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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023556
Receipt No. R000027129
Scientific Title Blood concentration of plant extract by the intake of beverage containing it (Ex.no.H28-0701)
Date of disclosure of the study information 2017/03/31
Last modified on 2016/10/17

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Basic information
Public title Blood concentration of plant extract by the intake of beverage containing it
(Ex.no.H28-0701)
Acronym Blood concentration of plant extract by the intake of beverage containing it
Scientific Title Blood concentration of plant extract by the intake of beverage containing it
(Ex.no.H28-0701)
Scientific Title:Acronym Blood concentration of plant extract 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 plant extract by the intake of beverage.
Basic objectives2 Pharmacokinetics
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 food containing plant extract
Interventions/Control_2 control food containing plant extract
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 29 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 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jyouji Kurokawa
Organization Iryouhoujinshadanshoureikan Shinsapporo Seiryou Hospital
Division name General Clinical Department
Zip code
Address 1-30, Atsubetsuhigashi4jo, Atsubetsu-ku, Sapporo city, Hokkaido
TEL 011-898-2151
Email seiryo_kurokawa@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soichi Yoneda
Organization QOL RD Co.,Ltd.
Division name CRO Department Food Division
Zip code
Address 2-14-1,Nihonbashi,Chuo-Ku,Tkyo,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
Address
Tel
Email

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 医療法人社団翔嶺館 新札幌聖陵ホスピタル(北海道)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 31 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
2016 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 10 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
2016 Year 08 Month 09 Day
Last modified on
2016 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027129

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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