Illinois-based nutraceuticals expert VDF Futureceuticals has embarked on a larger human trial of its whole coffee fruit concentrate NeuroFactor after a pilot study showed it increased plasma levels of Brain-Derived Neurotrophic Factor (BDNF) by an average of more than 140%.
BDNF is a protein active in the brain and central and peripheral nervous systems that plays a key role in neuron development and repair and in protecting against neuro-degeneration.
It is also believed to be important for learning, memory, alertness, mood, controlling body weight and energy metabolism, and increases in response to exercise; while low levels have been associated with obesity, diabetes, depression and Alzheimer's.
The most important aspect of the Futureceuticals pilot study was that NeuroFactor was tested against other extracts touted as having cognitive health benefits, including green coffee bean extract powder, green coffee caffeine powder and grape seed extract powder, the firm's director of marketing Brad Evers told NutraIngredients-USA.
"But only NeuroFactor [a patented product from the whole fruit of the coffee plant, Coffea arabica] showed a statistically significant ability to increase BDNF in humans."
“There was a huge difference in terms of changes in baseline BDNF levels between NeuroFactor and coffee caffeine, for example, so we know the effect is not just about caffeine or coffee,” he added.
We know the effect is not just about caffeine or coffee
While the pilot study is still awaiting publication (it is currently in-press at the British Journal of Nutrition), FutureCeuticals decided to promote NeuroFactor at the Supply Side West trade show last month in order to gauge interest, said Evers.
“The pilot study was a double-blind, placebo-controlled study, but it only had 10 people, so we are now are in the midst of a [new, larger] double-blind, placebo-controlled, acute crossover study to verify its on levels of BDNF in clinico.
"We expect to finalize the study and submit for publication in early Q1 2013."
He added: "The results of the pilot were so significant - everyone in the trial had significantly raised levels of BDNF in their blood - that we wanted to dig more into it, and see what kind of feedback we got.
"From our conversations, it is clear that awareness and interest in BDNF as a marker of biological significance, particularly with regard to cognitive function, is increasing."
We are still investigating the role of BDNF as it pertains to exercise
But there could also be sports nutrition applications, he speculated.
"We are still investigating the role of BDNF as it pertains to exercise. We know based on the literature that they are correlated; as a result we are looking into possibilities associated with recovery and/or endurance for NeuroFactor."
He added: “It’s early days but I think Neurofactor has potential in several areas. Cognitive benefits, sports recovery, increasing response to exercise. We’d like to do a study looking at recovery times or endurance to try and understand how to position it in the sports arena.
“In 2010-2012, there have been seven or eight significant studies looking at BDNF increases in response to exercise. At this stage, however, our primary goal is to confirm NeuroFactor's ability to increase BDNF in vivo."
NeuroFactor, which is GRAS, is soluble with a neutral taste, making it suitable for food and beverage as well as supplement applications, he said.
Pilot human study
In the pilot study, randomly assorted groups of fasted subjects consumed a single, 100 mg serving of each material.
Plasma samples were collected at 30 minute intervals up to 120 minutes. Two control groups were included: Subjects treated with silica dioxide (as placebo) or with no treatment, said Evers.
"Though increase was unanimous in the NeuroFactor group, response times appear to be very individual-specific. Based on our data from the first pilot clinical, we tended to see a peak at approximately 60 minutes.
"Though we have not yet studied chronic use of NeuroFactor, published research is clear on the fact that BDNF increases in response to exercise, a very encouraging fact given the benefits of exercise. Moreover, the bulk of research on BDNF consistently points to the potential detriments associated with low BDNF levels.
"Several new product development initiatives can be attributed to the unanimous and unique response in the NeuroFactor group. Publication of our second set of results will only bolster these, and other, initiatives."