UMIN-CTR Clinical Trial

Public title

A study for evaluating the LDL cholesterol reduction effect by ingestion of tea catechins containing beverage

Acronym

A study for evaluating the LDL cholesterol reduction effect by ingestion of tea catechins containing beverage

Scientific Title

A study for evaluating the LDL cholesterol reduction effect by ingestion of tea catechins containing beverage

Scientific Title:Acronym

A study for evaluating the LDL cholesterol reduction effect by ingestion of tea catechins containing beverage

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the effects of ingestion of a beverage containing tea catechins on LDL cholesterol level for 12 weeks.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

LDL cholesterol

Key secondary outcomes

Total cholesterol

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of test beverage containing tea catechins for 12 consecutive weeks

Interventions/Control_2

Ingestion of placebo beverage for 12 consecutive weeks

Interventions/Control_3

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

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Males and females from 20 years of age
(2)LDL cholesterol level is border area (120-139 mg/dL) or mild area (140-159 mg/dL) at preliminary examination

Key exclusion criteria

(1)Subjects who ingestion of a large amount tea catechins containing food
(2)Subjects who have been ingesting any article (such as health food and medicine) that may affect serum lipid level or lipid metabolism
(3)Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor
(4)Subjects who has under treatment or a history of serious disease (e.g., diabetes, or liver disease, kidney disease, or heart disease)
(5)The female of the menopause front where a menstrual cycle is irregular (besides 28days plus minus 4days)
(6)Subjects having possibilities for emerging allergy related to the study
(7)Serum triglyceride more than 400 mg/dL on preliminary examination
(8)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(9)Subjects who are judged as unsuitable for the study based on the results of dietary habit questionnaire
(10)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(11)Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire
(12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(13)Subjects who are judged as unsuitable for the study by the investigator (subinvestigator) for other reason

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Yuuichi Ukawa

Organization

ITO EN,LTD

Division name

Central Research Institute

Zip code

Address

21,Mekami,Makinohara-city,Shizuoka

TEL

0548-54-1247

Email

y-ukawa@itoen.co.jp

Name of contact person

1st name
Middle name
Last name	Chiharu Goto

Organization

TTC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

c.goto@ttc-tokyo.co.jp

Institute

TTC Co.,Ltd.

Institute

Department

Personal name

Organization

ITO EN,LTD

Organization

Division

Category of Funding Organization

Profit 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

2016

Year

07

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

07

Month

13

Day

Date of IRB

2016

Year

07

Month

13

Day

Anticipated trial start date

2016

Year

07

Month

16

Day

Last follow-up date

2017

Year

02

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

07

Month

15

Day

Last modified on

2019

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026726