UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023150
Receipt No. R000026688
Scientific Title Blood concentration of plant extract by the intake of beverage containing it (Ex.no.H28-0524)
Date of disclosure of the study information 2017/03/31
Last modified on 2020/03/31 (Ver. 7)

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Basic information
Public title Blood concentration of plant extract by the intake of beverage containing it
(Ex.no.H28-0524)
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.H28-0524)
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
60 years-old >
Gender Male
Key inclusion criteria (1) (Healthy) subjects aged 20 to 59 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 Masaki
Middle name
Last name Nishiyama
Organization Kaiyu Clinic
Division name Doctor
Zip code 165-0032
Address 3-3-6 Sagimiya, Nakano-ku, Tokyo
TEL 03-5356-6450
Email abe@kaiyuclinic.com

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,Tkyo,
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 Kanazawa Bunko Hospital IRB
Address 2-6-22, Kamariya Higashi, Kanazawa-ku, Yokohama
Tel 045-785-3311
Email nagashima@kanabun-hp.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 カイユウ診療所（東京都）

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 31 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 27
Results 
Blood levels were within the expected range.
Results date posted
2020 Year 03 Month 31 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Healthy men
Participant flow 
21 participants completed and 21 subjects were incorporated into the analyses
Adverse events 
No adverse effect related to the test diets reported
Outcome measures 
Blood concentration of ingredients
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 20 Day
Date of IRB
2016 Year 06 Month 20 Day
Anticipated trial start date
2016 Year 07 Month 11 Day
Last follow-up date
2016 Year 09 Month 05 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 13 Day
Last modified on
2020 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026688