Effect of Rapeseed Oil and Sunflower Oil
Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2009
CompletedFirst Posted
Study publicly available on registry
June 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 18, 2009
June 1, 2009
2.3 years
June 17, 2009
June 17, 2009
Conditions
Outcome Measures
Primary Outcomes (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.
done in Week 1, Week 7, Week 13
Secondary Outcomes (3)
Motivation, compliance, increase of quality of life.
done in Week 1 and Week 13
Acceptance and approach to the disease.
done in Week 1 and Week 13
Improvement of knowledge and understanding about the disease by the patients.
done in Week 1 and Week 13
Study Arms (2)
Lifestyle counseling
EXPERIMENTALsunflower oil
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- chilren and adolescents between 6 and 18 years of age
- LDLc \> 130 mg/dl and
- TC \> 200 mg/dl
- day nutrition record
- written informed consent
You may not qualify if:
- overweight
- underweight
- mental disability
- drug therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna
Vienna, Vienna, 1090, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 17, 2009
First Posted
June 18, 2009
Study Start
March 1, 2008
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
June 18, 2009
Record last verified: 2009-06