“We have seen an increase in requests for nootropic studies over the past 3-5 years,” Josh Baisley, B.Sc., director of clinical trials at Nutrasource, told NutraIngredients-USA.
The lab he works for is an Ontario-based full contract research organization that helps companies with regulatory compliance, clinical trials, and product testing. A key part of the business is claims substantiation to help companies bring products to market with strong science and regulatory confidence.
According to Baisley, the side effects of pharmaceutical agents for cognitive decline—like the potential abuse of its addictive nature—is a big component of the rise of demand for dietary supplement nootropics.
“There is [also] a lack of effective pharmaceutical therapies for more severe conditions such as dementia and Alzheimer’s which appear more prevalent due to the aging population,” he explained. This in turn has boosted demand for preventive natural products and dietary supplements from consumers, he added.
Another Ontario-based lab, KGK Science, noted the same upward trend for nootropic product testing. Dr. Mal Evans, scientific director at KGK Science, said that it’s very much a consumer-driven trend.
“The changes are also a reflection of the 21st century North American population,” she told us. “Cognition and stress is an issue with baby boomers becoming a sandwich generation, the transient nature of jobs, and the demand for keeping up with the ever-changing face of technology.”
“The term ‘nootropic’ by definition is a compound that increases mental functions including memory, motivation, concentration, and attention,” said Josh Baisley, B.Sc., director of clinical trials at Nutrasource, citing a 2008 study published in Pharmacological Research.
It is often linked to products associated with terms such as ‘brain booster’ or ‘memory enhancing’ or ‘increases mental energy.’
A Romanian scientist who was researching the pharmaceutical nootropic piracetam, Corneliu Giurgea, coined the term in 1972, combining the Greek words for ‘mind’ and ‘bending.’
“Caffeine and Gingko are often thought of as Nootropics in dietary supplements but drugs like Nicotine and Ritalin, and Adderall are also technically considered Nootropics. The recent direction in the category is to get away from potentially addictive substances that have unwanted side effects, so the emphasis has been on the natural ingredients,” Baisley added.
So how do you prove the efficacy of a nootropic supplement?
Using the randomized controlled trial (RCT) model has been a gold standard for nootropic testing, but Evans said that the model has led to unfruitful trials concluding that the interventions were ineffective, “while in fact, the trial design was inadequate to substantiate a claim leading to higher proportions of false negatives.”
“Over the last 20 years, designing clinical studies, KGK researchers have recognized that a global index would be a better measure of the efficacy of supplements vs. the singleton primary endpoint model that originates from the pharma industry,” she said.
In December last year, the company announced the Cog-GI (Cognitive Global Index), a new global index that combines endpoints from studies of dietary supplements for brain health published in the journal Translational Neuroscience.
Since its announcement, the lab has been promoting the global index in the supplement space through conversations with study sponsors and potential customers explaining the appropriateness of the method for dietary supplements.
“While the RCT model is important to ably measure causal effects and to address confounding of a supplement, the multifaceted nature of supplements and multi-targeted outcomes are not measurable within the scope of a single endpoint,” Evans said.
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“Global indices of health are appropriate in the nutrient realm since functional foods and dietary supplements do not fit into the pharmaceutical model.”
A shift from RCTs to a global index isn’t merely for statistical convenience, Evans argued. Researchers would be able to capture the improvements elicited due to nutrients or supplements and to improve a health indication.
“Identifying a global index that encompasses all these outcomes and summing the effects of a nutrient across systems will better reflect the functional role that nutrients play better than from a single outcome measure and may help avoid potentially improper failure of clinical trials due to high rates of type II error (false negatives),” she explained.
For Nutrasource, nootropic supplement study designs would depend on the product’s proposed mechanism of action as well as its target population.
“In other words, is it a sports nutrition product to address mental focus, motivation, mental energy or is it intending to market to enhance cognitive function in elderly,” Baisley said.
“Different natural nootropics currently in the market and potentially being developed have different mechanisms, and thus affect different parameters.”
A thorough review of existing literature would need to be conducted to assess the most commonly used reliability and validity tested methods, he added.
“It is very important to have a clearly defined population and to be very specific as to what you are targeting as this will dictate the studies and tests done in those you can use for substantiation as well as which ones to use in your own study design.”