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Research That Supports BonOlive's Benefits
Interviewer: Can you talk about specific studies, research on BonOlive and what some of the results have shown?
Sam Possemiers, PhD: BonOlive has in fact been studied in over 20 different studies. Those studies ranged from cell culture studies, which means that they take cells from humans and they really put the active compound in combination with the cells and they looked at the development of these bone-forming cells. So that's really taking it in its most simple approach. You take the cell, you put the compound and you see what is the result. Of course, this is an isolated investigation. You don't really know what will happen with bone formation. So that's why a number of animal studies were also performed. In these animal studies you work with a rat model which develops osteoporosis. So it's a very well known and well established model. If you don't treat the animal with a test product, it will spontaneously develop osteoporosis.
So we use this well-known model to give the BonOlive and the active compound to the animals. And we could really see that these animals were completely protected against development of osteoporosis. So this was already a very fine, very nice proof that. In fact, does not only work in cell cultures, but it also works in animals. Now an animal is, of course, not yet a human being. So the next step was that we had to test this in humans. Now, as bone development and bone metabolism is a very slow process, we cannot just give you a product once and look at the results in humans. You have to keep giving the product for a long time.
So what we did was a 12 month study in which we gave 64 people either a placebo or our BonOlive product for a period of 12 months. So for a full year, people took either a placebo or our active compound, and we monitored how bone formation was stimulated in these individuals. Now, very interesting was that we saw a 32% increase in the most important marker of bone formation, which is osteocalcin, a generally accepted marker for bone formation. This marker increased with 32% as opposed to the placebo. At the same time, we could also see that individuals were protected against further bone loss, which we measured by actually looking at their bone structure and bone mineral density, by means of a dexa scan.
This means we have the data in vitro in animals, but also in a placebo-controlled double-blind clinical study, the golden standard of clinical studies. And the last study that we then actually performed, we knew it works in vitro, we knew it works in animals, and we saw that it worked in humans. The last step that we then had to investigate to complete the story was to see whether the active compound, hydroxytyrosol, the metabolite of Oleuropein, can also be found back in the body. Because if we can find it back in the body, and we see that there is an activity, we can really make a final link between our product and the protection against bone loss. And this we did in a bio-availability study in which we gave the product and actually found that there was a very good bio-availability and a very good circulation in the blood of the active compound.
Now, a very interesting finding that we also did in a clinical study and for which we also have mechanistic data, is that the product is not only active towards bone health, but also has a very positive effect on blood lipids and blood cholesterol. So, this means it also has a cardiovascular endpoint. Now, we had already expected that this would occur because, from our mechanistic studies, we found out that the bone forming cells are formed from what we call stem cells. Stem cells are the very early precursor cells present in our bones which then differentiate and transform into bone cells. Now, the same precursor cells, instead of transforming into bone cells, they can also transform into adipocytes, which are lipid-storing cells.
What you typically see in osteoporosis is that this balance between transformation of these precursor cells into bone-forming cells or into these adipocytes shifts more and more towards adipocytes. In fact, you get some kind of a fattening of your bone marrow as you get old. And this is in a large extent associated also with osteoporosis, because if your precursor goes towards fat-storing cells it doesn't go towards bone-forming cells.
What we found out was that BonOlive very specifically supports the transformation of those stem cells into the bone-forming cells, which means that you have less adipocytes, less lipid-storing cells, and you can actually also improve your lipid metabolism by taking BonOlive.
Interviewer: Can you talk about the safety of the product? And a lot of people might think, "If my bones are bad off I'd better take a little bit more." Is that safe to do if they end up doing that?
Sam Possemiers, PhD: Olives and olive leaves in general have a very long history of consumption. Everybody eats olives, has olive oil, et cetera. So, as such, there's already a very good safety. Now it's also important that there are other types of olive extracts which exist. And also, in this very specific olive leaf extract, never were any negative side effects found. This is just the history of safe use, as they call it. You can already see that there is no tendency of having negative problems.
Of course, if you want to develop our product for a very specific endpoint, we also have to be sure that our type of extract is safe. So BioActor has performed safety investigations, has performed it in animals, and has also performed it in humans, and no side effects were noticed. So, the product is perfectly safe for human consumption, even over longer periods as was shown in this 12 month clinical study.
Interviewer: You said that BonOlive is something that people should take for a longer period of time. When would they start noticing a difference? Obviously, they have to be tested. They wouldn't feel anything, right? But, when could they notice a difference in their bone strength?
Sam Possemiers, PhD: One of the difficulties, of course, with bone health is that it's indeed a very slow process. If you look at a product which lowers your blood pressure, you'll notice that immediately. Here, people will not feel immediately that they have very strong bones again. What we saw that, in fact, when we did this study and investigated the people after 3, 6, and 12 months- that already from 3 months on we could see this trend of bones was inversed, and that there was a gradual increase over time of this osteocalcin. So as early as 3 months, we could already see an effect, which is nice. Of course, if you want to really have long-term protection and prevention of osteoporosis, you should take the product as early as 30-40 years, because at that age the bone loss process already starts to become more important. Continue taking the product over very long periods.
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