UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023281
Receipt No. R000026839
Scientific Title Blood concentration of functional coffee by the intake of beverage containing it.
Date of disclosure of the study information 2016/08/01
Last modified on 2019/08/22 (Ver. 10)

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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 beverage.
Scientific Title Blood concentration of functional coffee by the intake of beverage containing it.
Scientific Title:Acronym Blood concentration of functional coffee beverage.
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 functional coffee by the intake of beverage.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood concentration after the intake of 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 Active
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
Interventions/Control_2 Control 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
30 years-old >
Gender Male
Key inclusion criteria (1) (Healthy) subjects aged 20 to 30 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 25

Research contact person
Name of lead principal investigator
1st name Kazuhiko
Middle name
Last name Fujisawa
Organization Ageokousei hospital
Division name Director
Zip code 362-0051
Address 421-1,Jitogata, Ageo, Saitama,Japan
TEL 048-781-1101
Email masayuki.nakamura@achs.jp

Public contact
Name of contact person
1st name Soichi
Middle name
Last name Yoneda
Organization QOL RD Co.,Ltd.
Division name CRO Department Food Division
Zip code 103-0027
Address 2-14-1,Nihonbashi,Chuo-Ku,Tokyo,Japan
TEL 03-6386-8809
Homepage URL
Email s-yoneda@qol-rd.co.jp

Sponsor
Institute QOL RD Co.,Ltd.
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 Ageokousei hospital IRB
Address 421-1 JItoukata Ageo city Saitama Prefecture
Tel 048-781-1101
Email masayuki.nakamura@achs.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 上尾甦生病院（埼玉県）

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 01 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 23
Results 
Blood levels were within the expected range.
Results date posted
2019 Year 08 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Healthy men
Participant flow 
23 participants completed and 23 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 07 Month 04 Day
Date of IRB
2016 Year 07 Month 04 Day
Anticipated trial start date
2016 Year 08 Month 07 Day
Last follow-up date
2016 Year 10 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 22 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=R000026839