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.

第一个含补骨脂油的肠道和免疫保健药用食品 Biotherapeutics Inc（BTI）正在与Pervida品牌合作，开发新的经临床验证的肠道和免疫健康营养产品。这项SBIR应用的目标是开发石榴籽油（PSO）作为一种新型的专有功能成分，并优化PSO成分用于炎症性肠病（IBD）医疗食品的剂量和组合效果。 意义大多数功能性饮料缺乏提供有形健康益处的成分。例如，益生菌代表用于肠道健康的主要补充剂，然而，已经证明大多数益生菌具有低细菌计数，低菌株多样性，最重要的是，低菌株存活率。约有6000万至7000万人患有消化系统疾病，1.17亿人因饮食不良而患有可预防的慢性免疫性疾病。其中，IBD困扰着超过300万美国人和500万世界各地的人。鉴于消化医疗食品的功效有限，临床证明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，这是一种补充维生素，抗氧化剂和PSO的轻度碳酸饮料，不含糖或甜味剂，也是第一种含有PSO的肠道和免疫健康产品。Pervida Immune有3种口味：柑橘，浆果和夏威夷芒果。PSO获得了美国FDA的一般安全（GRAS）地位。SBIR快速通道将PSO开发为一种新型医疗食品，用于管理肠道和免疫健康。 本申请的具体目标是： （一） 进行口服PSO局部和全身分布的PK/PD研究。BTI将检测一系列PSO浓度，以优化GI定位和全身分布的剂量。将评价药效学生物标志物（包括细胞因子和脂质介质）与普阿水平和疗效的相关性。 （二） 评估PSO和其他成分之间潜在的翻译协同作用。我们将确定通过向健康受试者和UC患者外周血单核细胞（PBMC）中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：在这项研发工作结束时，我们将证明PSO是一种可靠，安全和有效的营养成分，可以调节肠道和免疫健康。含PSO的产品将以我们的Pervida品牌销售，并进入150亿美元的强化水市场，90亿美元的医疗食品市场，以及152亿美元的膳食补充剂市场。