UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004226
Receipt number R000005080
Scientific Title A randomized, double-blind, placebo-controlled trial of the effects of green tea on lifestyle-related disease prevention and development of new green tea food enabling effective absorption 2010
Date of disclosure of the study information 2010/09/17
Last modified on 2011/10/07 16:59:31

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Basic information

Public title

A randomized, double-blind, placebo-controlled trial of the effects of green tea on lifestyle-related disease prevention and development of new green tea food enabling effective absorption 2010

Acronym

Effects of green tea on lifestyle-related disease prevention 2010

Scientific Title

A randomized, double-blind, placebo-controlled trial of the effects of green tea on lifestyle-related disease prevention and development of new green tea food enabling effective absorption 2010

Scientific Title:Acronym

Effects of green tea on lifestyle-related disease prevention 2010

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 effects of green tea extracts on biomarkers of lifestyle-related diseases in subjects prone to metabolic syndrome

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) LDL-cholesterol
2) Total cholesterol

Key secondary outcomes

1) body weight, waist, blood pressure
2) Serum total cholesterol, sd-LDL, triglycerides
3) FBS, HbA1c, insulin
4) high sensitive C reactive protein, catechin receptor


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

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Take 250ml of Benihuuki green tea extracts beverage cartons three times a day (total of 750ml, the amount of catechins and caffeine are 600mg and 105 mg, respectively) for 12 weeks.

Interventions/Control_2

Take 250ml of Benihuuki green tea extracts beverage cartons three times a day (total of 750ml, the amount of catechins and caffeine are 400mg and 95 mg, respectively) for 12 weeks.

Interventions/Control_3

Take 250ml of placebo beverage cartons three times a day (total of 750ml, the amount of catechins and caffeine are 0mg and 0mg, respectively) for 12 weeks.

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

From 30 years old to 70 years old and meets at least one of the followings;
1.BMI: 23 Kg/m2 or over
2.Total-cholesterol: 200 mg/dl or more
3.LDL-Cholesterol: 120mg/dl or more

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

160


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoichi Sameshima

Organization

Kakegawa municipal general hospital

Division name

Green tea medical application center

Zip code


Address

1-1-1, Sugiyaminami, Kakegawa, Shizuoka, Japan

TEL

81-0537-22-6211

Email



Public contact

Name of contact person

1st name
Middle name
Last name Mitsuhiro Yamada

Organization

Kakegawa city

Division name

Kakegawa city

Zip code


Address

9-28, Goshohara, Kakegawa, Shizuoka, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Kakegawa municipal general hospital

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Agriculture, Forestry and Fisheries

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Tokoku University

Name of secondary funder(s)

National Institute of Vegetable and Tea Science


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

掛川市徳育保健センター、掛川市大東保健センター


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 17 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

Completed

Date of protocol fixation

2010 Year 07 Month 27 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry

2011 Year 03 Month 01 Day

Date trial data considered complete

2011 Year 05 Month 01 Day

Date analysis concluded

2011 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 09 Month 17 Day

Last modified on

2011 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005080


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name