UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005223
Receipt No. 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 (Ver. 2)

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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
Email

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
Email kouzuma.kazuya@kao.co.jp

Sponsor
Institute Esucal Laboratories
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006206