Effect of Rapeseed Oil and Sunflower Oil

NCT ID: NCT00924274

Last Updated: 2009-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-12-31

Brief Summary

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Familial hypercholesterolemia (FH), an inherited disorder of lipoprotein metabolism, is a risk for early cardiovascular disease (CVD). This autosomal dominant disease is characterized by markedly elevated plasma concentrations of low density lipoprotein (LDL) and total cholesterol (TC). The purpose of this study is to compare the effect of a diet low in saturated fats but enriched either with rapeseed oil (RO) or sunflower oil (SO) in children and adolescents with FH on serum lipoproteins.

Detailed Description

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Conditions

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Familial Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Lifestyle counseling

Group Type EXPERIMENTAL

rapeseed oil

Intervention Type DIETARY_SUPPLEMENT

rapeseed oil in amounts between 14 and 27 g

sunflower oil

Group Type ACTIVE_COMPARATOR

sunflower oil

Intervention Type DIETARY_SUPPLEMENT

sunflower oil

Interventions

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rapeseed oil

rapeseed oil in amounts between 14 and 27 g

Intervention Type DIETARY_SUPPLEMENT

sunflower oil

sunflower oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* chilren and adolescents between 6 and 18 years of age
* LDLc \> 130 mg/dl and
* TC \> 200 mg/dl
* 7 day nutrition record
* written informed consent

Exclusion Criteria

* overweight
* underweight
* mental disability
* drug therapy
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Devision Nutrition and Metabolsim, Medical University of Vienna

Locations

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Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Facility Contacts

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Marika Miklautsch, Mag.

Role: primary

0043 40 400 ext. 2051

Marika Miklautsch

Role: backup

Other Identifiers

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EROSO

Identifier Type: -

Identifier Source: org_study_id

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