Effect of the interaction between Ahiflower® oil and Icosapent-ethyl ester (IPE) on pharmacokinetic aspects associated to the EPA concentration.

• Grant number: 25/26940-7
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: February 01, 2026
• End date: January 31, 2027
• Field of knowledge: Health Sciences - Nutrition - Nutrition Biochemistry
• Principal Investigator: Inar Castro Erger
• Grantee: Camila Souza Teixeira
• Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Cardiovascular disease (CVD) remains the leading cause of mortality worldwide, and despite advances in lipid-lowering therapy, residual cardiovascular risk persists. Supplementation with eicosapentaenoic acid (EPA), particularly as icosapent-ethyl (IPE), has demonstrated significant reductions in major adverse cardiovascular events (MACE). However, IPE is costly, derived from marine sources, and environmentally unsustainable. Ahiflower® oil (Buglossoides arvensis), rich in stearidonic acid (SDA) and ¿-linolenic acid (ALA), offers a plant-based alternative that efficiently increases endogenous EPA levels, although at a lower magnitude than direct IPE supplementation. This project investigates whether the combined administration of Ahiflower® oil and IPE can reduce the required IPE dose while maintaining similar plasma EPA concentrations and pharmacokinetic profiles. A randomized clinical trial will be conducted with healthy volunteers (n = 45; 15 per group) receiving IPE, Ahiflower® oil, or a combined IPE + Ahiflower® regimen for 28 days. Fatty acid profiles in plasma and erythrocytes will be quantified by GC-MS Pharmacokinetic parameters will be determined using PKanalix® and modeled by population pharmacokinetic analysis in MonolixSuite®. Anthropometric and biochemical variables will also be monitored to assess safety and metabolic responses. The study aims to elucidate whether partial substitution of marine-derived IPE with sustainable plant-derived Ahiflower® oil preserves EPA bioavailability and therapeutic potential, thereby supporting more accessible and environmentally responsible strategies for omega-3 supplementation in cardiovascular prevention. (AU)