Clinical trial NCT01577056: Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils
Official title: Effect of Fish Oil Supplementation on Postprandial Lipid Metabolism in Familial Hypercholesterolaemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertriglyceridaemia
Familial Hypercholesterolaemia
Keywords: Familial hypercholesterolaemia
Postprandial dyslipidaemia
Fish oil treatment
Cardiovascular disease
Lead sponsor: The University of Western Australia
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2012-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postprandial changes in triglyceride-rich lipoprotein concentrations
timeFrame: 12 weeks
Secondary outcomes:
measure: Triglyceride-rich lipoprotein kinetics
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Perth
country: Australia
facility: School of Medicine & Pharmacology,University of Western Australia
state: Western Australia
Study officials:
affiliation: The University of Western Australia
name: Dick Chan, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan DC, Pang J, Barrett PH, Sullivan DR, Mori TA, Burnett JR, van Bockxmeer FM, Watts GF. Effect of omega-3 fatty acid supplementation on arterial elasticity in patients with familial hypercholesterolaemia on statin therapy. Nutr Metab Cardiovasc Dis. 2016 Dec;26(12):1140-1145. doi: 10.1016/j.numecd.2016.07.012. Epub 2016 Aug 3.
citation: Chan DC, Pang J, Barrett PH, Sullivan DR, Burnett JR, van Bockxmeer FM, Watts GF. omega-3 Fatty Acid Ethyl Esters Diminish Postprandial Lipemia in Familial Hypercholesterolemia. J Clin Endocrinol Metab. 2016 Oct;101(10):3732-3739. doi: 10.1210/jc.2016-2217. Epub 2016 Aug 4.