Effect of Rapeseed Oil and Sunflower Oil

June 17, 2009 updated by: Medical University of Vienna

Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna
        • Contact:
        • Contact:
          • Marika Miklautsch
        • Principal Investigator:
          • Marika Miklautsch, Mag.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lifestyle counseling
Dietary supplement: rapeseed oil
rapeseed oil in amounts between 14 and 27 g
ACTIVE_COMPARATOR: sunflower oil
Dietary supplement: sunflower oil
sunflower oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood analysis including fasting serum lipoproteins (TC, LDLc; HDLc; TG, Lp(a), Apolipoprotein A-1, Apolipoprotein B, BB, hs-CRP, GOT, GPT, GGT, acid composition of plasma lipids.
Time Frame: done in Week 1, Week 7, Week 13
done in Week 1, Week 7, Week 13

Secondary Outcome Measures

Outcome Measure
Time Frame
Motivation, compliance, increase of quality of life.
Time Frame: done in Week 1 and Week 13
done in Week 1 and Week 13
Acceptance and approach to the disease.
Time Frame: done in Week 1 and Week 13
done in Week 1 and Week 13
Improvement of knowledge and understanding about the disease by the patients.
Time Frame: done in Week 1 and Week 13
done in Week 1 and Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ANTICIPATED)

July 1, 2010

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (ESTIMATE)

June 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 18, 2009

Last Update Submitted That Met QC Criteria

June 17, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EROSO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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