Effect of Rapeseed Oil and Sunflower Oil

Familial Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00924274
• Other study ID #: EROSO
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2009
• Last updated: June 17, 2009
• Start date: March 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Dietary Supplement:
• rapeseed oil
rapeseed oil in amounts between 14 and 27 g
• sunflower oil
sunflower oil

Locations

Country	Name	City	State
Austria	Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		done in Week 1, Week 7, Week 13	Yes
Secondary	Motivation, compliance, increase of quality of life.		done in Week 1 and Week 13	Yes
Secondary	Acceptance and approach to the disease.		done in Week 1 and Week 13	Yes
Secondary	Improvement of knowledge and understanding about the disease by the patients.		done in Week 1 and Week 13	Yes