Welcome back to The Daily Mastermind, George Wright III, with your daily dose of inspiration, motivation, and education. And we're going to talk everything optimization today. I'm joined in studio with Shalin Shah, the metabolic CEO. How are you, Alan? Doing fantastic. Thanks for having me. Yeah, I'm so glad we could get together. And I'm going to give everybody a little bit of an introduction with you, but if you're listening to this episode, you know that we're about helping you to create the life you're meant to live and really focusing on mind, body, money, business, whatever it takes for lifestyle. But nothing says lifestyle more than optimizing your health, which affects every other layer. So Shalin Shah is in the house here. He's the metabolic CEO. He's a leader in metabolic and hormone health innovation. He's the CEO of Marius Pharmaceuticals. And we're going to talk about some cool stuff here today, but he's also the founder of the Testosterone Project, which is a national education and access initiative. And he's really reframed this idea of testosterone being a metabolic and longevity marker, you know, not just what many of you have heard. So, Shalin, I would love for you to jump right into it and kind of give us an overview of what brought you to this whole topic, why you're passionate about it, and what role does testosterone actually play for everybody right now? Give me kind of a little bit of a backdrop and let's jump into your passion for this topic. Yeah, no, absolutely. Thanks, George. So it actually started, my journey with this started about 10 years ago and it did start with a blood test. So I got my testosterone levels tested and again, lo and behold, like a lot of men out there today, it was low. And I really started digging into, you know, why this could be, it was, you know, frankly, I was around 30. I had my first kid, work stresses that are always present, right? No different today than it was 10 years ago. But really digging in to understand this because around that time, there was a lot of noise around testosterone and a potential cardiovascular risk. And the FDA changed the labels. They actually asked the industry to do a big study on this. And again, my research at the time because I was facing this indicated otherwise, that there actually was not cardiovascular risk associated with testosterone therapy and it could actually be cardioprotective. So my background is actually in the investment world and often taking contrarian views on different companies, right? Whether it's consumer, energy, industrial, et cetera. And that's sort of the sweet spot. So this kind of fell into that category and kept on digging. And everything that I read pointed in the other direction. And so what happened because of this FDA ruling per se, right, it created an opportunity with some of the assets that were in development. And there was an oral testosterone in development, which would be a game changer for an industry that is otherwise just injections and metagels, right? Yeah. So that's really when I jumped headfirst into this thing, took the drug through phase three development, and ultimately first shot FDA approval, which was a first for a testosterone asset. And that's really where sort of Kaiser Trucks was born then as we brought it into the market. But what's interesting for me is like, again, it's a product. Obviously, it solves a lot of problems, and we can talk about some of the interesting nuances on the safety and efficacy side, but it's the therapy at large that just kept drawing me to this because you've got a massive patient population, 25 million men here in the U.S. that are testosterone deficient. You probably have about 20 million females that are testosterone deficient, and this conversation is just becoming to—or just starting to get some light. Yeah, and I noticed that actually is becoming more than just this male enhancement impact performance type of a topic. And I do want to get into kind of your cutting edge work and what you're leading with this product that you took through development. But just so that we can lay a backdrop for everybody, because I think people really don't understand how much testosterone affects everything from your metabolism, your mindset, your energy and everything. And so a lot of our listeners are high performance individuals. so could you just give us a quick breakdown what how does what does testosterone play as far as a role in both your mental physical and longevity absolutely so let me put it in this context there's an androgen receptor or testosterone receptor on almost every organ in your body so there are thousands and thousands across your body whether it's on your brain your heart obviously your muscles bone and all the way down to a cellular level right mitochondria your mitochondria, the powerhouses of your cells are influenced by testosterone. And that's why when you're sort of symptomatic, you feel all these different things. It's not just a single symptom that manifests. And then also when you're optimized or at appropriate levels, you feel good, you know, sort of from head to toe, right? And it's not just sexual health and it's not just muscle building. It really is one of the most important metabolic hormones in your entire body. And that's what we're trying to get across to the general public, both honestly patients and providers. Doctors are learning about hormone therapy in real time. It's more and more research is coming out, right? I mean, it's not something that's had a lot. I know right now a lot of people, because you're probably seeing terms like TRT or testosterone replacement therapy and things like this. Shalyn, what would you say, you said this whole journey started with a blood test. What is a proper level And I know that we not looking to give any advice or anything here and everybody a little bit different But if somebody is starting to age and you been a big advocate of testing early not waiting until you are feeling sluggish and older what type of levels are typical, our standards should have? Because I've heard everything across the board from, you know, you don't want to be too high, don't be too low, you know, get your testosterone level to a level where you were when you were 21 years old, like what, give us a little bit of a frame of reference for this if somebody was to get some testing done? What's low and what's not low? So when most people get their labs and it's on their lab work, right, the reference range is generally 300 nanograms per deciliter to a thousand. That's considered the normal range, right? The problem with that range is that over the years, that lower end has gotten lower and lower. Some are even creeping to 250 or 268 right now. And that, again, is problematic because it's reflective of a relatively sick population. It is not what is ideal, optimal, best for a human body. It's just, again, a reflection of all of our labs collected together and a range. So a lot of the research actually points to the upper quartile being the most ideal. Like you mentioned, though, it is important you don't want too high levels, which we call super physiologic. At those levels, that's when you do start to see side effects. And I mean, frankly, that's the case for almost every molecular intervention, right? Like there's a sweet spot. You don't want to be too low. You don't want to be too high. Same with insulin in your body, right? Cholesterol in your body. All of these things have sort of sweet spot ranges because they do have roles to play. Well, and they're affected by a lot of other things too, I guess I had mentioned, right? So, you know, it's not as simple as just saying, take it to this level because other things will be off in your body, but keep going because I think you're absolutely right with the knowledge of you should be here, you should be there and what's normal. And when you age, you're just going to kind of taper off in your testosterone levels as part of aging. All of that is starting to go away and people are saying, look, I want to live optimized. I want to be optimized. Correct. I mean, just like, right, if you have eye failure, you're going to get corrective lenses or you're going to get cataract surgery. You don't just say, hey, I'm aging. Yes. Deal with it. Yeah. That doesn't make a lot of sense. So for testosterone, I think that personally, I look at that 600 to 900 nanograms per deciliter range as really being a sweet spot. But one thing that's important, as you mentioned, because as you age, your SHBG levels go up. Now, this is a binding, sex hormone binding globumin, and this binds to testosterone, making it unusable. So that higher level actually decreases what is your free testosterone, which is actually the testosterone that matters. So this is going to become more and more better known through the public domain in that sense, and people should be testing for it. But your free testosterone levels are what you really want to be targeting both from an understanding and then a treatment perspective. Yeah. So your testosterone levels, you know, if these other things are out of whack, that it's your free testosterone you want, right? So when you get into the right range, let's call it whatever range is that's optimized for you, what do you start to notice? I mean, your energy comes back, your mental clarity, you're talking about things tied more to cardio health as well. What are some of the things that are starting to come out that are making it more important for people to really identify this as a primary marker for them, testosterone? Yeah, so absolutely. So I mean, personally, for me, the biggest change was fatigue. You know, I was how I felt that afternoon sluggish really just, you know, I was overloading on the afternoon coffee, because I didn't know what else to do. But that was the biggest thing. I actually just I felt the 180 difference once I started therapy. But again, for everyone else, because there's androgen receptors all over the body, it does vary, right? If it is the brain fog or even like depressive symptoms, there's a lot of really good data that shows improvement across the depressive symptom score test once a patient is on testosterone. It could be that you have the inability to put on muscle mass, right? I mean, again, as we age, we know muscle is the organ of longevity. You can't, it's very difficult to put that on as you age and the fat metabolism also gets slower. So that might be for another individual, the differences that they see. But generally what we see is like a positive virtuous cycle, right? You have these improvements across your body. A lot of the symptoms can be resolved. And then again, how you choose to use this new fuel is up to you. Yeah. Well, especially if, look, if you're a high impact performance entrepreneur, founder, whatever it is that you are doing with your business and your life, your energy level, your mental clarity, your fatigue, it's going to impact every area of your life. And so if this is one of those key markers. I guess one of the questions that I have is, so people don't know a lot about it. The options that they have right now to increase their testosterone has typically been injections or gels, like you said, and then you went down this path of oral. So tell me about that, because I do feel like a lot of times with supplementation, when you hear oral, you think the efficacy and the ability for your body to absorb may be not as high. And I don't know, but give us a little bit of information about this research that you did. So we solved that problem. We cracked that code with oral. And again, historically, orals, people were concerned about liver toxicity. So what we created in Kysetrax is the ability, it's lymphatically absorbed. So it's absorbed through your small intestine. And that is really the breakthrough in the ability to now finally deliver testosterone through an oral capsule. The efficacy, you know, in our phase three trials, 96% of patients return to a normal range. Actually, the C max, which is your daily peak, gets to about a thousand nanograms per deciliter. One would say that certainly adequate That not a low number which again often is the perception when it comes to oral The beauty is though our bodies make testosterone on a daily basis right If you are a normal, healthy male, your testosterone production occurs overnight and peaks in the morning, gradually declines throughout the day. What we have with oral is the closest in mimicking that natural circadian rhythm. And that's really important because it changes the safety side, right? We don't need to achieve these super physiologic levels because we're not trying to sustain testosterone over a one-week period or a two-week period or even more. It's a daily rhythm that you're effectively trying to mimic. The product that you came up with, is it a daily oral or is it – like how often do you – because I know that there's spikes when it comes to TRT and stuff. So twice a day? Correct. Twice a day. And how do you manage the – with an injectable or something, you can measure the dosage and things like this. Is it pretty much standard dosage for all people or is it different depending on what you need? There's three doses. And again, your clinician, your provider can adjust based on your individual reaction. Most of our patients ended up on what's regarded as 300 milligrams BID or 400 milligrams BID in our trials. And we see that play out in the real world pretty strongly. Actually, most people end up on the 400 milligram BID dose. And there are good papers. We already have data, you know, real world data published on Kaisertrex showing what that safety profile looks like at that dose, which is quite fantastic. Wow. Yeah. So we've talked a little bit about what some of the symptoms may be and some of the benefits of that. I think a lot of times we don't talk about what the negative effects are of having low T and untreating your testosterone. What are some of the long-term consequences of not paying attention? Because I do think sometimes people think, well, you know, I'm just going to kind of avoid that, but they don't realize that there are some consequences you're going to face without it. And especially nowadays with everything and everything's faster paced, like you said, there's a lot more things happening to your health. Tell me a little bit about what your thoughts are on the long term. Yeah. So there's, again, there's a range of implications here as it relates to low testosterone. This is extremely well documented. The E, you know, the best one to cite off the beginning is that it was about 83,000 patients in a VA study. And it just looked at low testosterone leads to a higher all cause mortality, Full stop, right? So there was a direct line between higher all-cause mortality and low testosterone, right? So I think that kind of off the bat gets people to pay attention. But then again, you have to look at things like, especially as you talk about older folks, right? Look at bone mineral density and the role testosterone plays in there, right? So you have lower BMD in a testosterone-deficient patient. Again, you have higher depressive symptoms in a testosterone-deficient patient. Your metabolism, right? Your testosterone is an insulin sensitizer. So you're going to have implications there in your fasting insulin levels as it relates to testosterone. Your body is less efficient, right? Even your pancreatic, this is pretty technical, but like pancreatic beta cells, which are pretty important. And again, your overall function are directly influenced by testosterone. So it just cascades, again, throughout your body. And that's why it manifests in all of these signs and symptoms because it's not, again, obviously your libido could be totally shot. Again, you can't perform in the gym at all, right? Like these are the manifestations of the underlying cell biology misfiring. Yeah, yeah, it really is. You know, as you start to get more mainstream with optimization of your health, if you're listening to this episode, what you realize is that, you know, you don't have to deal with these consequences. There are solutions. And it seems like a real paradigm shift, Shalyn, when you talk about oral, because I do think it just is sort of a game changer. And I'll admit, I don't have a whole lot of experience with this. So I was really fascinated by some of the stuff that you have pioneered with Kaisotrex. But the oral, the whole idea of oral access for testosterone, that to me seems like a real paradigm shift. I mean, in a lot of different ways. Would you agree? Yeah, absolutely. Again, look, you have two good things that are happening with that. The first is, again, yes, the modality, right? So you have, you don't have to inject yourself, which again, which is not up everybody's alley. And gels, again, they have absorption issues. You have to, you potentially transfer it to your spouse or your children. That's a huge concern. There's actually a black box warning on those products for that transference risk. So you have these modalities that just really are not functional to, you know, again, especially an executive lifestyle, right? You're traveling, you're on the go, just a lot of things going that you cannot be dealing with these interventions. But the second, at that same time with the introduction of Kysetrex, you have the stigma is finally shifting on this thing. Like I mentioned, the FDA is relooking at testosterone and its indication, should it be broader than what it is today and basically similar to other disease states like, again, blood pressure, high blood pressure, high cholesterol. You treat those diseases full stop, right? And they're thinking about testosterone in the same way. And then the second is descheduling testosterone. Testosterone is a controlled substance today, which only adds and fuels that stigma of this thing being, you know, like a steroid for enhancement and performance when it's really just a foundational therapy, right? Yeah. And something your body creates. I mean it's not like, you know, obviously it's not something that's not already existing in your body. So. Absolutely. It's already known to your body. It knows exactly what to do with it. So that a really big one and that when as you mentioned the testosterone project on education and advocacy This is something that we fighting for because there so many barriers to care today as it relates to testosterone You know as I mentioned when I got my first test the first question the doctor asked was why And, you know, I had to tell him why. But again, that's why I think that FDA panel is really enlightening for anybody that wants to go back and watch it. It's actually on the FDA's YouTube channel. And they talk about the panel, you know, the experts talk about this is the single best biomarker of a man's overall health because it's even testosterone is anti-inflammatory. So it really, again, it tells us that it's the warning lights. These are the things that are going on in the body and to address it. And it's a $10 blood test. It should be done on our annual physical every year. Yeah. Even when you do blood work now, a lot of times it's just cholesterol and basic blood work and you have to request it. So it is important to, that's why I think it's what's fueling your passion for the testosterone project is because it's an awareness, right? But you also mentioned and alluded to it earlier, not just for men, but women. Help me to understand the difference in the critical need and also just the effects that happen for both men and women. So they're very similar in terms of the effects, right? Again, androgen receptors all over the body. Pre-menopause, women make four times the amount of testosterone in their body than estrogen. So it's not, you know, this misconception that testosterone is a male hormone, estrogen is a female hormone. No, men make estrogen too. and testosterone does convert into estrogen. So females absolutely need testosterone. It affects a lot of the same things that they do in men. They just have never had a therapy or intervention, right? Nobody's been able to sort of complete that. And that's something Marius is also working on. Outside of advocating it through the testosterone project myself, Marius does have a female development program so we can have an FDA approved option for females. Gotcha. Yeah, that's interesting. Well, let's say somebody doesn't really know a whole lot. they've probably heard things on the peripheral on testosterone and maybe they're even experiencing some symptoms. What practical steps would you suggest of where to get educated, what to do, what their options are? Where would you say someone goes first? What's your recommendations? So again, look, there's a lot of, well, there's good and bad information online, but there's a disease website. It's called rethinktestosterone.com. And that's a really good resource because it's all science-based. If you look on that website, there lists tons of papers and research that has been done over the last 10-20 years as it relates to testosterone. These are big studies as well, right? A whole range of studies on a whole range of sort of, again, how it affects the brain or the heart or mood, etc. I would start there. There's a lot of good information there and people can really help at least understand some of the basics. And then you really want to, again, look, it starts with testing. I think you want to find a good provider. If you have a good provider, I would ask them and try and have a conversation around it. But otherwise, I would find a good provider who really understands testosterone and hormones. Because if you're, again, in your 40s, 50s, 60s, it's likely that something that you do want to look into and understand, whether you ultimately need treatment or not. Yeah, it's definitely something that makes a big enough difference in your life that you should do that. Where's the best place for people to connect with you or even the testosterone project? What are some of the best places for them to connect with you? Yeah, so best, you know, on Instagram at the Metabolic CEO is a great place to start. Again, I try to be fairly active there. And again, it's like, this has really turned into a big education project. I could talk about it all day, every day. And I frankly do, right? So I think that's a good place. And then the testosteroneproject.com. So that will tell you about the advocacy efforts, the education efforts. There's a big section about females there as well. Because again, look, this is a couple's problem, right? A lot of our top doctors that we work with across the country, they seem like they're male specialists, but they actually treat male and females because they're both coming in and with the same complaints. Yeah. And you can't treat one and not the other. Yeah, exactly. Exactly. That upsets the scale even more. So we have a huge – and again, credit to a lot of our medical advisors who have really been so passionate and talked about this, not just recently in the last one, two years. right? They've been fighting for some of the changes in female hormone therapy for a decade, and they just happened, right? You know, a lot of credit goes to them, and I think they're going to continue to be champions for patients. I agree. I agree. Well, listen, man, I appreciate you joining me. I think this has been good, and I think more than anything else, the message out there is important. It's important for individuals to live a better quality of life and to not settle for maybe symptoms they have or even the different lifestyle they have right now that could be much better. So listen, if you're listening to this episode, share the show. Let individuals, you know, get this information as well. Our goal here is to help provide you what you need for information, not just inspiration and motivation, but education so that you can create your best life. And I believe it's never too late to start living your best life, no matter what your age is, no matter what you're doing, how active you are. So share the show. Let me know what you're up to. Hit me up on The Daily Mastermind on Facebook, Instagram, or YouTube. And we'll look forward to talking with you more. Shalin, thank you so much for joining me. Any last words you have? Any other tips that you want to give? Get tested. Find a provider and get tested. That's where you start. I love it. I love it. Okay, guys, have an amazing day. I'll talk with you more tomorrow.
