Study design
RECRUITMENT
This study was a randomized, double-blind, parallel-design, single-center study conducted in accordance with local regulations, the International Conference on Harmonization E6 Guideline for Good Clinical Practice (GCP), and the Declaration of Helsinki. The study was sponsored by Nordic Naturals (Watsonville, CA) and conducted at Nutrasource Diagnostics (Guelph, Ontario). Ethical approval was obtained from an Institutional Review Board contracted by Nutrasource. The study was registered at ClinicalTrials.gov (Identifier #NCT02628483). Subjects were recruited in response to advertisements or from study site databases. Written, informed consent was obtained from all participants before any study-related activities. Recruitment began in March of 2016; the first subject was enrolled on March 15, 2016 and the last subject completed the study on December 8, 2016. The total intervention duration was 128 days, with two parallel groups: one group received a >96% TG form of N3PUFA (Ultimate Omega®; Nordic Naturals [UO]) and the other group received a <70% TG form of N3PUFA (MEG-3®, DSM Nutritionals, Heerlen, Netherlands [M3]).