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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036218
Receipt No. R000041257
Scientific Title Effect of test food on triglyceride and LDL-cholesterol level -open trial-
Date of disclosure of the study information 2019/03/16
Last modified on 2019/04/24

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Basic information
Public title Effect of test food on triglyceride and LDL-cholesterol level -open trial-
Acronym Effect of test food on triglyceride and LDL-cholesterol level -open trial-
Scientific Title Effect of test food on triglyceride and LDL-cholesterol level -open trial-
Scientific Title:Acronym Effect of test food on triglyceride and LDL-cholesterol level -open trial-
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effects of the intake of test food on triglyceride and LDL-cholesterol level
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LDL-cholesterol level
Key secondary outcomes Triglyceride, total cholesterol, waist circumference

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test food (low dose) for 12 consecutive weeks
Interventions/Control_2
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
64 years-old >
Gender Male and Female
Key inclusion criteria (1) Males and females from 20 to 64 years of age
(2) Serum LDL- cholesterol level are ranged from 120 mg/dL to 139 mg/dL
Key exclusion criteria (1) Subjects who routinely take foods or medicines affecting the test result
(2) Subjects who drink green tea more than once a day
(3) Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required
(4) Subjects who have under treatment or a history of serious disease (e.g., diabetes, or liver disease, kidney disease, or heart disease)
(5) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(6) Subjects having possibilities for emerging allergy related to the study
(7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(8) Subjects participating in other clinical study
(9) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period
(10) Subjects who are judged unfit to enroll in this trial by the investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masaharu
Middle name
Last name Ohkawara
Organization Satoen Co., LTD.
Division name none
Zip code 421-1392
Address 1057 Ohhara, Aoi-ku, Shizuoka, Japan
TEL 054-270-1336
Email masaharu-ohkawara@satoen.co.jp

Public contact
Name of contact person
1st name Hiroyasu
Middle name
Last name Shimada
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code 150-0021
Address 1-20-2 Ebisu-nishi, Shibuya-ku, Tokyo, Japan
TEL 03-5459-5329
Homepage URL
Email h.shimada@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization Satoen Co., 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 Aisei Hospital Ueno Clinic Reserch Ethics Committee
Address 2-18-6, Higasiueno, Taito-ku, Tokyo, Japan
Tel 03-6455-0880
Email t.saito@ttc-smo.jp

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
2019 Year 03 Month 16 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
2019 Year 02 Month 28 Day
Date of IRB
2019 Year 02 Month 28 Day
Anticipated trial start date
2019 Year 03 Month 17 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 15 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041257

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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