
Last modified on
2019 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023762