ISOFLAVONE-RICH PASTA--CLINICAL AND COMMERCIAL POTENTIAL

癌症、心血管疾病和骨质疏松症仍然是美国的主要健康问题，而在植物性饮食，特别是含有大豆的饮食是主食的国家，这些问题不那么严重。现在有大量证据表明，饮食中的大豆异黄酮是有益的激素调节剂，负责减少这些疾病的风险因素。在人口统计学不同的临床研究对象中遵守大豆饮食或在普通人群中改变饮食是可取的，但不太可能通过使用传统的大豆食品(如豆腐)来实现，特别是因为有证据表明，至少对某些癌症来说，饮食改变可能需要终生的，并在青春期之前确立。在NCI资助的第一阶段研究中，我们成功地开发了一种具有有机感官吸引力的半商业、大豆强化、富含异黄酮的意大利面基质，在单餐大小的一份中提供了50毫克总异黄酮，并对其进行了化学表征和人体生物评估。在他的第二阶段研发的A部分，我们将优化成分配方和生产操作参数，允许基于辅助面食格式的几种大豆异黄酮强化食品原型的试制，随后将对其进行异黄酮输送潜力的化学评估。然后将在3天内对绝经前和绝经后的女性、男性和分娩潜力进行生物评估。然后，将在3天内对绝经前和绝经后的妇女、男子和儿童的食物进行生物评估，以确认它们是否适合纳入商业大豆轮换饮食。每种成功表征的原型食物将作为成人36天食物轮换研究的一部分进行进一步评估，以确认轮换饮食中异黄酮类递送的一致性。根据我们过去的成功，我们预测这些生物评价研究将证实所制造的强化原型产品作为有用的研究食品的有用性和商业潜力。这些第二阶段研究将增加目前迫切需要的长期前瞻性饮食干预研究的成功可能性。通过长期前瞻性饮食干预研究进行临床评估，这是目前迫切需要的。研究人员的临床评估和出现的流行病学数据的传播将鼓励更广泛地使用这些产品，将其作为全球所有年龄段的人促进健康的饮食选择，从而确保它们的商业成功。拟议的商业应用：鉴于我们成功地进行了第一阶段的开发和人体测试，我们成功地开发了一种具有有机感官吸引力的大豆强化产品，并对其进行了人体测试，事实证明，该产品有效地提供了具有生物学意义的大豆异黄酮类食品，并证明了这些大豆异黄酮对健康有好处。我们相信，拟议的第二阶段研究将成功地测试、制造并严格表征一小系列多样化、方便的旋转大豆强化研究膳食原型，这些原型最初将被标记给临床研究人员，以帮助他们进行长期的大豆健康益处饮食干预研究。这些第二阶段研究产生的数据将证实产品的有效性，并将产生临床研究界和公众的巨大需求，从而确保产品过渡到第三阶段商业化。

Cancer, cardiovascular disease and osteoporosis remain the major health problems in the US whereas they are less problematic in countries where plant-based diets, especially those containing soybeans are a staple. Substantial evidence now exists implicating dietary soybean isoflavones as beneficial homone-modulators responsible for reducing the risk factors for these diseases. Compliance to a soy-based diet in demographically diverse clinical research subjects or dietary changes in the general population is desirable but unlikely to be achieved by use of traditional soy-based food, such as tofu, especially since evidence suggests that for some cancers at least, dietary change may need to be lifelong and established before puberty. During Phase I studies, funded through the NCI, we successfully developed, chemically characterized and bioevaluated in humans, an organoleptically appealing semi-commercial, soy-fortified, isoflavone-rich pasta matrix, that supplies 50 mg total isoflavones in a single meal-sized portion. In Part A of his Phase 2 R&D, we will optimize ingredient formulations and production operating parameters allowing the test manufacture of several soy isoflavone fortified food prototypes based on the ailmentary pasta format which will subsequently be chemically evaluated for isoflavone delivery potential. Foods will then be bioevaluated over 3 days in pre- and postmenopausal women, men and delivery potential. Foods will then be bioevaluated over 3 days in pre- and postmenopausal women, men and children to confirm their suitability of inclusion in a commercial soy-based rotation diet. Each successfully characterized prototype food will be further evaluated as an element of a 36 day food rotation study in adults, to confirm the consistency of isoflavone delivery of the rotation diet. Based on our past success, we predict that these bioevaluation studies will confirm the usefulness and commercial potential of the manufactured of-fortified prototype products as useful research foods. These Phase 2 studies will enhance the likelihood of success for long-term prospective dietary intervention studies which are now urgently required. Clinical evaluation by long-term prospective dietary intervention studies which are now urgently required. Clinical evaluation by researchers and dissemination of the epidemiological data that emerges will encourage wider use of the products as health promoting dietary choices for people of all ages worldwide, thereby ensuring their commercial success. PROPOSED COMMERCIAL APPLICATION: In light of our successful Phase 1 development and human testing of an organoleptically appealing soy-fortified that was shown to efficiently delivery biologically meaningful amounts of dietary soy isoflavones that have proven health benefits, we are confident that the proposed Phase 2 studies can successfully test manufacture and rigorously characterize a small range of diverse, convenient rotational soy-fortified research meal prototypes that will be marked initially to clinical researchers to aid them in their long dietary intervention studies of the health benefits of soy. The data emerging from these Phase 2 studies will confirm the validity of the products and will generate enormous demand from the clinical research community and public, thereby ensuring transition of the products to Phase III commercialization.