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.
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.
