Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertriglyceridaemia Familial Hypercholesterolaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fish oil

Group Type ACTIVE_COMPARATOR

Fish oil capsule

Intervention Type DIETARY_SUPPLEMENT

4g Omega capsule for 12 weeks

Placebo

FH subjects with standard treatment (statin treatment)

Group Type PLACEBO_COMPARATOR

HMG Coenzyme reductase

Intervention Type DRUG

All FH subjects are on standard statin treatment during study period

Interventions

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Fish oil capsule

4g Omega capsule for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

HMG Coenzyme reductase

All FH subjects are on standard statin treatment during study period

Intervention Type DRUG

Other Intervention Names

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Omacor Statin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No