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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044409
Receipt No. 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 2021/06/03

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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
Email 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
Email uetake@cx-wellness.com

Sponsor
Institute CXwellness, Inc.
Institute
Department

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
Email 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 Preinitiation
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 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050636

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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