UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044409 |
|---|---|
| Receipt number | R000050636 |
| Scientific Title | A Study on the Easy Absorbability of the Tea Catechin with Lipid |
| Date of disclosure of the study information | 2021/06/04 |
| Last modified on | 2021/12/02 15:24:44 |
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Basic information
Public title
A Study on the Easy Absorbability of the Tea Catechin with Lipid
Acronym
A Study on the Easy Absorbability of the Tea Catechin with Lipid
Scientific Title
A Study on the Easy Absorbability of the Tea Catechin with Lipid
Scientific Title:Acronym
A Study on the Easy Absorbability of the Tea Catechin with Lipid
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare and confirm the absorption of the test food over time.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood catechin concentration
(before ingestion, and 1,3,6,8,10,24 hours after ingestion. [observation period I and II]).
Key secondary outcomes
*Secondary outcomes
[1] Catechin density in urine.
*Other index
[1]Blood pressure, pulsation.
[2]Weight, body fat percentage, BMI.
[3]Hematologic test.
[4]Blood biochemical test.
[5]Urine analysis.
[6]Subject's diary.
[7]Doctor's questions.
[8]Questionnaire of physical feeling.
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
[1]Oral ingestion of a test product (1 time).
[2]Observation.
[3]Washout (over 6 days)
[4]Oral ingestion of the control product (1 time).
[5]Observation.
Interventions/Control_2
[1]Oral ingestion of the control product (1 time).
[2]Observation.
[3]Washout (over 6 days)
[4] Oral ingestion of a test food (1 time).
[5]Observation.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1] Healthy Japanese males who are aged 30-64 years and whose written informed consent has been obtained.
[2]Individuals who can stop taking supplements, foods, and healthy teas that may affect the test from 3 days prior to the start of the test until the end of the test.
[3]Individuals who can stop intaking medicine(s) 1 month prior to the test.
[4]Individuals who can stop consuming foods and beverages containing catechins or caffeine, such as tea (green tea, black tea, oolong tea, jasmine tea, etc.), coffee, wine, etc., from 3 days prior to the test day until the end of the test.
[5]Individuals who can maintain a consistent daily routine during the test period.
[6]Individuals who have ingested the test product beforehand and confirmed that they can ingest it without any problems (conducted in the screening test).
[7]Individuals who can communicate in Japanese or English without any problems.
Key exclusion criteria
[1]Individuals who are patient or have a history of diabetes, heart disease, kidney disease, cancer and other diseases.
[2]Individuals who use medical products.
[3]Individuals who have been taking healthy tea, supplements, and other products containing tea catechins continuously within 1 month of the start of the study.
[4]Individuals with serious anemia.
[5]Individuals who drink tea beverages over 1 L or more in a day.
[6]Individuals who cannot maintain their daily routine due to significant changes in diet and physical activity.
[7]Individuals who are sensitive to ingredients such as caffeine and catechins, causing eczema, nausea, and diarrhea.
[8]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 20g/day).
[9]Subjects who are pregnant, lactating, or intending to be pregnant.
[10]Individuals whose BMI is over 30 kg/m2.
[11]Individuals who participate with other clinical trial in the past 1 month.
[12]Individuals judged inappropriate for the study by the principal.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazumoto |
| Middle name | |
| Last name | Sasaki |
Organization
Medical Corporation Ichigenkai Sasaki Memorial Hospital
Division name
Chief Director
Zip code
359-1144
Address
1-7-25 Nishitokorozawa Tokorozawa-shi Saitama 359-1144, JAPAN
TEL
+81-429-23-7751
soumuka@sasaki-memorial.com
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness, Inc.
Division name
Representative Director
Zip code
103-0023
Address
Nihonbashi Hase Building No. 516, 3-1-6 Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023, JAPAN
TEL
+81-80-4163-4418
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
CXwellness, Inc.
Institute
Department
Personal name
Funding Source
Organization
FUJI OIL CO., LTD
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
i.takahashi@tes-h.co.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
| 2021 | Year | 06 | Month | 04 | 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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | 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 | 06 | Month | 03 | Day |
Last modified on
| 2021 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050636
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| Registered date | File name |
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