Results of a randomized, double-blind, placebo-controlled, parallel group study on 89 healthy adults aged 18-65 (mean age 49) have been collated and the authors are now considering which peer-reviewed journal to approach with a view to trying to get it published.
The research, which was presented at The Gerontological Society of America’s 64th Annual Scientific Meeting last month, was led by clinical neuropsychologist Dr Gary Kay, associate professor of neurology at Georgetown University.
Kay is also president of Cognitive Research Corporation, a contract research organization specializing in diet and cognition, which conducted the six-week study. His aim is to submit the research for publication in the first quarter of 2012.
FOCUSfactor contains a blend of DMAE (dimethylaminoethanol – found in salmon, sardines and the human brain), the long-chain omega-3 fatty acid DHA, vitamins B12, B6 and D3, beta carotene, phosphatidylcholine, phosphatidlyserine, and the plant extracts Huperzine and Bacopa.
Unlike many cognitive function dietary supplements, claims made by FOCUSfactor were supported by research on the end product rather than extrapolations based on literature about individual ingredients, Kay told NutraIngredients-USA.
“This kind of research is expensive, and risky for the manufacturer as this product is already on the market, but the improvements in working memory we recorded were very exciting.”
While there were validated tests to assess working memory, subjective assessments in this area were notoriously unreliable, he said.
“It is actually very hard for people to accurately evaluate how their memory is functioning. It is more a reflection of our sense of self confidence than anything else.”
Consumer confidence in cognitive function market
Anthony Almada, president of consultancy IMAGINutrition, added: “You get a lot of products containing ingredients A, B, C and D in this market where people say, ‘Add key ingredient E to this and you have the magic of synergy’. But they haven’t done a study on the combination of ABCD and E.”
He added: “You could make the same argument about many dietary supplements and functional foods of course [where claims are frequently based on literature about individual ingredients rather than studies on the finishedproduct in question]. But I think there is a lot of hype and duplicity in this category.”
Consumers had also lost confidence in certain ingredients such as gingko because firms using extracts that were not the same as those used in clinical studies showing positive results were making unsubstantiated claims about extracts that were “chemically quite different”, he said.
RAVLT and Cog Screen
In the FOCUSfactor trial, Dr Kay used the Rey Auditory Verbal Learning Test (RAVLT), one of the most commonly used tests of memory in psychopharmacology research.
He also used CogScreen, a computer-administered neuropsychological test battery developed for the Federal Aviation Administration for evaluating the cognitive functioning of pilots and in clinical trials evaluating effects of treatments on cognitive functioning.
“The clinical study demonstrated that, compared to placebo, FOCUSfactor improved abilities referred to as memory, concentration, and focus in healthy adults,” he said.
“The most dramatic effects were seen on the initial learning trials of RAVLT and were confirmed by findings on the CogScreen measures of concentration and working memory.”
Improved word recall
He added: “Following six weeks of treatment, subjects who received FOCUSfactor had a mean increase in recall of 6.5 words compared to 4.5 words for those who received placebo.
“Subjects who received FOCUSfactor performed significantly better (p = 0.031) on a CogScreen measure of concentration / working memory than subjects who received placebo.”
Brain food, consumers and the future
While a lot of media attention has been given to ingredients claimed to arrest cognitive decline, the industry was still “years away” from drawing any firm conclusions in this area, said Almada, who stressed that products such as FOCUSfactor were targeted at healthy adults and could be tested using standardized, validated cognitive tests over relatively short periods.
Proving a preventative effect to ward off Alzheimer’s by contrast not only takes you away from supplement arena and into the drug realm, but would also require very different kinds of trials, he said.
Kay added: “What could enhance cognition may not necessarily have a neuroprotective effect.”
Brain food: What can consumers trust?
Speaking at the Supply Side East show in May, Datamonitor product launch analytics director Tom Vierhile said cognitive function was the functional foods category where the gap between interest and buying behavior was the widest.
While consumers were increasingly worried about losing mental acuity, they did not know which products to buy, he said.
But should clearer data emerge about which ingredients to back, the market opportunity was huge, he argued.
Dr Kay’s study was sponsored by Westbrook, Maine-based Factor Nutrition Labs, which sells the FOCUSfactor product and a range of other ‘brain health’ supplements including Omega Factor 3 and Omega DHA 900.
It is the first human intervention study on the supplement, which was the subject of a Federal Trade Commission probe in 2004 that led to charges that Creative Health Institute of Corinth, Texas, and its principal, Dr Kyl Smith were making unsubstantiated claims about its ability to improve users’ focus, memory, mood, and concentration.
Under a consent agreement with the FTC, the makers were prohibited from making any representation about the benefits of any supplements "for the brain or any mental functions or processes;unless the respondents possess and rely upon competent and reliable evidence substantiating that representation".
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