The First Pomegranate Seed Oil-Containing Medical Food for Gut and Immune Health

第一种含有石榴籽油的用于肠道和免疫健康的医疗食品

• 批准号: 10010938
• 负责人: Raquel Hontecillas
• 金额: $ 29.55万
• 依托单位: BIOTHERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10010938
• 关键词: Address; American; Anti-Inflammatory Agents; Antioxidants; Bacterial Counts; Berry; Beverages; Biological Markers; Biological Response Modifier Therapy; Chronic; Citrus; Clinical; Clinical Research; Complementary and alternative medicine; Crohn' s disease; Diabetes Mellitus; Diet; Digestive System Disorders; Disease; Euterpe; Fatty Acids; Formulation; GTP-Binding Protein alpha Subunits, Gs; Goals; Hawaiian population; Health; Health Benefit; Histologic; Human; Human body; Immune; Immune System Diseases; Incidence; Inflammation; Inflammatory; Inflammatory Bowel Diseases; Interferon Type II; Linolenic Acids; Lipids; Mango - dietary; Medical; Mus; Nutritional; Obesity Epidemic; Oils; Oral; Oral Administration; Outcome; PPAR gamma; Patients; Peripheral Blood Mononuclear Cell; Phase; Pomegranate; Probiotics; Production; Punicic Acid; Seeds; Small Business Innovation Research Grant; Sweetening Agents; TNF gene; Technology; Testing; Ulcerative Colitis; United States; Vitamin B 12; Vitamins; Water; combinatorial; commercial application; cytokine; dietary supplements; dosage; immune health; inflammatory disease of the intestine; inflammatory marker; insulin sensitizing drugs; lipid mediator; medical food; mouse model; neutrophil; novel; pharmacodynamic biomarker; pharmacokinetics and pharmacodynamics; public health relevance; research and development; soft drink; sound; success; sugar; synergism; transcription factor

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.

第一个用于肠道和免疫健康的石榴籽含油食品 Biotherapeutics Inc（BTI）正在与Pervida品牌合作，开发新型临床证明的肠道和免疫健康营养产品。 SBIR应用的目标是将石榴籽油（PSO）开发为一种新颖的专有功能诱导，并优化PSO成分对医疗食品对炎症性肠病（IBD）的剂量和组合作用。 意义。大多数功能性饮料都缺乏提供切实健康益处的成分。例如，益生菌代表用于肠道健康的主要补充剂，但是，已经证明大多数益生菌的细菌数量低，菌株多样性低，最重要的是低应变生存能力。由于饮食不佳，大约有60至7000万人患有消化系统疾病，1.17亿人患有可预防的慢性免疫疾病。其中，IBD在全球范围内超过300万美国人和500万人。鉴于消化医疗食品的效率有限，因此对临床证明的新产品的医疗需求未满足。 技术和产品。 Pervida Brand推出了Pervida Immune，这是一种含有维生素，抗氧化剂和没有糖或甜味剂的PSO的轻度碳酸饮料，也是第一种用于肠道和免疫健康的含PSO的产品。 Pervida Immune有3种口味：柑橘，贝里·阿卡和夏威夷芒果。 PSO通常从美国FDA获得了通常被认为是安全的（GRAS）状态。这种SBIR快速轨道将开发PSO作为肠道和免疫健康管理的新型医疗食品。 此应用程序的具体目的是： （1）对口服PSO进行PK/PD研究，以进行局部和全身分布。 BTI将测试一系列PSO范围的PSO，以优化GI定位和全身分布的剂量。将评估包括细胞因子和脂质介质在内的药效生物标志物，以评估与PUA水平和效率的相关性。 （2）评估PSO与其他成分之间的潜在转化协同作用。我们将确定可以通过从健康受试者和UC患者中添加到外周血单核细胞（PBMC）中的口服血液单核细胞（PBMC）中的口服产物来增强PSO的肠道健康益处。 商业应用：在这项研发工作的结论下，我们将证明PSO是一种声音，安全且有效的营养诱导性，可调节肠道和免疫健康。含PSO产品的产品将在我们的Pervida品牌下进行销售，并进入15B美元增强的水市场，这是一个$ 9B的医疗食品市场，以及$ 15.2B的饮食补充剂市场。