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Harsh SanchetiHarsh Sancheti is a doctoral candidate at the University of Southern California under the mentorship of Enrique Cadenas, Ph.D. He has also completed a master’s in pharmaceutical sciences and a master’s in regulatory sciences and is the current chair-elect of the AAPS BSSC.

Nutraceuticals” is defined as, “food or parts of food that provides medical or health benefits, including the prevention and treatment of disease.” It has been the umbrella term for several other terminologies such as medical foods, functional foods, nutritional supplements, and dietary supplements. The global nutraceuticals market reached $142.1 billion in 2011 and is expected to reach $204.8 billion in 2017. More importantly, there has been a paradigm shift in our concept of nutraceuticals since we have moved from viewing nutraceuticals as means for, ”providing adequate nutrition” to ”avoiding deficiency states,” and now finally onto ”preventing or treating chronic diseases.” This has been made possible due to the constantly accelerating pace of research in nutraceuticals.

Over the years, a very interesting aspect of nutraceuticals has been its effect on the brain and how they counter neurological conditions. The cognitive functioning of the brain primarily relies on the high-energy, demanding neurons; conversely, imbalance in energy supply to the neurons is being implicated in aging and several age-related neurological conditions like Alzheimer and Parkinson disease. Lipoic acid, a nutraceutical with redox modulating properties, has been shown to restore the energy deficits in Alzheimer disease and promises to have beneficial effects in preventing the neurodegeneration associated with Alzheimer disease. It has been tested in preclinical models and through small scale clinical trials. Additionally, acetyl-l-carnitine, the nutraceutical form of carnitine, assists in energy production by breakdown of fatty acids and has been shown to improve cognitive function in preclinical animal models and small scale clinical trials. Vitamin E is essential for normal neurological function; tocotrienols, one of the eight naturally occurring and chemically distinct vitamin E analogs, displays neuroprotective activity. Moreover, research shows the utility of using several naturally occurring polyphenolic compounds such as phytoestrogens in brain health by maintaining and/or restoring cognition12. A phytoestrogenic combination of genistein, daidzein, and R/S-equol was found to be neuroprotective in Alzheimer disease. Several B vitamins have well established roles in maintaining healthy cells. Moreover, common dietary polyphenols have the ability to suppress neuroinflammation, promote memory, learning, and cognitive functions.

In spite of the multiple potential benefits of several nutraceuticals, a large number of nutraceuticals still need to be validated thoroughly as bulk of the scientific evidence is derived from in vitro assays and animal testing, whereas, human clinical trials are scarce and inconclusive due to small size or poor design. To thoroughly validate the particular nutraceutical in treating a chronic condition, issues like bioavailability, metabolism, dose/response and toxicity also needs to be ascertained. Moreover, the regulation of nutraceuticals by the different regulating agencies has been inconsistent, if not confusing. Certain countries classify nutraceuticals as drugs, with government-approved health claims, while others do not1. The Food and Drug Administration regulates nutraceuticals under dietary supplements and its regulation is mainly limited to health claims but needs the manufacturer to ensure its safety.

Overall, the several advances in nutraceutical research to date needs to be applauded; however, validating them thoroughly and having consistent regulations would be the next important steps.