UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001722 |
|---|---|
| Receipt number | 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 18:56:47 |
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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
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
Sponsor or person
Institute
Kakegawa Research Council for application of green tea in preventive medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002071
| 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 |
