UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040740 |
|---|---|
| Receipt number | R000046512 |
| Scientific Title | Comparative study on LDL-cholesterol level using powdered green tea |
| Date of disclosure of the study information | 2020/06/12 |
| Last modified on | 2020/11/25 08:37:05 |
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Basic information
Public title
Comparative study on LDL-cholesterol level using powdered green tea
Acronym
Comparative study on LDL-cholesterol level using powdered green tea
Scientific Title
Comparative study on LDL-cholesterol level using powdered green tea
Scientific Title:Acronym
Comparative study on LDL-cholesterol level using powdered green tea
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the intake of test food on LDL-cholesterol level
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum lipid
Key secondary outcomes
waist circumference, body fat percentage, blood glucose level, blood pressure, safety
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Intake of test food for 12 consecutive weeks
Interventions/Control_2
Intake of placebo food for 12 consecutive weeks
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females from 20 to 64 years of age
(2) Serum LDL- cholesterol level are ranged from 120 mg/dL to 139 mg/dL
(3) Preferentially select women with menopause or stable menstrual cycle
Key exclusion criteria
(1) Subjects who routinely take foods or medicines affecting the test result
(2) Subjects with fasting triglyceride value of 400 mg/dL or more
(3) Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required
(4) Subjects who have under treatment or a history of serious disease (e.g., diabetes, or liver disease, kidney disease, or heart disease)
(5) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(6) Subjects having possibilities for emerging allergy related to the study
(7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(8) Subjects participating in other clinical study
(9) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period
(10) Subjects who are judged unfit to enroll in this trial by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Ohkawara |
Organization
Satoen Co., LTD.
Division name
none
Zip code
421-1392
Address
1057 Ohhara, Aoi-ku, Shizuoka, Japan
TEL
054-270-1336
masaharu-ohkawara@satoen.co.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Tsuji |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
s.tsuji@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Satoen 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
t.saito@ttc-smo.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
| 2020 | Year | 06 | Month | 12 | 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
| 2020 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 10 | 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
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046512
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
