Abstract
BackgroundLong-chain omega-3 polyunsaturated fatty acids (LCn-3PUFAs) may act as an effective adjunct therapy for chronic obstructive pulmonary disease (COPD), a condition characterised by persistent airflow limitation and inflammation. However, the nature of this illness presents challenges for evaluating potential benefits. The aim of this study was to determine the feasibility of undertaking a randomised controlled trial of LCn-3PUFA supplementation in adults with COPD.MethodsA 16-week parallel, double-blind, randomised, placebo-controlled dietary supplementation trial was conducted. Participants diagnosed with COPD were randomly allocated to take six 1-g capsules of fish oil (3.6 g LCn-3PUFA) or corn oil (placebo) daily for 16 weeks. Key outcomes used to determine the feasibility of the trial included recruitment rate, participant retention rate and supplement adherence (blood biomarker and returned capsule count). An estimate of the effect size for clinical outcomes such as pulmonary function and functional exercise capacity was calculated.ResultsNone of the key feasibility criteria were met. The enrolment target was 40 participants in 52 weeks; however, only 13 were finally enrolled, with just seven in the first 52 weeks. Eight participants completed the study (retention rate 62%). Targets for compliance were not achieved; red blood cell LCn-3PUFA content (expressed as percentage of total fatty acids) did not increase by more than 2% in the fish oil group; capsule counts were unreliable. As the target sample size was not achieved and only a small number of participants completed the study, it was not possible to use the variance in clinical outcomes to estimate a sample size for a future study.ConclusionsThis study highlights major difficulties, especially with recruitment, in conducting this LCn-3PUFA supplementation trial in people with COPD, rendering the protocol unfeasible by predetermined criteria. A modified approach is needed to investigate potential health benefits of fish oil in people with COPD. A multicentre study with changes to inclusion and exclusion criteria is recommended.Trial registrationAustralia and New Zealand Clinical Trials Register (ANZCTR), ACTRN12612000158864
Highlights
Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFAs) may act as an effective adjunct therapy for chronic obstructive pulmonary disease (COPD), a condition characterised by persistent airflow limitation and inflammation
There are two LCn3PUFAs that are of particular importance in inflammation: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), both of which are found in fish oil
The concept that anti-inflammatory and pro-resolutory actions of LCn-3PUFAs may act as an effective adjunct therapy in people with COPD was the driver for the proposed research
Summary
Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFAs) may act as an effective adjunct therapy for chronic obstructive pulmonary disease (COPD), a condition characterised by persistent airflow limitation and inflammation. Long-chain omega-3 fatty acids (LCn-3PUFAs) (found predominantly in fish) have been shown to have anti-inflammatory and proresolutory actions in the body [2]. The concept that anti-inflammatory and pro-resolutory actions of LCn-3PUFAs may act as an effective adjunct therapy in people with COPD was the driver for the proposed research. At the commencement of the study, there were no similar published trials in this population and there are recognised issues that may threaten the success of an efficacy study, such as slow recruitment, intervention non-compliance and high attrition (potentially due to polypharmacy, multi-morbidity, disease morbidity, and COPD exacerbations)
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