A proprietary form of citicoline, Cognizin® is a potent brain-health nutrient that’s been clinically tested to support attention and recall. Tested in human clinical trials and developed using a patented fermentation process, Cognizin is a pure, allergen-free GRAS ingredient that’s stable and effective. For a functional difference consumers are sure to notice, add the proven brain power of Cognizin to your next product.
More info at cognizin.com
Guest: Dr. Danielle Citrolo
Dr. Danielle Citrolo, Pharm.D. and Registered Pharmacist, is the Manager of Technical Services for Kyowa Hakko U.S.A., with responsibilities that include providing technical and scientific support to customers, maintaining Kyowa’s technical knowledge database, supporting regulatory affairs, and acting as liaison with regulatory authorities in the US, Canada and Latin America. Dr. Citrolo earned her BS in biochemistry and BA in chemistry from North Carolina State University, and her Doctor of Pharmacy degree from Albany College of Pharmacy in New York. She is licensed by the New York State Board of Pharmacy.
Science of Your Life
Recording Time: 0 Hours 22 Minutes 40 Seconds
DL: I couldn’t be more excited to talk to you. If you’ve never listened to any of these podcasts, I’m Danielle Lin, and this is called the Science of Your Life. It has been created to develop the most significant library of ingredients, literally the raw ingredients, the substance of your life, the things you need the most. As you go through this library you will learn, if you are a manufacturer listening to this, that the important raw ingredients today have branding, they have science, they have the clinicals to back up what they say and that is very important to me. That is why we have created this library. You probably (If you listened to the Setria Glutathione interview that we did) recognize Dr. Danielle Citrolo because she had joined us. She is a registered pharmacist, is the manager of Technical Services for Kyowa Hakko USA with responsibilities that include providing the technical and scientific support to customers, maintaining Kyowa Hakko technical knowledge, data base, and supporting regulatory affairs which is absolutely huge because she is acting as a liaison with regulatory authorities in the USA, Canada, and Latin America which has become so important in our industry. As manufacturers it is important, again, that you know who you are getting those raw materials from, what country they are coming from, what is the substantiation? Are they doing the testing to make sure they are clean? Dr. Citrolo earned her Bachelor of Science in biochemistry and Bachelor of Arts degree in chemistry from North Carolina State University, and her Doctor of Pharmacy degree from Oncology Pharmacy in New York. She is licensed by the New York State of Pharmacies. Dr. Citrolo, I’m so grateful you are back. I’m very happy because Kyowa Hakko USA, Inc. which is North American, it’s the sales office of Kyowa Hakko Bio Limited, when you look at what they have done in the area of not only U.S. health but international health in the ingredients area and has become the world leader (from my observation) in developing, manufacturing, and the development of fermentation technology, which I think is a significant difference for those of you thinking about putting products together. It’s very, very important for quality management and new product development. So, today I know you are back with us and we are going to talk about I think my favorite subject in the world which is brain health. In this case, Cognizin Choline, which I’ve known about for many years. I’ll tell you why later on. Let’s just talk first about cognition health. What internal and external factors effect the brain? Where are we at, again, we’ve talked about stressors even with Setria. When it comes to brain health these days, around every corner you are starting to see memory centers, Alzheimer’s assisted care. What is happening with us?
Dr. Danielle Citrolo: Cognitive health is a huge area that we are still learning a lot about. I think we are really naturally tackling some of the diseases that are happening in terms of cognitive health. I think a lot of the science and the medical fields are starting to shift more into preventing because they are really not doing a great job in treating. We really need to focus on preventing and that comes down to how do we keep our brain health? What are the factors? That has a lot to do with physical activity and an overall healthy lifestyle, a healthy diet, and also keeping the mind active. People that retire, once they stop using their brain it’s use it or lose it. You see a sharp decline. Other diseases really effect cognitive impairment. That’s why raw health is important. Cardiovascular Disease, Diabetes, things like that, they really do have a huge impact on cognitive impairment so really shifting to prevention and looking at lifestyle, diet, and how it can help with brain health.
DL: You just said something so interesting. It’s not just the memory issue, it’s also that you have a whole generation that is struggling with focus and also concentration. How does the Cognizin Choline work with that?
Dr. Danielle Citrolo: Absolutely, focus and attention is a big issue. I think a lot of it comes down to our lifestyle. We are so overwhelmed with all of our responsibilities in our lives between work, family, things like that and then with all of our technical things we are using with phones and stuff. Cognizin, one if its major benefits is helping to support with focus and attention. It does action in the area of the brain that is responsible for focus and attention and what it does is actually increase brain energy, too. It has been shown in clinical research the increase, ETp, in the brain. It is specifically active in the interior cerebral cortex which is the area in the brain which is responsible for focus and attention. We have studies that have demonstrated improvement in focus and attention and brain energy.
DL: In the next segment we are going to talk about the specifics of what Cognizin is and where the product comes from, how it can be effective in a formulation, and the mechanism of action. Lots of stuff to talk about. I’m Danielle Lin with Dr. Danielle Citrolo.
As we continue, we are talking about the brain. I have to say that I put together (years ago) one of the first brain formulas that hit the market place. It was developed by Dr. Powers-Kidd. I have to tell you that it changed my brain so radically that I have been a huge fan and know that you must feed and let me tell you something that was funny. Back then, many years ago, somebody said to me, “No, I don’t want to put anything in my brain.” But some would put it in their heart, their stomach, and everything else. So, it’s changed now, the perception that you do need to feed the brain. You must support the brain. It’s critical. Cognizin is the branded, raw ingredient that we are talking about. It is Citicoline and it is from Kyowa Hakko. Danielle Citrolo is with us, a registered pharmacist with a huge background working in regulatory affairs which is critical to our industry’s scientific support, especially as it comes to the technical part in customers. So, we have a nice rounded conversation. Dr. Citrolo, I want to jump right back in. So, Citicoline, jump into that a little bit more. If you were a manufacturer putting a product together right now, why would you put that into a formula and what would that do?
DL: What is Citicoline?
Dr. Danielle Citrolo: Citicoline actually does exist in our bodies. It’s part of the synthesis of oxidation of choline which is in our cell membrane. What this Citicoline does is really support the cell membranes of the neurons and the overall function and well-being of the brain. So, that is one of the most important roles. It’s really a protective factor as well. I talked a lot about focus and attention before but it also has a huge role in supporting the functional structure of the brain which is important. What makes Cognizin different and how does it stand out? There is a lot of the brain ingredients out there. I think it’s important to look at mechanisms, action, and kind of matching those up but all of our branded ingredients, we do amazing research. The research behind Cognizin in healthy subjects (which is what you need in order to make valid claims, especially in the brain industry today. That is an area that the regulatory bodies have admitted is their focus in terms of going after any false marketing claims). Kyowa Hakko does a great job with research and clinically backing choline in healthy subjects and it is a fermentation manufacturing process which makes it a pure product. It’s the only Citicoline on the market, Cognizin is manufactured by fermentation.
DL: What’s the unique difference in fermentation? Tell us what that means.
Dr. Danielle Citrolo: Fermentation is a living organism that produces this ingredient. What that means is you don’t have any bi-chemicals. You don’t have any impurities that can be harmful to humans. When you do chemical synthesis you have a lot of kind of extractions. Nothing that can actually contaminate the final product. Of course, chemical synthesis is getting better but fermentation is naturally one of the purest ways to get an ingredient. Our material is 100% pure. There are no additives, no anything. What you get is what you get. It’s a pure material with very little impurities, the lowest detectable.
DL: That is really important. There is so many. We are talking to both you, as a consumer and most critical as a manufacturer, the level of standard of integrity that has to operate at this time in history because we are talking raw materials in from all over the world. When they’re not documented companies will say they have this science but a lot of times the science is borrowed from companies. You look at Kyowa Hakko and the science gets borrowed and it’s not by permission. People will just jump on top of it and say that it’s Citicoline. So, it’s important that you know where the science comes from and very critical as to whether it’s a clean source and has been documented and clinically proven that it is effective. Then you start combining. You were mentioning and we were talking about the mechanism of action when it goes into the brain and it works in the body. What’s the outcome someone would expect of that as far as benefits?
Dr. Danielle Citrolo: The benefits that we see in the clinical research (and of course we will try to build on that clinical research…Kyowa has always got one or two studies going) of how the overall brain functions and that is one of the benefits. So, supporting the structure of our brain which helps preventing that decline and degradation that happens over time that leads to cognitive impairment but the performance type of outcomes, I talked about that a little bit earlier, would be brain energy. We have seen in studies that it increases brain energy by around 13-14%. That’s pretty good. We are also looking at focus and attention. That’s a major area that Cognizin really seems to hit home. We’ve had a few clinical studies in healthy subjects that really demonstrate it can improve that in healthy subjects, which is huge.
DL: Let’s take another break here. Coming up on the next segment is how will it affect you and what will you combine it with if you are a manufacturer and you want to look at a really substantial brain formula. This is really interesting. Dr. Danielle Citrolo, and I am Danielle Lin.
I’m Danielle Lin and we are continuing with Dr. Danielle Citrolo from Kyowa Hakko USA, Inc. The conversation we are talking about is your brain. If you are a formulator, as I mentioned earlier when I put a brain formula together it was the only thing I’ve ever done in a product. It was so effective in changing. I’ll give you my skills. I’ve read probably 4,000 books. When I started using supplements for my brain and for that expansion capacity for focus and concentration, I was able to absorb. I was reading probably 200 pages in general. Sometimes I am reading 600 pages a week. The sustainability of the information dramatically increased. So, there’s no question in my mind that if there was only one thing you’d have to do and you lived a long enough life, it is your brain that gets impacted by every other part of your body. We want to keep it fresh so you can be aware and have the energy mentally to take care of your life. So, Dr. Danielle Citrolo, Citicoline is obviously the raw material (if you just jumped in) and it’s Cognizin. It is delivered to support concentration and focus and recall, by the way. It is a patented formula of Citicoline and self-affirmed GRAS which is very important if you are a manufacturer. When we took our break here I had mentioned to you, let’s just say a manufacturer is listening in not familiar with the industry. They are brand new and have no idea, start with the Citicoline but if you were putting a formula together (as a manufacturer), talk to us about the value of a combination formula.
Dr. Danielle Citrolo: I think a combination with brain health makes a lot of sense. There’s a lot of good ingredients out there that are very healthy, that support the brain. I always think first feed yourself through diet and exercise. Getting it through foods is an amazing way. Look for antioxidants and things. When I look into a supplement there’s a lot of other great ingredients out there. Of course Omegas are well-known. We have Vitamin D, Vitamin B, Gingko and things like that with longstanding science to support that they are healthy. I think the most important thing when you are formulating with multi-ingredients for brain health is to really understand and look at the mechanism of action of the various brain-health ingredients. There’s a couple of ways to look at it. You can go for an angle of helping to support the brain by different mechanisms and then overall something that can pack the brain and really support the brain in different ways to increase the overall function and prevent cognitive impairment.
DL: What would that mean? Give me an example. So, like the Cognizin Citicoline would do this and let’s just say phosphatidylserine. Suppose you made a formula that had phosphatidylserine (which often times comes from lecithin, soy). Tell me what would be the difference when you say mechanism of action.
Dr. Danielle Citrolo: Yes, so both actually have similar mechanisms because what they are doing is helping to support the phospholipids which are the cell membranes, but they support different phospholipids. There you are increasing two different types of phospholipids that will only together help to increase the total structure of the cell membrane and function of our neurons.
DL: So, they don’t conflict, they actually enhance.
Dr. Danielle Citrolo: No, they don’t conflict. They actually enhance. Together you would expect, you haven’t researched and shown synergy specifically but what I’m saying is they work similarly in terms of looking at cell membrane and supporting cell membrane and structure and function of the brain and they support the specific phospholipids a little bit different. So, you are kind of overall increasing the total function and they can work synergistically for sure in that way. That’s what I mean.
DL: Yeah, I love that. Let’s take a quick break here and we’re going to come right back with some of the most significant reasons to in the marketplace right now develop (and Cognizin is the material we are talking about right now, that’s the branded part, and Citicoline is the actual ingredient from a fermentation process). We’re talking with Dr. Danielle Citrolo and it is Kyowa Hakko information on where you find them, how you locate them, how you would develop something and, if you did, what it would mean as far as a partner and the support that comes with it. I’m Danielle Lin.
So, I want to just give you some follow-up information. Kyowa Hakko is the company. Kyowa Hakko USA, Inc. The website, if you want to find out about Cognizin is cognizin.com. If you are putting a brain formula together or you want to do a single ingredient. Dr. Danielle Citrolo is with us, a registered pharmacist with an enormous background in technical services for Kyowa Hakko and certainly dealing with some important things. Dr. Citrolo, I’m going to jump right in about regulatory affairs, the things that the company if somebody is partnering with you, talk about that first as far as how important that is as you come to market these days, especially in the brain category.
Dr. Danielle Citrolo: Absolutely. You definitely, as a manufacturer, want to work with suppliers that are aware of the current regulations, especially in our industry. They are changing very rapidly recently and that’s a very hot area right now and a tough environment for the brain health industry as well. Working with a supplier that knows the regulations and follows the regulations is only going to help you and support you and prevent you from being under any scrutiny. Right now if you are looking for a cognitive product you need to consider that because the FDA and FTC have made it clear that cognitive health is an area that they will be focusing on in 2017. Working with a supplier that knows the regulations and abides by them is critical for the category.
DL: In the category, say I’m a manufacturer and want to put a product together, is it better to focus on say the baby-boomer demographic or am I going to focus on the student or can you take one formula which will serve the different demographics of who would need and want to have cognitive health products?
Dr. Danielle Citrolo: In terms of demographics I think it kind of makes sense to have two because the younger demographic is after a little different benefit. They are looking more for prevention, focus, and attention. In the older demographic it is definitely that they want more help. They are looking at memory recall. They want focus and attention, too, so there is some overlap but if you are marketing you want to look at what those different demographics want and then you want to work within your formulas to really market to them. They actually differ in what they need and want a little bit.
DL: If you took the Cognizin Citicoline and you started that as your base formula then what you’re saying is you would build around it with your other materials, your other raw ingredients, and that’s what you would distinguish. Is that what you are saying?
Dr. Danielle Citrolo: Absolutely. Yes, I do think Cognizin fits both demographics and then a multi-ingredient of cognizant health is most beneficial.
DL: Yes, you’ve mentioned Omegas, you mentioned B Vitamins, D Vitamins. There are so many things you can actually save from what I see from my own experience of creating a brain formula by one of the top brain researchers that you can put these things together. So, if a manufacturer comes to you and says, “I’d like to put that together.” Do you have that kind of support for them?
Dr. Danielle Citrolo: We can work with them a little bit with that, especially with the mechanisms. We’re not the experts in all of the other ingredients. We are the experts in Cognizin. We can let them know the clinical research that supports the benefits of Cognizin (which is focus and attention and brain energy). We are basically the leaders in continuing to support our customers by doing the research, the clinical support and claims that they want on the formulas that they put together. We’re not experts in the other ingredients but, of course, I can understand it and try to help them diversify their product if they wish.
DL: We talked about this before when we talked about the Setria, the idea of the support. When you go into the market it’s easy to make a product. That’s no big deal the truth be told if you can financially afford it. Getting it out there and having people find it, you’ve also done a lot of partnership in that with branding not only with the name but clinical studies and then consumer outreach where you actually educate the public for the manufacturers that do copartner with you. That’s a big deal.
Dr. Danielle Citrolo: Absolutely. We have a really, really great marketing team and they work really great with our customers and with consumers to do advertising in both the industry and the consumer marketing. They are really amazing. They can do anything from helping with websites too consumer brochures and things of that such, that’s one of the major benefits of working with Kyowa and just working with our brand of ingredients.
DL: I’ve never heard that before other than what you had mentioned so that’s pretty impressive. Especially as these companies enter. What can you put these in? Like, can you put Citicoline in beverages? Does it have to be in a supplement form? Can you go into new kinds of ways that people are marketing?
Dr. Danielle Citrolo: Actually, Citicoline is pretty amazing to work with. It is tasteless when dissolved in water. It’s only slightly acidic as a powder which is amazing as well. It’s stable at many different environments, in liquid, its heat and photo stable. It is very easily used with many formulas and it is compatible. It’s on the market with many other ingredients as well and has shown stability. So, it’s pretty easy to formulate with.
DL: And a lifetime supplement? Is it something that you just start taking and how much each day and when?
Dr. Danielle Citrolo: Yeah, absolutely. I see it more with healthy subjects and looking at prevention of cognitive impairment or increasing brain-health status. So, from the beginning of time, like people in their 20’s are already thinking prevention now. Also, they want attention with the focus and prevention.
DL: How many milligrams would you say?
Dr. Danielle Citrolo: Usually we do anywhere from 250mg to 500mg is what our studies show as benefits.
DL: Is it taken with food or without food?
Dr. Danielle Citrolo: It doesn’t matter. Any time of the day or night as well.
DL: Good. So, it’s versatile in supporting mental energy, promoting focus, supporting all cognitive health. If you want more information it’s cognizin.com, again Kyowa Hakko USA, Inc. A unique formula, for sure as an ingredient. Dr. Citrolo, thank you so much and we will look forward to having you back.
Dr. Danielle Citrolo: My pleasure.
DL: I’m Danielle Lin.
Learn more at: kyowa-usa.com
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About Kyowa Hakko
Kyowa Hakko USA, Inc. is the North America sales office for Kyowa Hakko Bio Co., Ltd., and distributor for Kyowa Pharma Chemical Co. As an international health ingredients manufacturer and a world leader in the development, manufacturing and marketing of nutraceuticals, pharmaceuticals and food products, Kyowa is a pioneer in the development and application of fermentation technology and maintains an ongoing commitment to research, developing innovative new products and quality management.