A randomized trial comparing omega-3 fatty acid plasma levels after ingestion of emulsified and non-emulsified cod liver oil formulations

Abstract

Objectives: Emulsified formulations of omega-3 fatty acids may increase plasma concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) compared with non-emulsified formulations. The current study evaluated plasma concentrations of DHA + EPA as well as DHA and EPA individually following administration of emulsified vs non-emulsified cod liver oil formulations.

Methods: In this randomized, 2-period, crossover study (ClinicalTrials.gov NCT02428699), 47 healthy adults received single doses of an emulsified cod liver oil formulation and a non-emulsified cod liver oil formulation, each containing 10% cod liver oil plus 10% cod oil and closely matched DHA and EPA content. Blood samples were collected for 24 h after dosing to analyze DHA and EPA plasma concentrations using a validated methodology. DHA + EPA, DHA, and EPA pharmacokinetics were compared using an analysis of covariance model. The incremental area under the plasma concentration curve at 24 h (iAUC_0–24 h) for DHA + EPA was the primary endpoint.

Results: DHA + EPA, DHA, and EPA plasma concentrations reached higher levels in plasma following administration of the emulsified vs non-emulsified formulation. The emulsified cod liver oil formulation produced iAUC_0–24 h values for DHA + EPA, DHA, and EPA that were 1.66, 1.78, and 1.64 times higher, respectively, than the non-emulsified formulation; iAUC_0–10 h values were 1.84, 1.96, and 1.79 times higher, respectively (all p < 0.01). Maximum concentrations of DHA + EPA, DHA, and EPA in plasma were significantly higher for the emulsified than the non-emulsified formulation (p < 0.001).

Conclusions: DHA + EPA, DHA, and EPA plasma concentrations were significantly higher for the emulsified cod liver oil supplement vs the reference non-emulsified cod liver oil supplement.

Trial registration: ClinicalTrials.gov identifier: NCT02428699.

Keywords:

• Cod liver oil
• Docosahexaenoic acid
• Eicosapentaenoic acid
• Emulsion
• Omega-3 fatty acid
• Pharmacokinetics

Transparency

Declaration of financial/other relationships

NC and FvdB have no conflicts to disclose. NB-K is an employee of GlaxoSmithKline Consumer Healthcare Pte Ltd, Brentford, Middlesex, UK. GKD is an employee of GlaxoSmithKline Consumer Healthcare Pte Ltd, Singapore. A CMRO peer reviewer on this manuscript declares having conducted studies with different oil formulations looking at plasma concentrations. Other CMRO peer reviewers on this manuscript have no financial/other relationships to disclose.

Acknowledgments

Medical writing assistance was provided by Dennis Stancavish, MA, of Peloton Advantage and was funded by GlaxoSmithKline Consumer Healthcare.

Additional information

Funding

This study was funded and sponsored by GlaxoSmithKline Consumer Healthcare. GlaxoSmithKline Consumer Healthcare provided a full review of the article.