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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006503
Receipt No. 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

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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
Email

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/
Email

Sponsor
Institute Kakegawa City
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007712

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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