Effect of Rapeseed Oil and Sunflower Oil

• ClinicalTrials.gov Identifier: NCT00924274
• Recruitment Status: Unknown
• First Posted: June 18, 2009
• Last Update Posted: June 18, 2009
• Sponsor: Medical University of Vienna
• Information provided by: Medical University of Vienna

Tracking Information

• First Submitted Date: June 17, 2009
• First Posted Date: June 18, 2009
• Last Update Posted Date: June 18, 2009
• Study Start Date: March 2008
• Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 17, 2009): 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 ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 17, 2009)

• Motivation, compliance, increase of quality of life. [ Time Frame: done in Week 1 and Week 13 ]
• Acceptance and approach to the disease. [ Time Frame: 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Rapeseed Oil and Sunflower Oil
• Official Title: Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Familial Hypercholesterolemia

Intervention

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

Study Arms

• Experimental: Lifestyle counseling
  Intervention: Dietary Supplement: rapeseed oil
• Active Comparator: sunflower oil
  Intervention: Dietary Supplement: sunflower oil

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 17, 2009): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2010
• Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT00924274
• Other Study ID Numbers: EROSO
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kurt Widhalm/Prof., Devision Nutrition and Metabolsim, Medical University of Vienna
• Original Responsible Party: Same as current
• Current Study Sponsor: Medical University of Vienna
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Medical University of Vienna
• Verification Date: June 2009