Affron®: Positive Mood, Stress and Sleep by Pharmactive

Paul Clayton-Affron-Final Version

Danielle Lin,C.N.

Science of Your Life

Danielle:  Hello, and welcome. I’m Danielle Lin, and this is Science of Your Life, a library of podcasts and book created to educate formulators, developers, and innovators entering or expanding in the lifestyle industries. The interviews presented are conversations with leading companies offering premium branded ingredients backed by science, proven in efficacy and sustainability. There is a growing concern affecting millions of people of all ages. Perhaps the underlying problem might look like stress, but it’s showing up in human health as affective disorders, expressing itself as stress, depression, anxiety, and comes to the surface in many of the aspects that we will talk about deeper today like sleep disorders, and continuing a conversation that we started. I want you to understand that when we do these interviews, research is expanding so fast that almost by the time we are finished something new can come along. That is why this library is so important. So, today we will learn how a rising star in the botanical world has been shown to offer proven results for addressing these life-impacting issues. It’s safe and without side effects. The branded ingredient is Affron (or Affron depending on where you live) derived from a patented, standardized extract of the royal spice, saffron. It is distributed by PharmActive Biotech Products. Deep-rooted science is illustrious with its history and the cultural legacy of this refined and beautiful ingredient no doubt creates an undeniable combination which is impacting life worldwide. Joining us to share the clinical studies, applications, and therapeutic value of this particular standardized Saffron is Dr. Paul Clayton. He graduated summa cum laude in Medical Pharmacology from Edinburgh University. Prior to obtaining his Ph.D., he was the former chair of the Forum on Food and Health in the United Kingdom and senior advisor of the UK Government’s Committee on the Safety of Medicine. He is currently a Fellow of the Institute of Food, Brain, and Behavior at Oxford, and a visiting professor at the University of Pecs, Hungary. He is renowned for his international experience and advisory position for advising and advancing the standards of the nutraceutical industry. I’m very excited about this. Dr. Clayton, I’m so pleased that you could be with us today.

Dr. Paul Clayton:  Danielle, it is a pleasure to be on your show.

Danielle:  You and I were speaking before we got on the air about the fact that even from the last time that you and I were together in conversation, things have changed. So, it looks like this affective disorder that we are talking about, is it growing? What does the category look like and what do we really need to understand about this today?

Dr. Paul Clayton:  First of all, this is big. Depression (according to the World Health Organization’s statement last year) is the number one disorder globally. It has increased about 20% in the last 10 years, giving us about 350 million known cases, but you have to double that (at least) because a lot of people never get diagnosed. So, this is very, very common and is becoming increasingly more so. When you factor in stress and anxiety, they are almost universal.

Danielle:  Why, when you look at (we are talking about saffron), the history is so deep with this. People are familiar with it but why is it so important in this particular category?

Dr. Paul Clayton:  Because the pharmaceutical response to depression (and, indeed, stress and anxiety) has been so defective. They’ve given us drugs which are addictive, toxic, which cause problems with withdrawal symptoms, also implicated in many mass shootings in those people who can’t metabolize them properly, and they don’t even work really well. We urgently need more effective ways of treating these conditions. The best we have come up with, by far, by a long way, are the natural products, specifically saffron. It’s the number one horse in the race right now, and I suspect it will continue to be so.

Danielle:  What’s interesting to me about the whole category (and when you look at saffron) throughout this time together, really, what we are doing is talking to those of you that are formulating, that are looking to going into specific categories. Maybe, perhaps, you are looking down the road to say what is happening in society and, as a company, how can we address it better? When you look at something like affective disorder and you understand that if depression is growing and we know that it’s being addressed from a pharmacological point of view and the side effects and aspects of what happens from that can be changed by looking at it in a natural manner, with science, with clinical studies, that’s what we are going to cover today. We are talking about PharmActive Biotech Products. That is where Affron is distributed from, and we are talking with Dr. Paul Clayton, and we will return.

Dr. Paul Clayton is my guest, I’m Danielle Lin, and you are listening to Science of Your Life. We are talking about Affron, spelled AFFRON and, as I mentioned earlier, it is made from the standardized, patented saffron in a particular process and technology we will share. So, Dr. Clayton, I was asking you about saffron and why it was so important when we are starting to look at things like depression and the aspects of the brain functionality. Can you elaborate on that and what is the relationship there?

Dr. Paul Clayton:  We have an emerging new model of affective disorder and stress and anxiety, and they center around the concept of inflammation in the brain, specifically chronic inflammation in the hippocampus. What it does is it inhibits neural-plasticity. It down-regulates the release of neurotrophic factors, and we think this is really at the core of these affective disorders. We see more and more depression because we are living a lifestyle that is more and more inflammatory. Where saffron comes in, it works at a very low dosage and seems to have a very high affinity for that part of the brain, the hippocampus. It gets in there, switches off the inflammation, damps it down, and allows normal neural-function to start once again. Now the nerves are plastic again, they can form new connections, and we see an up-regulation of BDNF (that’s brain-derived neurotrophic factor). This is very, very important for neuronal health. I can’t stress enough; this is a much more profound mode of action than anything the pharmaceutical industry has come up with so far. It produces a very clean approach which is effective, very quickly effective after only 2-3 hours after taking the tablet, and it is entirely void of side-effects. This is a major breakthrough.

Danielle:  When you are referring to the mechanism of action, you mentioned something about the availability of a drug to target and have a specific impact. You kind of indicated that saffron does that naturally.

Dr. Paul Clayton:  Well, it does. Indeed, many natural substances do. You can go back 10 years to the work of Herman Adlercreutz at the University of Helsinki. He identified receptors for polyphenols dotted in and around the brain. The evidence that we have leads us to suggest that the polyphenols in Affron, very specific polyphenols target the hippocampus and they act on receptors there which generally have anti-inflammatory behavior but they are also regulating protein and lipid signaling pathways, and you are getting immune and neuromodulatory effects. So, this is a very specific effect occurring at a very tiny dose, 28mg. This is unprecedented in the natural pharmacological world.

Danielle:  With this saffron, when we talk about standardized and the process, it’s not like you are just going into your kitchen and taking some saffron and eating it. Can you address that?

Dr. Paul Clayton:  Of course. You could help yourself to the spice jar, but the problem is because of variations in climatic conditions, in harvesting conditions, storage conditions, you don’t know what you are eating. You may have a reasonable amount of the right molecules in there (which we know are polyphenols) or you might not. The whole thrust of natural medicine is EBN (evidence-based nutrition). EBN is where we start off by identifying the active molecules, and we standardize them so that every time you take a product (whether it’s tablet, a vial of liquid, or a bar of chocolate which contains the active ingredients), it doesn’t make any difference. You can be guaranteed of a standard, safe, and non-toxic effect.

Danielle:  Yes, this is very important when you are starting to formulate and put things together. That’s the difference in the step over the line wherein the pharmaceutical area it has to be standardized. It has to be duplicatable. In nutrition, we have, as an industry, grown into the point where you are talking about having the clinical studies, and as we continue through this, you will learn about clinical studies that are in conjunction with Affron. That is very different. A lot of companies will borrow science. That is what I was impressed with when I really learned about this. As we continue to discuss the clinical studies and specific benefits, I think you will see that in this branded ingredient there are certain highlight points. So, if you are developing products, if you are an innovator, formulator, and have your company looking to expand the brand category, the contact is PharmActive Biotech Products. You will find them at PharmActive.eu (it’s PHARMACTIVE.EU). As Dr. Clayton mentioned, they are expanding all over the world, and we look at stress factors and depression and what is occurring. It is said now that the stress and its relationship and correlations to declining health will grow higher in the coming years than heart disease and cancer. So, it’s a very important time to be talking about the benefits of standardized patents, saffron in this case. You are listening to Science of Your Life.

Joining me is Dr. Paul Clayton, talking about the branded ingredient Affron. As I mentioned, Affron is available (and I say that because if you are in a different country, you will hear it as “A”-ffron). It’s spelled AFFRON, and it is available from PharmActive Biotech Products. You can reach them, again, at pharmactive.eu. The important things, I think, about this particular ingredients that it helps to address everything from relaxation, mental and physical balance, maintaining a positive mood, it is the fact that it not only is classically imbedded in our awareness. If you mention the word saffron, it’s familiar. It has been around the world a very long time with an omnipresence in everything from ritual to food. When you think about that, we have a relationship to it already. So, it’s not a foreign substance. A lot of people,you would be surprised, consider when you start looking at the brain. This is so much more acceptable when people start feeling like, oh, I will put that in my brain, and I love that aspect. It’s just a flower. The simple saffron flower from parts of it. We’re going to talk a little bit more, but the thing I also wanted to mention is it’s important to realize that Affron is 100% vertically integrated through the company and throughout the whole process with 100% traceability from the crops, the raw material, to the final product. Very few companies can actually say that. This is important as you start to develop. It is also stable, 100% stable, due to the innovative extractions process. So, Dr. Clayton, we were talking about that stability factor with Affron, and you have been involved with everything from Pharmacopeia Nutraceuticals in the pharmacological part of the brain aspect. It’s really important when it comes to standardizing and being able to prove it. talk about that a little bit more.

Dr. Paul Clayton:  Well, let’s look at the clinical evidence that’s in the back of this. We have, I think, 19 perspectives, randomized clinical trials in Pub Med. Five of these (and more to come) have been conducted by PharmActive themselves. These range all the way through from mild, to moderate, to severe depression. Guess what? Saffron works in all of those conditions. Most recently, I was lucky to be involved in a study carried out in Australia on TGA regulations and we looked at the impact of Affron on people with low mood states. People with low mood states often are regarded as the precursor to depression. There is no pharmaceutical treatment for these at all, and the therapeutic index of the current drugs are such that you couldn’t use them in that respect anyway. We found that Affron works extremely well in this group already and is followed up by another study looking at mood disorders in children and adolescence. So, this has been shown, now, to work across the entire range of mood disorders all the way through from low-mood states, all the way through major depression in postmenopausal women, and middle-aged adults, young adults, and now in children. So, here we have an extraordinarily diverse and very coherent clinical evidence base. Coming in from preclinical, there is a whole raft of evidence there showing that the kind of stresses which create symptoms like depression in lab animals can be prevented and protected against using saffron. The brain chemistry has been worked out. In other words, we have gone all the way from ethnobotany, through mechanistic studies, through to clinical results and it is a very compelling and entirely consistent story. This makes up for a product dossier that easily matches and, in many ways, outperforms anything that the pharmaceutical industry has yet produced.

Danielle:  If someone was using a pharmaceutical, would it be appropriate to use the saffron (or the Affron)? Explain that to me.

Dr. Paul Clayton:  The answer, very shortly, is yes. We have a couple of studies, now, that show these things can be safely combined, Affron with the pharmaceuticals, but it gets better. If you add Affron (or saffron) to the pharmaceuticals, many of the side effects of the pharmaceuticals are diminished or disappear altogether. Now, what I tend to do with many of the people I advise who come to me and they are already thinking SSRI, I say, okay, don’t come off of that because we know there are potential issues. Start taking the Affron and in a couple of days, if you start to feel better, maybe you could start tapering off of the SSRI. Guess what? In 9 out of 10 cases they taper off. After a month or so they are entirely drug-free and are using Affron and doing very, very well. They are very happy about it because, frankly, nobody likes taking pharmaceutical products. The down-sides are so well known.

Danielle:  Right. We will talk about the up-sides of Affron and the use of it, especially as a developer in this market, it’s a growing market and an important concern. We are talking with Dr. Paul Clayton; I’m Danielle Lin. To learn more, you can contact them at PharmActive.eu or email to info@pharmactive.eu.

You are listening to Science of Your Life, and we are talking about PharmActive Biotech Products and, in this case, the active product is Affron (from saffron) for brain health and wellbeing. PharmActive Biotech Products is a research and development company focused on biotechnology of botanical extracts. I’ve been using this word “important” a lot this hour because we are seeing such a rise in depression and the effect it is having on this world. As you look at companies and you start to formulate, it is critically important that they have the backbone. In this case, this ingredient has GRAS approval, it’s non-GMO, trademarked, patented, and the company has the benefits behind them to offer you (as a partner) the substance with research and knowledge so when you are developing and need understanding of how to apply these ingredients, or to formulate them together, their research and development and innovative team is right there to improve the quality and efficacy of all of the botanical compounds, but particularly when they are working with you it is very critical. They are based in Madrid, Spain. Let me give you their email address and website. Their website is PharmActive.eu and email is info@pharmactive.eu. Dr. Clayton, in the short period of time we have we’ve talked about the dosage for Affron. You have mentioned, also, something to me before about the weight and the relevance of the brain. Will you address that slightly?

Dr. Paul Clayton:  Well, the effective dose (clinically effective) is 28 mg. There is only one other natural active which has given anything like a health claim in that dose, and that is the olive polyphenols. They work because they target LDL Cholesterol. The polyphenols in Affron work at this incredibly low dose because they are targeting a very small area of the brain. It doesn’t matter whether you are 300 kilos in weight or 50 kilos in weight, that part of the brain is the same size. These polyphenols are getting there, locking it, switching off the inflammatory sequence, and restoring neural plasticity. This is incredible targeting and, I think, the first of a whole new generation of natural products to come. Now, it sounds futuristic, but I want to jump back 1,000 years and go back to Abdullah Avicenna, the Persian polymath. He said, since all things have causes, the knowledge of anything is not complete unless it is known by its causes. Now, he is the Father of Modern Medicine, and he worked with saffron. His point is very relevant today. The antidepressants we use now are toxic, ineffective, have terrible withdrawal symptoms, and they are based on a hypothesis which I used to believe in, but I believe, now, is wrong. What saffron does (and what Affron does) is beginning to help us unravel the causes of depression and anxiety. We can now treat these conditions, as a result, more safely and more effectively.

Danielle:  I was looking at the Galvanic possibilities. When you see it in pills, capsules, etc., you can also combine Affron with herbal formulations, vitamins, and minerals. So, when you think about it, you can actually create proprietary formulations which makes it very valuable as a brand. You had mentioned looking at it from a food perspective.

Dr. Paul Clayton:  This is a food extract. It finds a home very comfortably in a number of potential functional food formats. So, we can talk about cookies. You can talk about chewing gum because it’s so versatile and only 28mg. You can talk about candy bars. You can talk about energy bars. You can put Affron in any of these which makes the consumption of the product non-medicinal. You do not have to swallow a quasi-pharmaceutical format which I think has all sorts of negative connotations. Now, you can make it part of your daily food regime. That, to me, makes it a very attractive proposition for a whole new group of potential users.

Danielle:  Saffron is expensive, so when you buy it, you get these little, tiny tins of it. How does that add up when you are creating a formulation?

Dr. Paul Clayton:  You know, the impact is less than you would think because, yes, it’s expensive on a per-kilo basis, but we are only using 28mg. With many natural products we are coming in at 100-400 mg for an effective dose so, yes, expensive per kilo but per dose, it is extremely reasonable.

Danielle:  I’m going to grab something that you had said to me before that this particular ingredient has been quite explosive in recognition of effects and the mechanism of action and mood and that you felt it was one of the more important when you really go throughout the clinicals. You were emphatic about that statement that it was a strong impact of the raw ingredient.

Dr. Paul Clayton:  Oh, absolutely. I think this is one of the hottest products in the natural product sector right now. You see, it gives us so many advantages over everything that has come before. With the antidepressants, they will take 4-6 weeks to work. During that time, people are vulnerable. The downside of those drugs is really considerable and very well-known. Here we have a product which, when you take that first tablet of Affron, within a couple of hours you feel your mood starting to rise. The shades of depression are starting to lift. People tell me it’s been like opening a window and letting the sunlight into a dark room. Its dramatic effects are rapid and onset. We have not seen any toxicity, any side effects or interactions, nor would we expect to. The pharmacology leads us to exactly the same conclusion.

Danielle:  We have been talking about Affron from PharmActive Biotech Products. Visit PharmActive.eu or to learn more you can email them at info@pharmactive.eu. Thanks, so much, Dr. Paul Clayton. I’m Danielle Lin. This is Science of Your Life.