The First Pomegranate Seed Oil-Containing Medical Food for Gut and Immune Health Biotherapeutics Inc (BTI) is partnering with the Pervida brand to develop novel clinically proven nutritional products for gut and immune health. The goals of this SBIR application are to develop pomegranate seed oil (PSO) as a novel, proprietary functional ingredient and to optimize dosage and combinatorial effects of PSO components for medical food products for inflammatory bowel disease (IBD). Significance. Most functional beverages lack ingredients that provide tangible health benefits. For instance, probiotics represent the main supplements used for gut health, however, it has been demonstrated that most probiotics have low bacterial counts, low strain diversity, and most importantly, low strain survivability. About 60 to 70 million people suffer from digestive disorders and 117 million have preventable chronic immune diseases due to poor diet. Of these, IBD afflicts over 3 million Americans and 5 million people worldwide. Given the limited efficacy of digestive medical foods, there is a unmet medical need for clinically proven new products. The Technology & Product. Pervida brand has launched Pervida Immune, a lightly carbonated drink supplemented with vitamins, antioxidants and PSO with no sugar or sweeteners, and the first PSO-containing product for gut and immune health. Pervida Immune is available in 3 flavors: Citrus, Berry Acai and Hawaiian Mango. PSO obtained Generally Regarded as Safe (GRAS) status from the U.S. FDA. This SBIR Fast-Track will develop PSO as a novel medical food for the management of gut and immune health. The Specific Aims for this application are to: (1) Perform a PK/PD study of oral PSO for localized and systemic distribution. BTI will test a range of concentrations of PSO for optimization of dosage for GI localization and systemic distribution. Pharmacodynamic biomarkers including cytokines and lipid mediators will be evaluated for correlation to PUA levels and efficacy. (2) Evaluate potential translational synergisms between PSO and other ingredients. We will determine is immune and gut health benefits of PSO can be enhanced by addition of vitamins (vitamins B12, B6, C and D) to the orally administered products in peripheral blood mononuclear cells (PBMCs) from healthy subjects and UC patients. Commercial Application: At the conclusion of this R&D effort we will have demonstrated that PSO is a sound, safe, and effective nutritional ingredient that regulates gut and immune health. PSO-containing products will be marketed under our Pervida brand and enter a $15B enhanced water market, a $9B medical foods market, plus a $15.2B dietary supplements market.