Abstract
Long-chain omega-3 polyunsaturated fatty acids (LC-ω3 PUFA), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), play key roles in physiological functions and disease prevention. The nutrient gap in meeting LC-ω3 intake recommendations in the U.S. and globally can be addressed by alternative sources of LC-ω3. This randomized, placebo-controlled, seamless phase I/II study evaluated the pharmacokinetics, safety, and efficacy of a transgenic LC-ω3-rich canola oil in healthy adults. Participants (n = 33/group) were randomized to receive low-, mid-, or high-dose of the LC-ω3-rich oil (providing 285, 570, or 1,140 mg LC-ω3 PUFA, respectively) or placebo (corn oil). After one dose, plasma ω3 (primary outcome) levels were assessed over a 72 h pharmacokinetic period. Whole blood and red blood cells (RBC) ω3 and serum cardiovascular biomarkers were assessed during a 16-week continuation period with daily supplementation. Compared to low-dose and placebo, high-dose group showed greater DHA AUC0−72h and Cmax. A linear response was observed for DHA and EPA AUC0−72h. Compared to placebo, high- and mid-dose groups showed increased whole blood DHA, EPA, α-linolenic acids (ALA) (high-dose only), omega-3 score, and omega-3 index after 4 weeks, and increased DHA and EPA in RBC after 16 weeks (P < 0.05). No changes in cardiovascular biomarkers were seen. Overall, this LC-ω3-rich oil demonstrated good DHA bioavailability and significantly improved short and long-term blood LC-ω3 profiles. Sixteen weeks of daily supplementation of the LC-ω3-rich oil was safe and well-tolerated.
Highlights
Fats and fatty acids are considered key nutrients affecting both early growth and development, as well as nutrition-related chronic diseases later in life
A total of 132 participants who passed the screening were randomized in a 1:1:1:1 ratio into the four study groups, each containing 33 participants who received one of the three different doses of test product (TP) or placebo
Five participants were removed from the study due to non-compliance; the remaining participants were compliant to the study procedures
Summary
Fats and fatty acids are considered key nutrients affecting both early growth and development, as well as nutrition-related chronic diseases later in life. The blood lipid and fatty acid profiles play critical roles in human health and they can be modulated by dietary changes, such as increasing long-chain omega-3 polyunsaturated fatty acid (LC-ω3 PUFA) intake [1]. There is a large nutrient gap between the current dietary intake, ∼80–110 mg/person/day, of LC-ω3 PUFA [i.e., docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)] in the U.S population [4–7] and the in take guidelines of 250–500 mg/day for healthy adults [8, 9]. Increased awareness of the role LC-ω3 PUFA play in human health and disease risk drives a growing interest. The global demand for LC-ω3 PUFA exceeds 1.27 million tones per year, based on the most commonly recommended dose for cardiovascular health (500 mg/person/day) by the Global Organization for EPA and DHA Omega 3s (GOED) [10]. The supply is estimated at 0.2 [11] to 0.8 [12] million tones per year from the ocean highlighting a shortage of more than 0.4–1 million tones [12]
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