UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015009
Receipt number R000017351
Scientific Title Study of the effect of tea on lipid metabolism, and creation of health foods (ice cream) processed from tea
Date of disclosure of the study information 2014/09/01
Last modified on 2018/07/19 22:09:50

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Basic information

Public title

Study of the effect of tea on lipid
metabolism, and creation of health foods (ice cream) processed from tea

Acronym

Study of the effect of tea on lipid
metabolism, and creation of health foods (ice cream) processed from tea

Scientific Title

Study of the effect of tea on lipid
metabolism, and creation of health foods (ice cream) processed from tea

Scientific Title:Acronym

Study of the effect of tea on lipid
metabolism, and creation of health foods (ice cream) processed from tea

Region

Japan


Condition

Condition

dyslipidemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effects of adding O-Methylated
EGCG to EGCG on biomarkers of lifestyle-related diseases in subjects prone to dyslipidemia

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, MDA-LDL,
triglycerides
3) FPG, HbA1c, glycated albumin, insulin
4) high sensitive C reactive protein, catechin sensing molecule
5) antioxidant action in vivo, metabolite
6) proinflammatory cytokine
7) AST, ALT, gamma-GTP
8) Serum iron, ferritin
9) adiponectin
10) urinalysis
11) diet survey
12) stool examinationstool examination (intestinal flora, enterobacterial genes involved in metabolism)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Take 3 g of Benifuuki green tea extracts
powder dissolved in 125 ml of ice cream once a day (the amount of catechins and O-methylated EGCG are 600 mg and 40 mg, respectively) for 12 weeks.

Interventions/Control_2

Take 1.5 g of Benifuuki green tea extracts
powder dissolved in 125 ml of ice cream once a day (the amount of catechins and O-methylated EGCG are 300 mg and 20 mg, respectively) for 12 weeks.

Interventions/Control_3

Take 0 g of Benifuuki green tea extracts
powder dissolved in 125 ml of ice cream once a day (the amount of catechins and O-methylated EGCG are 0 mg and 0 mg, 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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

From 20 years old to 80 years old and meets
the followings;
1.LDL-Cholesterol: 120mg/dl or higher
2.Body mass index: 18.5kg/m^2 or higher

Key exclusion criteria

0) HbA1c: less than 6.5%
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 severe 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

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiaki Hanafusa

Organization

Osaka Medical College

Division name

Department of Internal Medicine (1)

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka

TEL

072-683-1221

Email

hanafusa@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisashi Imbe

Organization

Osaka Medical College

Division name

Department of Internal Medicine (1)

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka

TEL

072-683-1221

Homepage URL


Email

in1297@poh.osaka-med.ac.jp


Sponsor or person

Institute

Department of Internal Medicine(1),Osaka
Medical College

Institute

Department

Personal name



Funding Source

Organization

National Agriculture and Food Research
Organization

Organization

Division

Category of Funding 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



Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.mdpi.com/2072-6643/10/7/924/htm

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

2014 Year 08 Month 25 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 01 Day

Last modified on

2018 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017351


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name