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，而在以植物性饮食，特别是含有大豆的饮食为主食的国家，这些问题较少。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，可降低这些疾病的风险因素。 在人口统计学上多样化的临床研究受试者中遵守大豆饮食或在一般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，至少对于某些癌症，饮食改变可能需要终身，并在青春期之前建立。 在NCI资助的第一阶段研究中，我们成功地开发了一种感官吸引力的半商业化、大豆强化、富含芦荟酮的面食基质，在一份膳食中提供50 mg总芦荟酮，并在人体中进行了化学表征和生物评价。 在第二阶段研发的A部分，我们将优化配料配方和生产操作参数，以测试生产几种基于意大利面形式的大豆蛋白强化食品原型，随后将对其进行化学评估，以确定大豆蛋白的释放潜力。 然后将在绝经前和绝经后的女性、男性和分娩潜力中对食物进行3天的生物评价。 然后，将在绝经前和绝经后的女性、男性和儿童中对食物进行3天的生物评价，以确认其是否适合纳入基于大豆的商业轮换饮食。 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个要素进行进一步评价，以确认轮换饮食的连续递送的一致性。基于我们过去的成功，我们预测，这些生物评价研究将确认的有用性和商业潜力的制造的强化原型产品作为有用的研究食品。 这些2期研究将提高目前迫切需要的长期前瞻性饮食干预研究的成功可能性。 目前迫切需要通过长期前瞻性饮食干预研究进行临床评价。 研究人员的临床评估和流行病学数据的传播将鼓励全世界所有年龄段的人更广泛地使用这些产品作为促进健康的饮食选择，从而确保其商业成功。拟定商业应用：鉴于我们成功的第一阶段开发和对感官吸引力的大豆强化的人体测试，该大豆强化被证明能有效地提供生物学上有意义的量的膳食大豆异黄酮，这些膳食大豆异黄酮已被证明对健康有益，我们相信，拟议的第二阶段研究可以成功地测试生产并严格表征小范围的不同，方便的旋转大豆强化研究餐原型，最初将标记给临床研究人员，以帮助他们进行大豆健康益处的长期饮食干预研究。 这些II期研究的数据将证实产品的有效性，并将产生来自临床研究界和公众的巨大需求，从而确保产品过渡到III期商业化。

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.