Effect of Rapeseed Oil and Sunflower Oil

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00924274
First received: June 17, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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 Intervention
Familial Hypercholesterolemia
Dietary Supplement: rapeseed oil
Dietary Supplement: sunflower oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 24
Study Start Date: March 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 17, 2009
Last Updated: June 17, 2009
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on July 29, 2014