UMIN-CTR Clinical Trial

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

dyslipidemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Internal Medicine(1),Osaka
Medical College

Institute

Department

Personal name

Organization

National Agriculture and Food Research
Organization

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 related 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