UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000312 |
|---|---|
| Receipt number | 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 14:38:36 |
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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
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
Sponsor or person
Institute
Graduate School of Human Ecology, Showa Women's University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000406
