UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005223 |
|---|---|
| Receipt number | R000006206 |
| Scientific Title | Effects of green tea extract high in catechins on obese subjects |
| Date of disclosure of the study information | 2011/03/14 |
| Last modified on | 2019/07/25 06:23:40 |
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Basic information
Public title
Effects of green tea extract high in catechins on obese subjects
Acronym
Effects of tea catechins on obesity.
Scientific Title
Effects of green tea extract high in catechins on obese subjects
Scientific Title:Acronym
Effects of tea catechins on obesity.
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The body fat reducing effect and reduction of risk for cardiovascular disease by continuous ingestion of a green tea extract high in catechins were investigated in humans with typical lifestyles.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight, body mass index, body fat ratio, body fat mass, waist circumference, hip circumference, abdominal visceral fat area, and abdominal subcutaneous fat area
Key secondary outcomes
Blood pressure and serum low-density lipoprotein cholesterol.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Catechin beverage (containing 582.8mg of catechins) 1 can per day for 12 weeks.
Interventions/Control_2
Control beverage (containing 96.3mg of catechins) 1 can per 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
| 25 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese women and men 25 to 55 years age with body mass index of 24 to 30 kg/m^2 and/or waist circumference of 80 to 94cm.
Key exclusion criteria
Serious liver disease
Serious renal disease
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Tsuchida |
Organization
Isogo Central Hospital
Division name
Center of health examination.
Zip code
Address
2-20-45, Isogo Isogo-ku Yokohama Japan
TEL
045-752-1217
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Kozuma |
Organization
Kao Corporation
Division name
Health Care Food Research Labs.
Zip code
Address
2-1-3, Bunka Sumida-ku Tokyo Japan
TEL
03-5630-7268
Homepage URL
kouzuma.kazuya@kao.co.jp
Sponsor or person
Institute
Esucal Laboratories
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
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
磯子中央病院（神奈川県）、児玉中央病院（埼玉県）、セントラル病院（東京都）、厚生病院（東京都）、中山産婦人クリニック（埼玉県）、久野マインズタワークリニック（東京都）、亀戸駅前クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
RESULTS: Data were analyzed using per-protocol samples of 240 subjects (catechin group; n = 123, control group; n = 117). Decreases in body weight, body mass index, body fat ratio, body fat mass, waist circumference, hip circumference, visceral fat area, and subcutaneous fat area were found to be greater in the catechin group than in the control group. A greater decrease in systolic blood pressure (SBP) was found in the catechin group compared with the control group for subjects whose initial SBP was 130 mm Hg or higher. Low-density lipoprotein (LDL) cholesterol was also decreased to a greater extent in the catechin group. No adverse effect was found.
DISCUSSION: The continuous ingestion of a green tea extract high in catechins led to a reduction in body fat, SBP, and LDL cholesterol, suggesting that the ingestion of such an extract contributes to a decrease in obesity and cardiovascular disease risks.
Obesity. 2007;15(6):1473-1483.
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
Main results already published
Date of protocol fixation
| 2002 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2002 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2002 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2002 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2002 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2002 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2002 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 09 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006206
