This Small Business Innovation Research (SBIR) Phase II project will use state-of-the-art assays to detect estrogenic activity (EA) and anti-EA in antioxidants (AOs). Chemicals like AOs that have EA or Anti-EA (EA**) produce adverse health effects, including reproductive and behavioral disorders and some cancers. AOs have not been examined for EA**, much less AO packages reformulated to have specific levels of EA for specific commercial applications. This project will assess the EA** of 10 additional organic AOs, and 15 EA-**Free/EA**-specified formulations made from combinations of conventional, organic, water-soluble, and oil-soluble AOs that are stable when exposed to common-use stresses. These AO formulations will be used by identified partners to produce animal feeds, cereals and other foodstuffs that are EA**-free or have well-specified levels of EA** providing a clear path to commercialization and additional patents.
The broader impacts of this research are that fetal or juvenile mammals, including humans, are especially sensitive to chemicals having EA** at very low dosages and should not indiscriminately ingest such chemicals. Conversely, other conditions (e.g., menopausal symptoms, some cancers or abnormalities of the prostate) are ameliorated by chemicals having controlled levels of EA**. Hence, this project will minimize the risks of unintentional consumption of chemicals having EA** by using EA**-free AOs in products such as cereals and baby formulas or specified-EA** AOs in products such as fitness drinks and dietary supplements for post-menopausal women.
The objective of this study is to use state-of-the-art assays to detect estrogenic activity (EA) and anti-EA in antioxidants (AOs) and to minimize the risks of unintentional consumption of chemicals having EA or ant-I EA (EA**) by developing EA**-free AOs. This project is significant because many entities, including some government agencies, recognize the potential adverse effects of EA** that have been shown in laboratory animals and/or humans, including abnormal brain maturation, decreased sperm counts, ovarian and uterine disorders, reduced fertility, learning disabilities, disorders of attention, emotion and cognitive development, and increased incidence of some cancers of the breast, testes, and ovaries. Avoiding or diminishing unintentional exposure of EA**, especially at young ages, could greatly benefit the society. CertiChem (CCi) has developed a set of food antioxidants and antioxidant formulations that are now commercially available. In order to decrease the cost and increase the volume of the testing for consumers’ products, CCi has also improved the efficiency and the throughput of CCi’s robotic assays to detect EA** in assays using both MCF-7 and BG1 cells. CCi has published 5 peer-reviewed papers in the past year in the field of in vitro assay development and the assessment of EA** in consumer products such as plastics, cosmetics, etc. CCi’s studies have received much attention from the general publics, governmental agencies and commercial entities.
