KGK Science publishes new measures of cognitive function for supplements RCTs

By Stephen Daniells contact

- Last updated on GMT

© Getty Images / nevarpp
© Getty Images / nevarpp
A new global index that combines endpoints from studies of dietary supplements for brain health may help to scientifically validate claims being made on products, says its developers at KGK Science.

The KGK scientists sought to understand if existing tools and biomarkers can confidently support the efficacy of nootropics in the nutraceutical industry, and after finding little to no comprehensive measures that capture cognitive function, they developed the the concept of the Global Index for Cognitive Function.

The goal of the Cog-GI (Cognitive Global Index), which is described in Translational Neuroscience​, is to shift to a concept that is more encompassing of several outcomes rather than with single tests alone to be able to provide better results longitudinally, and identify and track cognition improvement.

“The gold standard randomized controlled clinical trials provide the casual inference necessary to define the efficacy of emerging nutraceuticals,”​ stated Dr Mal Evans, scientific director of KGK Science, and co-author on the paper.

“Our industry should focus on controlled studies that step away from the one-drug-one-disease concept of the pharmaceutical model to one that better encompasses multiple positive effects elicited by dietary supplements. Global indices of health may be appropriate in capturing the positive effects of dietary supplements and functional foods, and give a study the best chance at receiving favorable results.”

Beyond the MMSE

Cognitive health is a broad and nuanced field, particularly for research using healthy participants and dietary supplement interventions, where the changes may be subtle but still significant. There are many aspects of cognitive function that can be assessed, from immediate and delayed recall to measures of attention, and from verbal skills and fluency to measures such as executive function.

To date, most randomized clinical trials of dietary supplements for cognition in health subjects have relied on the mini mental state examination (MMSE) to measure cognitive performance. However, the authors of the new paper explain that is actually a measure of cognitive impairment.

A recent report from Research and Markets pegged the global market for brain health supplements at US$ 2.3bn in 2015, and predicted it to hit $11.6bn by 2014 (a CAGR of almost 20%).

“RCTs evaluating dietary supplements generally use MMSE to determine the outcome of cognition testing in a healthy population. Due to the inherent weakness of using MMSE in a clinically healthy population, there has been a shift towards use of computerized battery of tests that have been validated to identify the subtle differences experienced with the use of dietary supplements,” ​wrote the authors.

“Evidence indicates that tests detecting subtle differences exerted by dietary supplements offer better and validated alternatives to test cognition. Composite endpoints identified from tests of cognition, together with physiological, psychological and emotional biomarkers that can be influenced by nutrients and efficacy studies should comprise a global index, which must be validated in RCTs for the dietary supplement industry.

“It is plausible that combining endpoints to form a global index will help in scientifically validating claims to provide accurate science behind supplements and to meet the regulatory requirements for their substantiation,”​ they concluded.

The importance of clinically relevant endpoints

“Our team has been working hard for the past year on developing this index,” ​said Najla Guthrie, president and CEO of KGK Science, and co-author of the new paper. “With our speciality being in the supplement, functional food, ingredient, and cosmetic industry, we understand that one of the best chances to achieving statistical significance in a study is to have clinically relevant endpoints. As we know from our 20 years of experience, this comes with its challenges in nutraceutical research. 

“We see this Global Index as the starting ground to changing how our industry looks at nutraceutical research.”

Source: Translational Neuroscience
2017, Volume 8, Pages 87–96, doi: 10.1515/tnsci-2017-0014
“The Essentials of a Global Index for Cognitive Function”
Authors: J.M. Antony, et al.

 

 

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