UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043896 |
|---|---|
| Receipt number | R000050129 |
| Scientific Title | The pharmacokinetic study of co-administration of polyphenols |
| Date of disclosure of the study information | 2021/04/20 |
| Last modified on | 2021/04/12 13:40:03 |
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Basic information
Public title
The pharmacokinetic study of co-administration of polyphenols
Acronym
The pharmacokinetic study of co-administration of polyphenols
Scientific Title
The pharmacokinetic study of co-administration of polyphenols
Scientific Title:Acronym
The pharmacokinetic study of co-administration of polyphenols
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 when polyphenols were
co-administrated in healthy human
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma and urinal concentration of polyphenols and their
metabolites
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Polyphenol beverage was administrated. After the 5-9 day washout period, the subject received a polyphenol-containing beverage and polyphenol supplement in the same manner. Venous blood samples were collected exactly 0.5, 1, 2, 4, 6, 8 h after administration. Urinal samples were collected for 8 hours after administration.
Interventions/Control_2
Polyphenol beverage and quercetin supplement were coadministrated.After the 5-9 day washout period, the subject received a polyphenol-containing beverage in the same manner. Venous blood samples were collected exactly 0.5, 1, 2, 4, 6, 8 h after administration. Urinal samples were collected for 8 hours after administration.
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
13
Research contact person
Name of lead principal investigator
| 1st name | Naohiro |
| Middle name | |
| Last name | Ikeda |
Organization
Kao Corporation
Division name
Safety Science Research
Zip code
210-0821
Address
Innovation Center of NanoMedicine 2108, 3-25-14, Otod omachi, Kawasaki ku, Kawasaki City, Kanagawa Prefect ure
TEL
080-8763-1214
ikeda.naohiro@kao.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Kikuchi |
Organization
Kao Corporation
Division name
Safety Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3 497, JAPAN
TEL
070-3301-1653
Homepage URL
kikuchi.takuya@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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 20 | 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
9
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
| 2019 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 12 | Day |
Last modified on
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050129
