Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils

Familial Hypercholesterolaemia Clinical Trial

— FIFH  

Official title:

Effect of Fish Oil Supplementation on Postprandial Lipid Metabolism in Familial Hypercholesterolaemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01577056
• Other study ID #: 1028883
• Secondary ID: NHMRC1028883
• Status: Not yet recruiting
• Phase: N/A
• First received: April 10, 2012
• Last updated: April 11, 2012
• Start date: April 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2012
• Source: The University of Western Australia
• Contact: Dick Chan, PhD
• Phone: 61-8-92240268
• Email: dick.chan[@]uwa.edu.au
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Familial Hypercholesterolaemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II
• Hypertriglyceridaemia
• Hypertriglyceridemia

Intervention

Dietary Supplement:
• Fish oil capsule
4g Omega capsule for 12 weeks

Drug:
• HMG Coenzyme reductase
All FH subjects are on standard statin treatment during study period

Locations

Country	Name	City	State
Australia	School of Medicine & Pharmacology,University of Western Australia	Perth	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
The University of Western Australia	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial changes in triglyceride-rich lipoprotein concentrations	Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate	12 weeks	No
Secondary	Triglyceride-rich lipoprotein kinetics	Kinetic studies of apoB48 and apoB-100 kinetics	12 weeks	No