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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033192
Receipt No. R000037846
Official scientific title of the study Pharmacokinetics of mixed polyphenol in healthy humans
Date of disclosure of the study information 2018/07/04
Last modified on 2018/07/12

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Basic information
Official scientific title of the study Pharmacokinetics of mixed polyphenol in healthy humans
Title of the study (Brief title) Pharmacokinetics of mixed polyphenol in healthy humans
Region
Japan

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

Objectives
Narrative objectives1 To understand pharmacokinetics of polyphenol when healthy human ingest two kinds of polyphenol
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics and metabolism of ingested polyphenols
Key secondary outcomes Blood and urine analysis to evaluate liver and kidney function

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingest the control drinks twice a day. After 1 week washout period, ingest the experimental drinks which include polyphenols twice a day.
Interventions/Control_2
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
59 years-old >=
Gender Male
Key inclusion criteria Healthy males
Key exclusion criteria -Subjects with drug or food allergies, severe anemia
-Subjects with gastrointestinal, renal, cardiovascular, or hepatic disease
- Subjects with metabolic disease
- Subjects with medical history of drug or alcohol dependence
- Subjects who donated blood in 12 weeks
- Smoker
- Subjects who have difficulties in collecting blood
- Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 20

Research contact person
Name of lead principal investigator Ayame Maihara
Organization Kao Corporation
Division name Safety Science Research
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7355
Email maihara.ayame@kao.com

Public contact
Name of contact person Akane Hayashi
Organization Kao Corporation
Division name Safety Science Research
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7355
Homepage URL
Email hayashi.akane@kao.com

Sponsor
Institute Kao 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)

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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 04 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 21 Day
Anticipated trial start date
2018 Year 06 Month 21 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 Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 29 Day
Last modified on
2018 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037846

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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