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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000312
Receipt No. R000000406
Scientific Title Randomized controlled trial for a new dietary education program to prevent Arteriosclerosis in Japanese hyperlipidemia patients
Date of disclosure of the study information 2006/02/01
Last modified on 2008/01/28

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Basic information
Public title Randomized controlled trial for a new dietary education program to prevent Arteriosclerosis in Japanese hyperlipidemia patients
Acronym RCT for a dietary education to prevent Arteriosclerosis
Scientific Title Randomized controlled trial for a new dietary education program to prevent Arteriosclerosis in Japanese hyperlipidemia patients
Scientific Title:Acronym RCT for a dietary education to prevent Arteriosclerosis
Region
Japan

Condition
Condition hyperlipidemia
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness of the dietary education program using FFQW65 to prevent Arteriosclerosis in Japanese hyperlipidemia patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes serum total cholesterol values one year after randomization
Key secondary outcomes other serum lipids (LDL, HDL,TG) etc. one year after randomization

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Individualized counseling using a booklet explaining the concepts of the new dietary education.
Interventions/Control_2 conventional education
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
35 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients with TC values of >=220 mg/dl or TG values of >=150 mg/dl or HDLC values of <40mg/dl or LDLC>=140 mg/dl, and gave written informed consent.
Key exclusion criteria Subjects taking hypoglygemic agents, cholesterol-lowering drugs, or anti-hypertensive drugs were excluded.
1)Oncet of Arteriosclarosis or DM
2)Taking cholesterol-lowering drugs
3)No clinincal laboratory data
4)Not receiving a response for FFQW65 dietary data
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mariko Watanabe
Organization Graduate School of Human Ecology, Showa Women's University
Division name Department of Human Nutrition
Zip code
Address 1-7 Taishido, Setagaya-ku, Tokyo
TEL 03-3411-5694
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mariko Watanabe
Organization Graduate School of Human Ecology, Showa Women's University
Division name Department of Human Nutrition
Zip code
Address 1-7 Taishido, Setagaya-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Graduate School of Human Ecology, Showa Women's University
Institute
Department

Funding Source
Organization Grants of the Ministry of Education, Science, Sports and Technology in Japan Grant-in-Aid for Scientific Research
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
2006 Year 02 Month 01 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 Completed
Date of protocol fixation
2004 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2004 Year 02 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 01 Month 01 Day
Date trial data considered complete
2008 Year 02 Month 01 Day
Date analysis concluded
2008 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 01 Month 25 Day
Last modified on
2008 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000406

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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