Effect of omega-3 fatty acids on inflammation and blood vessel function in abdominal aortic aneurysm

Investigation of the efficacy of inflammatory biomarkers and vascular function in patients with abdominal aortic aneurysm treated with omega-3 polyunsaturated fatty acids

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000483459

Enrollment

Registered

2016-04-13

Start date

2016-12-15

Completion date

2017-06-30

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

The primary purpose of this study is to determine whether omega-3 fatty acid dietary supplementation will reduce blood biomarkers of inflammation and improve blood vessel function in patients with a small abdominal aortic aneurysm. We hypothesize that 12 week dietary supplementation with omega-3 fatty acids will reduce the concentration of inflammatory biomarkers in the blood, and improve indices of arterial stiffness. We will recruit 50 patients who have small abdominal aortic aneurysm (maximal diameter of 3.0-4.9 cm, determined by non-invasive imaging techniques). Participants will visit the laboratory for testing on 4 separate occasions (Day 0 and Weeks 3, 8, and 12). Blood and urine collections, and testing of vascular function will carried out during the Day 0, Week 3 and Week 12 visits. Participants will be randomized to receive fatty acid capsules (active or placebo), and will take 3/day for 12 weeks. Participants and investigators will be blinded to the treatment groups. Unused capsules will be returned by the participant at their next visit. The research team include vascular surgeons and fundamental scientists.

Interventions

Daily oral administration of 1.8 g omega-3 fatty acid capsules (composition: eicosapentaenoic acid, 0.3 g; docosahexaenoic acid, 1.5 g), or equivolume of placebo for a duration of 12 weeks. Adherence will be measured by returned capsule count and analysis of cell membrane phospholipid fatty acid incorporation using GC-MS.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

55 Years to 86 Years

Healthy volunteers

Inclusion criteria

Participants will be included if they are between 55-86 years of age, male or female, smoker or non-smoker. All participants will have small AAA (3.0-4.9 cm maximal diameter, measured using ultrasound or CT). Participants must have the capacity to understand instructions, for example the procedures to be followed for capsule supplementation.

Exclusion criteria

We will exclude participants if they i) report a usual dietary intake of more than 2 oily fish meals per week, ii) report the use of fish oil or krill oil supplements iii) report the use of anti-inflammatory medications, iv) report an imminent surgical procedure, v) have cognitive impairment that presents a risk that instructions will not be followed accurately vi) the prospective participant's treating physician deems them unsuitable for the trial.

Outcome results