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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050129


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name