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Recruitment status
Unique ID issued by UMIN UMIN000001722
Receipt No. R000002071
Scientific Title A randomized, double-blind, placebo-controlled study of effect of green tea on lifestyle-related disease prevention
Date of disclosure of the study information 2009/02/21
Last modified on 2009/02/20

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Basic information
Public title A randomized, double-blind, placebo-controlled study of effect of green tea on lifestyle-related disease prevention
Acronym Effect of green tea on lifestyle-related disease prevention
Scientific Title A randomized, double-blind, placebo-controlled study of effect of green tea on lifestyle-related disease prevention
Scientific Title:Acronym Effect of green tea on lifestyle-related disease prevention
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 effect of green tea powder on preventive biomarkers of lifestyle-related disease in subjects prone to metabolic syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) body weight
2) HbA1c
3) LDL-cholesterol
Key secondary outcomes 1) Blood pressure, fat percentage, waist, BMI
2) FBS, insulin
3) Serum total cholesterol, HDL-cholesterol, triglycerides
4) Serum amyloid protein A, high sensitive C_reactive protein
5) Adiponectin, TNF-alfa, urine 8-OHdG

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 Ten capsules of green tea powder, three times a day (6g/day), for 12 weeks.
Interventions/Control_2 Ten placebo capsules, three times a day (6g/day), 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
75 years-old >=
Gender Male and Female
Key inclusion criteria Is over 30 years old and under 75 years old and meets at least one of the followings;
1.BMI:23-35Kg/m2
2.Waist circumference: 85cm or more in males and 90cm or more in females
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 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Sameshima
Organization Kakegawa city general hospital
Division name Green tea medical application center
Zip code
Address 1-1-1, Sugiyaminami, Kakegawa, Shizuoka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhiro Yamada
Organization Kakegawa city
Division name Health Protection Section
Zip code
Address 9-28, Goshohara, Kakegawa, Shizuoka, Japan
TEL
Homepage URL
Email

Sponsor
Institute Kakegawa Research Council for application of green tea in preventive medicine
Institute
Department

Funding Source
Organization Kakegawa City
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2009 Year 02 Month 21 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
Date of protocol fixation
2008 Year 12 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2009 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 20 Day
Last modified on
2009 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002071

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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