UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005224
Receipt number 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 06:24:58

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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 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


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

Value
https://center6.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