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Can fish oil supplementation improve endothelial function in asymptomatic offspring of patients with peripheral arterial disease?

Can fish oil supplementation improve endothelial function in asymptomatic offspring of patients with peripheral arterial disease?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000996965
Enrollment
100
Registered
2011-09-19
Start date
2011-09-12
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Peripheral Arterial Disease (PAD) is a major public health problem in Australia. The incidence increases with age and an estimated 10-25% of men and women over the age of 55 years are affected. The ageing Australian population will see an increase in the prevalence of PAD and consequently the national annual health expenditure on cardiovascular disease is likely to increase, greatly exceeding the 5.4 billion dollars spent in 2000-01. PAD is preceded by endothelial dysfunction, show an increase in inflammatory markers and failing of the circulation in affected limbs. EPA and DHA have been demonstrated to exert anti-inflammatory effects within the blood vessel wall thus reducing the amount of potent inflammatory markers produced. They also exert anti-thrombotic effects thus increasing the flow of blood within vessels. Dietary supplementation with fish oil rich in n-3 PUFA has been shown to positively impact on vascular function in the setting of atherosclerosis. It is known that there is a heritable basis to PAD, however, little is known whether improvements in endothelial function can be achieved in asymptomatic children of those with established PAD using n-3 PUFA. Early detection and intervention using a non-invasive, readily available, affordable and acceptable supplement such as fish oil has the potential to improve clinical management and prevent or delay the onset of those at high risk of developing symptomatic PAD. The aim of this study is to implement a 12 week, moderate dose fish oil intervention (10ml/day containing ~1.5g EPA and ~1g DHA), that will result in clinically and statistically significant improvements in terms of: a) Endothelial function; b) Inflammation; c) Lipid status (Total cholesterol, LDL, HDL, TG); and d) Omega 3 Fatty Acid levels.

Interventions

Melrose Omega 18/12 liquid fish oil - AustL93186: ~1.5g EPA and ~1g DHA per 10ml oral daily dose for 12 weeks.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

To be included in the study, participants must have a parent with PAD, be aged 18 years and above, have impaired endothelial function and normal ABPI’s.

Exclusion criteria

Patients will be excluded if they (1) ingest 2g or more of total omega 3 daily as per Fish Food Frequency Questionnaire, (2) have a seafood allergy, (3) life expectancy less than 12 weeks, (4) are unable to communicate effectively to provide informed consent, (5) are receiving treatment doses of any antithrombotic agent or (6) receiving dual anti-platelet function drugs (such as aspirin plus clopidogrel or prasugrel or ticlopidine), or (7) are diagnosed with a bleeding disorder such as von Willebrand disease or haemophilia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026