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Effect of Rapeseed Oil and Sunflower Oil

Primary Purpose

Familial Hypercholesterolemia

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
rapeseed oil
sunflower oil
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Familial Hypercholesterolemia

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle counseling

sunflower oil

Arm Description

Outcomes

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.

Secondary Outcome Measures

Motivation, compliance, increase of quality of life.
Acceptance and approach to the disease.
Improvement of knowledge and understanding about the disease by the patients.

Full Information

First Posted
June 17, 2009
Last Updated
June 17, 2009
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00924274
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Title
sunflower oil
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
rapeseed oil
Intervention Description
rapeseed oil in amounts between 14 and 27 g
Intervention Type
Dietary Supplement
Intervention Name(s)
sunflower oil
Intervention Description
sunflower oil
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Motivation, compliance, increase of quality of life.
Time Frame
done in Week 1 and Week 13
Title
Acceptance and approach to the disease.
Time Frame
done in Week 1 and Week 13
Title
Improvement of knowledge and understanding about the disease by the patients.
Time Frame
done in Week 1 and Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marika Miklautsch, Mag.
Phone
0043 40 400
Ext
2051
Email
marika.miklautsch@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Marika Miklautsch
First Name & Middle Initial & Last Name & Degree
Marika Miklautsch, Mag.

12. IPD Sharing Statement

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Effect of Rapeseed Oil and Sunflower Oil

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