Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils

Not Applicable

• Conditions: Hypertriglyceridaemia; Familial Hypercholesterolaemia
• Interventions: Dietary Supplement: Fish oil capsule; Drug: HMG Coenzyme reductase

• Registration Number: NCT01577056
• Lead Sponsor: The University of Western Australia

Brief Summary

The purpose of this study is to determine whether fish oil supplementation is effective in the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.

Detailed Description

The use of statin therapy in familial hypercholesterolaemia (FH) is known to reduce cardiovascular risk and is a first line recommendation, however, there is considerable residual risk predicted by the presence of fasting and post-prandial hypertriglyceridaemia.

This study will examine the effect of oral n-3 fatty acid ethyl esters supplementation (4g/day, Omacor) on postprandial hypertriglyceridaemia and post-prandial arterial function when administrated to FH patients at increased risk of cardiovascular disease due to their residual fasting hypertriglyceridaemia.

Study Timeline

• Status Verified: 2012-04
• Study Start: 2012-04
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-11
• Last Update Submitted: 2012-04-11
• Study First Posted: 2012-04-13
• Last Update Posted: 2012-04-13
• Primary Completion: 2013-12
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with FH (genetically defined LDL-receptor mutation or Dutch score >8) on statin treatment only
• Hypertriglyceridaemia on a random blood sample (triglycerides >1.5mml/L)

Exclusion Criteria

• Subjects with diabetes mellitus
• major systemic illness or use of steroids or other lipid-regulating drugs (such as niacin, fibrate and colesevelam)
• patients on hypocaloric diets or LDL apheresis; anaemia, haemorrhage and pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fish oil	Fish oil capsule	-
Placebo	HMG Coenzyme reductase	FH subjects with standard treatment (statin treatment)

Primary Outcome Measures

Name	Time	Method
Postprandial changes in triglyceride-rich lipoprotein concentrations	12 weeks	Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate

Secondary Outcome Measures

Name	Time	Method
Triglyceride-rich lipoprotein kinetics	12 weeks	Kinetic studies of apoB48 and apoB-100 kinetics

Trial Locations

Locations (1)

School of Medicine & Pharmacology,University of Western Australia; 🇦🇺 Perth, Western Australia, Australia