ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Rapeseed Oil and Sunflower Oil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00924274
Recruitment Status : Unknown
Verified June 2009 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : June 18, 2009
Last Update Posted : June 18, 2009
Sponsor:
Information provided by:
Medical University of Vienna

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Familial Hypercholesterolemia Dietary Supplement: rapeseed oil Dietary Supplement: sunflower oil Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia
Study Start Date : March 2008
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924274


Locations
Austria
Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Marika Miklautsch, Mag.    0043 40 400 ext 2051    marika.miklautsch@meduniwien.ac.at   
Contact: Marika Miklautsch         
Principal Investigator: Marika Miklautsch, Mag.         
Sponsors and Collaborators
Medical University of Vienna

Responsible Party: Kurt Widhalm/Prof., Devision Nutrition and Metabolsim, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00924274     History of Changes
Other Study ID Numbers: EROSO
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: June 18, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias