2013 Annual Report
1a.Objectives (from AD-416):
The primary objective of this investigation is to determine the relative percentage and rate of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total omega-3 (n-3) fatty acids after ingestion of emulsified flavored triglyceride fish oil supplements (Coromega Squeeze™, Coromega Nectar™, and Barlean Swirl™) versus pure encapsulated triglyceride (Nordic Naturals Omega-3 Softgels™) in defined plasma lipid pools.
The primary endpoints to be evaluated include the fatty acid composition of plasma lipids before and after consumption of a single dose of emulsified triglyceride based fish oils and triglyceride of similar n-3 compositions in capsule form. We will measure changes in plasma total, phospholipid, and chylomicron fatty acids.
1b.Approach (from AD-416):
A randomized and crossover design will be employed to compare absorption kinetics of EPA, DPA and DHA in 10 subjects consuming of Coromega Squeeze™, Coromega Necta™r, Barlean Swirl™ emulsified or the equivalent of the parent oil, Nordic Naturals Omega-3 fish oil™. Study subjects will include healthy adults between the ages of 18 to 60. The supplemental doses will be designed to provide equivalent amounts of EPA, DPA and DHA.
Study subjects will randomly receive fish oil as either the Coromega Squeeze', Coromega Nectar' , Barlean Swirl' (to match EPA), or Nordic Omerga-3 Softgel' supplements after an overnight fast. Whole blood samples will be drawn at baseline, immediately prior to supplementation, and at 2, 4, 8, 24 and 48 hours post supplementation. Food will be restricted during the first 8 hours following the administration of test articles. Following the 8-hour sample, subjects will be allowed to return home and consume a low fat diet devoid of long chain omega 3, i.e., no fish meals or eggs until the 48 hour sample has been drawn. The subjects will again be asked to fast overnight and return to the center for the 24 and 48 hour sampling, respectively. The second arm of the study will be repeated 6 weeks following the initial arm to guarantee adequate washout. Subjects will be asked to consume a low n-3 diet between testing periods and will be provided dietary guidance on foods to avoid. Subjects will be asked to complete a "Tolerance Questionnaire” 4 hours after consumption of the fish oil supplement.
46 participants applied for online for the study. Of those 19 completed consent and were screened for study participation. – 3 did not show up for 1st visit; 2 did not qualify after screening; 4 declined participation due to schedule conflicts. 10 subjects completed all aspects of the trial. The fatty acid analysis is currently being conducted. When received, data will be analyzed and manuscript(s) prepared for publication.
ARS PI monitoring activities to evaluate research progress included: phone calls/ conference calls, email communications, discussions at professional conferences/ meetings, and review of Accomplishment Report.