UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006503 |
|---|---|
| Receipt number | R000007712 |
| Scientific Title | A randomized, double-blind, placebo-controlled trial of the effects of green tea on lifestyle-related disease prevention and development of new green tea food enabling effective absorption 2010 |
| Date of disclosure of the study information | 2011/10/07 |
| Last modified on | 2011/10/07 16:53:16 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled trial of the effects of green tea on lifestyle-related disease prevention and development of new green tea food enabling effective absorption 2010
Acronym
Effects of green tea on lifestyle-related disease prevention 2011
Scientific Title
A randomized, double-blind, placebo-controlled trial of the effects of green tea on lifestyle-related disease prevention and development of new green tea food enabling effective absorption 2010
Scientific Title:Acronym
Effects of green tea on lifestyle-related disease prevention 2011
Region
| Japan |
Condition
Condition
metabolic syndrome
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of adding lecithin to Benihuuki green tea extracts on biomarkers of lifestyle-related diseases in subjects prone to metabolic syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) LDL-cholesterol
2) Total cholesterol
Key secondary outcomes
1) body weight, waist, blood pressure
2) Serum total cholesterol, sd-LDL, triglycerides
3) FBS, HbA1c, insulin
4) high sensitive C reactive protein, catechin receptor
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 200ml of Benihuuki green tea extracts beverage cartons twice a day (total of 400ml, the amount of catechins and lecithin are 400mg and 200mg, respectively) for 12 weeks.
Interventions/Control_2
Take 200ml of Benihuuki green tea extracts beverage cartons twice a day (total of 400ml, the amount of catechins and lecithin are 400mg and 0mg, respectively) for 12 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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From 30 years old to 70 years old and meets at least one of the followings;
1.LDL-Cholesterol: 130mg/dl or more
2.Daiy green tea intake: 3 cups or less
Key exclusion criteria
1) Individuals with a medical record of heart failure or cardiac infarction.
2) Individuals judged to have atrial fibrillation, Irregular Heart Beat, hepatic damage, kidney damage, cerebrovascular accident, rheumatism, diabetes mellitus, lipid disorder and/or anemia.
3) Individuals with a medical record of allergy to food and drug.
4) Pregnant women, or women with intending to become pregnant, and lactating women.
5) Individuals judged by the doctor to be unsuitable.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Sameshima |
Organization
Kakegawa municipal general hospital
Division name
Department of deigesitive disease
Zip code
Address
1-1-1, Sugiyaminami, Kakegawa, Shizuoka, Japan
TEL
81-537-22-6211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Yamada |
Organization
Kakegawa city
Division name
health and prevention division
Zip code
Address
9-28, Goshohara, Kakegawa, Shizuoka, Japan
TEL
81-537-23-8111
Homepage URL
http://www.kakegawastudy.jp/
Sponsor or person
Institute
Kakegawa City
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokoku University
Kyushu University
Name of secondary funder(s)
National Institute of Vegetable and Tea Science
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
掛川市徳育保健センター、掛川市大東保健センター
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 07 | Day |
Last modified on
| 2011 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007712
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
