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.

第一种含有石榴籽油的用于肠道和免疫健康的医疗食品 Biotherapeutics Inc (BTI) 正在与 Pervida 品牌合作，开发经过临床验证的新型营养产品，以促进肠道和免疫健康。该 SBIR 应用的目标是开发石榴籽油 (PSO) 作为一种新型专有功能成分，并优化 PSO 成分在治疗炎症性肠病 (IBD) 的医疗食品中的剂量和组合效果。 意义。大多数功能性饮料缺乏能提供切实健康益处的成分。例如，益生菌是用于肠道健康的主要补充剂，然而，事实证明，大多数益生菌的细菌数量低、菌株多样性低，最重要的是，菌株生存能力低。大约有 60 至 7000 万人患有消化系统疾病，1.17 亿人因不良饮食习惯而患有可预防的慢性免疫疾病。其中，IBD 困扰着超过 300 万美国人和全球 500 万人。鉴于消化类医疗食品的功效有限，对经过临床验证的新产品的医疗需求尚未得到满足。 技术与产品。 Pervida 品牌推出了 Pervida Immune，这是一种富含维生素、抗氧化剂和 PSO 的淡碳酸饮料，不含糖或甜味剂，也是首款含有 PSO 的肠道和免疫健康产品。 Pervida Immune 有 3 种口味：柑橘口味、巴西莓口味和夏威夷芒果口味。 PSO 获得美国 FDA 的公认安全 (GRAS) 状态。该 SBIR 快速通道将开发 PSO 作为一种用于管理肠道和免疫健康的新型医疗食品。 此应用程序的具体目标是： (1) 对口服 PSO 进行局部和全身分布的 PK/PD 研究。 BTI 将测试一系列 PSO 浓度，以优化胃肠道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与 PUA 水平和功效的相关性。 (2) 评估 PSO 与其他成分之间潜在的转化协同作用。我们将确定，通过向来自健康受试者和 UC 患者的外周血单核细胞 (PBMC) 的口服产品中添加维生素（维生素 B12、B6、C 和 D），可以增强 PSO 的免疫和肠道健康益处。 商业应用：在本次研发工作结束时，我们将证明 PSO 是一种合理、安全且有效的营养成分，可调节肠道和免疫健康。含有 PSO 的产品将以我们的 Pervida 品牌进行营销，并进入 $15B 强化水市场、$9B 医疗食品市场以及 $15.2B 膳食补充剂市场。