Effect of Fish oil supplementation on inflammation of blood vessels in people with heart disease

Effect of high-dose fish oil supplementation on arterial inflammation in patients with elevated lipoprotein (a)

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000377831

Enrollment

Registered

2021-04-01

Start date

2019-12-13

Completion date

2022-07-11

Last updated

2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aims: To investigate the effect of high-dose fish oil supplementation on inflammation of blood vessels in participants with stable heart disease receiving standard cholesterol-lowering therapy. Hypothesis: In participants with elevated Lp(a) levels and stable heart disease, high-dose fish oil supplementation will significantly reduce inflammation of blood vessels.

Interventions

Fish oils are a rich source of long-chain omega-3 fatty acids, primarily eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Fish oil taken as oral capsules (1g/capsule), containing omega-3 marine triglycerides 600mg as: EPA 360mg and DHA 240mg, taken as 6 capsules per day (3.6g omega-3 per day) for 12 weeks. Patients adherence is measured by consumed capsule counts routinely.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

45 Years to 69 Years

Healthy volunteers

Inclusion criteria

Inclusion criteria: aged between 45-69 years of age with elevated fasting Lp(a) levels (>0.5g/L), stable coronary artery disease and on maximally tolerated doses of lipid-lowering therapy, including a statin, and achieving a fasting LDL-cholesterol of <4.0 mmol/L. Stable coronary artery disease will be defined as previous coronary event (myocardial infarction, stroke, re-vascularisation procedure) >3 months ago or established coronary artery calification (>400) following CT coronary angiogram.

Exclusion criteria

Exclusion criteria: unstable coronary artery disease or a cardiovascular event within the last 3 months, fasting blood sugar level >7.2 mmol/L, tachyarrhthmias, women who are pregnant or lactating, a previous diagnosis of a severe co-existing medical condition that would prevent participation (eg: severe dementia or terminal illness), <45 or >70 years of age, or unable to provide a written informed consent.

Outcome results