UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029130 |
|---|---|
| Receipt number | R000033310 |
| Scientific Title | Effects of green tea catechins on cholesterol synthesis/absorption markers in Japanese adults: a single-arm, open-label trial. |
| Date of disclosure of the study information | 2017/10/23 |
| Last modified on | 2018/03/15 09:35:21 |
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Basic information
Public title
Effects of green tea catechins on cholesterol synthesis/absorption markers in Japanese adults: a single-arm, open-label trial.
Acronym
Effects of green tea catechins on cholesterol synthesis/absorption markers in Japanese adults: a single-arm, open-label trial.
Scientific Title
Effects of green tea catechins on cholesterol synthesis/absorption markers in Japanese adults: a single-arm, open-label trial.
Scientific Title:Acronym
Effects of green tea catechins on cholesterol synthesis/absorption markers in Japanese adults: a single-arm, open-label trial.
Region
| Japan |
Condition
Condition
Borderline hyper LDL cholesterolemia
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate effects of the intake of green tea catechins on cholesterol synthesis/absorption markers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cholesterol synthesis and absorption markers(0, 4, and 8 wk)
Key secondary outcomes
1) Synthesis/absorption(0, 4, and 8 wk)
2) LDL-cholesterol(0, 4, and 8 wk)
3) HDL-cholesterol(0, 4, and 8 wk)
4) Total cholesterol(0, 4, and 8 wk)
5) LDL/HDL(0, 4, and 8 wk)
6) Correlation between changing rate of LDL-cholesterol and changing rate of each of cholesterol absorption and synthesis markers from baseline to 8 weeks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A green tea beverage was given twice a day at mealtimes for 8 weeks.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects judged to be appropriate by the responsible physician
2) Subjects have a higher LDL- cholesterol in screening test (the responsible physician may exclude subjects with extremely low cholesterol absorption markers )
Key exclusion criteria
1) A history of malignant tumor, heart failure, or myocardial infarct
2) Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia or hypertension
3) Subjects use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily
4) Currently taking medicines and/or herbal medicine
5) Those who are allergic to medicines and/or the test food related products
6) Pregnant, subjects with lactation period, or subjects having the mind to become pregnant in the test period
7) Subjects who participated in other clinical tests in 3 months before writing informed consent of this study was obtained
8) Subjects who are inadequate for enrollment judged by the responsible physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Sagesaka, PhD |
Organization
ITO EN, Ltd.
Division name
Central Research Institute
Zip code
Address
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL
0548-54-1247
y-sagesaka@itoen.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Kobayashi, PhD |
Organization
ITO EN, Ltd.
Division name
Central Research Institute
Zip code
Address
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL
0548-54-1247
Homepage URL
m-kobayasi@itoen.co.jp
Sponsor or person
Institute
Central Research Institute, ITO EN, Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Orthomedico Inc.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人社団盛心会 タカラクリニック
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 23 | 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
| 2017 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 13 | Day |
Last modified on
| 2018 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033310
