UMIN-CTR Clinical Trial

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
Email	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
Email	kikuchi.takuya@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)

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050129