Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils (FIFH)

The University of Western Australia

Status: Unknown

Conditions: Familial Hypercholesterolaemia; Hypertriglyceridaemia

Treatments: Dietary Supplement: Fish oil capsule; Drug: HMG Coenzyme reductase

Study type: Interventional

Funder types: Other

Identifiers

NCT01577056

NHMRC1028883 (Other Grant/Funding Number)

1028883

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Fish oil

Active Comparator group

Treatment:

Dietary Supplement: Fish oil capsule

Placebo

Placebo Comparator group

Description:

FH subjects with standard treatment (statin treatment)

Treatment:

Drug: HMG Coenzyme reductase