UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051709 |
|---|---|
| Receipt number | R000059016 |
| Scientific Title | Pilot study on pharmacokinetics of tea ingredients |
| Date of disclosure of the study information | 2023/07/25 |
| Last modified on | 2023/07/25 14:35:20 |
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Basic information
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
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
Primary outcomes
Blood concentration and saliva concentration of tea polyphenols
Key secondary outcomes
Base
Study type
Interventional
Study design
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
Intervention
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
Eligibility
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
Research contact person
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
mazda@koto.kpu-m.ac.jp
Public contact
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
e-w@koto.kpu-m.ac.jp
Sponsor or person
Institute
kyoto prefectural university of medicine
Institute
Department
Personal name
Funding Source
Organization
ITO EN, LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
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
rinri@koto.kpu-m.ac.jp
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
| 2023 | Year | 07 | Month | 25 | 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
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
Other related information
Management 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/ctr_e/ctr_view.cgi?recptno=R000059016
