Interviewer: So just in summary and the studies that you've done, you've tested BDNF levels just through a simple blood test is that, how that you have been able to do that?
John Hunter: Correct.
John Hunter: What we do is for many of our studies, we've based a lot of our work on acute changes in the human body and we can do that because our company produces fruit, vegetable and grain based materials. We are not dealing in drugs or OTCs, any kind like that.
So we go directly into people. We don't do animal studies. We don't do in vitro studies. We don't really think they necessarily prove anything. It's what happens when you ingest it and then what we do is we'll ask our study participants to not eat anything after midnight they come in fasted, we do a baseline blood draw, after which they ingest the tested material and over the course of the next four to six hours, we do periodic blood draws. Often times it's sufficient to do a finger stick.
John Hunter: You know, take a few milliliters of blood or in other cases, we need a little more so we go into the venous supply and then we can run all sort of analysis from then. And from what we do, then we crunch the data and look for changes.
Interviewer: And in terms of what people might feel after couple of weeks or months or longer on this is that something that's still kind of ongoing is that correct then.
John Hunter: Well, the promise is that all of these gene expressions are switches. For example, the active form of Vitamin D Calcitriol, you can take all of Vitamin D you want, but it only becomes really useful when it's converted in your body into Calcitriol. But you wouldn't want your Calcitriol levels to go up and stay up, because Calcitriol over a time can be toxic.
Calcitriol is a signaling or a trigger mechanism, it goes up it spikes and it goes back down, but it initiates a whole cascade of healthy beneficial events downstream. Same thing with BDNF. The promise here was that we are trying to stimulate the BDNF gene to express and temporarily cause a spike in the level of BDNF and the theory is then downstream benefits will occur. So we haven't done any long term studies in terms of that, but these new studies are going to be, you know longer duration, a week, two weeks, a month and we will see if there are changes there.
Interviewer: You talked a little bit about toxicity of a certain products. Talk about the safety of neural factor and the dosing as well and what you've determined there.
John Hunter: Sure.
Interviewer: A lot of people think well, if it's from a natural product then [inaudible 00:03:13] must be better, you know.
John Hunter: Yeah,
Interviewer: What have you done so far?
John Hunter: Contrary to what our industry has always thought and I think a lot of its driven by western thought that anything worth doing is worth overdoing. We've discovered that less is often more. And certain antioxidant products, certain products that cause expression of certain genes.
We've found that if you increase the dose beyond a certain point, you actually cause things to start shutting down. So we do dose response studies to try and optimize what might be the best target serving range and then we also do toxicology studies. For example, on our coffee fruit extract this neural factor we are talking about, we've spent 18 months of long term toxicology studies, we looked at everything from neurogenecity to cytotoxicity we did you know, full necropsies, checking out how livers, kidneys, hearts, lungs, brains were affected.
We've brought in qualified toxicologists and published a paper on the safety of this material and actually it self-affirmed GRAS at this point. So we are quite confident of the safety of it and we're really pleased to give the report that all of the activity we are seeing is only at a 100 mg per survey. So it's very small, which is you know a really good thing.