UMIN-ICDS Clinical Trial

Public title

Pilot study on pharmacokinetics of tea ingredients

Acronym

Pharmacokinetic study of tea ingredients

Scientific Title

Pilot study on pharmacokinetics of tea ingredients

Scientific Title:Acronym

Pharmacokinetic study of tea-derived ingredients

Region

Japan

Condition

healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Examine how much the polyphenol component of ingested tea is transferred to the blood and saliva.

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Blood concentration and saliva concentration of tea polyphenols

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

After obtaining consent from the subjects, the subjects were randomly selected to ingest one of tea candy 1, tea candy 2, or placebo candy, and blood and saliva were collected immediately after, 1 hour, and 2 hours after ingestion (first day of the test).

Interventions/Control_2

At least 24 hours later, the subjects were asked to ingest another type of candy, and blood and saliva were collected immediately, 1 hour, and 2 hours after ingestion (second day of the test).

Interventions/Control_3

After another 24 hours or more, the subjects were asked to ingest another type of candy, and blood and saliva were collected immediately, 1 hour, and 2 hours after ingestion (3rd day of the test).

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Healthy adult men and women with no subjective symptoms
2.Those who can obtain written consent from the person to participate in the research voluntarily
3.Age between 20 and 65 at the time of obtaining consent (regardless of gender)

Key exclusion criteria

1.Subjects with serious liver disorder, cardiovascular disorder, respiratory disorder, endocrine disorder, metabolic disorder
2.Subjects who may have an allergic reaction to tea or test food
3.Subjects who are pregnant, breastfeeding, or intend to become pregnant during the study period
4.Irregular menstrual cycle
5. Persons with extremely irregular eating habits, shift workers, late-night workers
6.Subjects who have collected more than 200 mL of blood within 1 month or more than 400 mL within 3 months before the start of this study (blood donation, etc.)
7.Subjects who regularly use pharmaceuticals (including herbal medicines) and supplements
8.Those who cannot agree with the purpose of the explanation of the test conducted in advance.
9.In addition, those who are judged to be inappropriate for this study by the study supervisor

Target sample size

10

Name of lead principal investigator

1st name	Osam
Middle name
Last name	Mazda

Organization

kyoto prefectural university of medicine

Division name

Department of Immunology

Zip code

602-8566

Address

Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji 465, JAPAN

TEL

0752515329

Email

mazda@koto.kpu-m.ac.jp

Name of contact person

1st name	Eri
Middle name
Last name	Watanabe

Organization

kyoto prefectural university of medicine

Division name

Department of Immunology

Zip code

6028566

Address

Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji 465, JAPAN

TEL

0752515329

Homepage URL

Email

e-w@koto.kpu-m.ac.jp

Institute

kyoto prefectural university of medicine

Institute

Department

Personal name

Organization

ITO EN, LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto Prefectural University of Medicine Medical Ethics Review Committee

Address

Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji 465, JAPAN

Tel

075-251-5337

Email

rinri@koto.kpu-m.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

07

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

07

Month

25

Day

Date of IRB

Anticipated trial start date

2023

Year

09

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

07

Month

25

Day

Last modified on

2023

Year

07

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059016