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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023185
Receipt No. R000026726
Scientific Title A study for evaluating the LDL cholesterol reduction effect by ingestion of tea catechins containing beverage
Date of disclosure of the study information 2016/07/15
Last modified on 2016/10/18

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Basic information
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
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes LDL cholesterol
Key secondary outcomes Total cholesterol

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute TTC Co.,Ltd.
Institute
Department

Funding Source
Organization ITO EN,LTD
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 15 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 No longer recruiting
Date of protocol fixation
2016 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 16 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
2016 Year 07 Month 15 Day
Last modified on
2016 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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