UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033192 |
|---|---|
| Receipt number | R000037846 |
| Scientific Title | Pharmacokinetics of mixed polyphenol in healthy humans |
| Date of disclosure of the study information | 2018/07/04 |
| Last modified on | 2019/01/07 13:50:48 |
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Basic information
Public title
Pharmacokinetics of mixed polyphenol in healthy humans
Acronym
Pharmacokinetics of mixed polyphenol in healthy humans
Scientific Title
Pharmacokinetics of mixed polyphenol in healthy humans
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ayame Maihara |
Organization
Kao Corporation
Division name
Safety Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7355
maihara.ayame@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akane Hayashi |
Organization
Kao Corporation
Division name
Safety Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7355
Homepage URL
hayashi.akane@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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 |
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
| 2018 | Year | 06 | Month | 21 | Day |
Date of IRB
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
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 29 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037846
