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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005224
Receipt No. R000006207
Scientific Title A multicenter randomized, double-blind, placebo-controlled trial to evaluate the body fat reducing efficacy and safety of a beverage containing tea catechins on obese subjects.
Date of disclosure of the study information 2011/03/14
Last modified on 2019/07/25

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Basic information
Public title A multicenter randomized, double-blind, placebo-controlled trial to evaluate the body fat reducing efficacy and safety of a beverage containing tea catechins on obese subjects.
Acronym Body fat reducing effects of tea catechins on obese subjects.
Scientific Title A multicenter randomized, double-blind, placebo-controlled trial to evaluate the body fat reducing efficacy and safety of a beverage containing tea catechins on obese subjects.
Scientific Title:Acronym Body fat reducing effects of tea catechins on obese subjects.
Region
Japan

Condition
Condition obesity
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the body fat reducing efficacy and safety of a beverage containing tea catechins in obese subjects.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Visceral fat accumulation
Key secondary outcomes abdominal subcutaneous fat area, abdominal total fat area, body weight, body mass index, waist circumference, hip circumference, body fat ratio, body fat mass, and fat-free mass.

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 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 540mg of catechins) 1bottle per day for 12weeks.
Interventions/Control_2 Placebo beverage 1bottle per day for 12weeks.
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 20-65 aged men and postmenopausal women.
Health men and women with BMI 25-35kg/m^2.
Written informed consent obtained.
Key exclusion criteria Diabetes mellitus
History of cardiovascular disease
Abnormal liver function
Abnormal renal function
Pregnancy
Constant use of oral medication or supplements affecting body fat and/or body weight.
Inadequate with physician's decision
Target sample size 200

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)、厚生医院(東京都)、平塚胃腸病院(東京都)、中山産婦人科クリニック(埼玉県)、久野マインズタワークリニック(東京都)、亀戸南口クリニック(東京都)、段塚クリニック(埼玉県)、プライムクリニック(埼玉県)

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
After 12 weeks of daily ingestion, abdominal total fat area (p<0.01), abdominal visceral fat area (p<0.01) and abdominal subcutaneous fat area (p<0.01) in the catechin group (both women and men) were lower than corresponding values in the placebo group when average changes from the baseline were compared. Body weight (p<0.01), body fat ratio (p<0.01), body fat mass (p<0.01), waist (p<0.01), hip (p<0.05) and blood pressure (p<0.01) were also significantly lower in the catechin group in similar comparisons. Adverse effects caused by the catechin-containing beverage were not observed.
Effect of intake of a beverage containing 540mg catechins on the body composition of obese women and men.  Prog.Med. 25:1945-1957,2005
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
2005 Year 01 Month 05 Day
Date of IRB
2005 Year 01 Month 05 Day
Anticipated trial start date
2005 Year 01 Month 01 Day
Last follow-up date
2005 Year 05 Month 01 Day
Date of closure to data entry
2005 Year 06 Month 01 Day
Date trial data considered complete
2005 Year 06 Month 01 Day
Date analysis concluded
2005 Year 08 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=R000006207

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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