Mark LeDoux, who is the founder, chairman and CEO of NAI, the industry-leading formulator and manufacturer of customized nutritional supplements, joined us to share his experience with beta-alanine, its current applications, and exciting prospects.
Tune in to hear about:
- The key health benefits when consuming beta-alanine
- The target market for beta-alanine supplements
- Differences between powder and tablet forms of beta-alanine
- The recommended dosage and frequency of beta-alanine intake
- Regulation challenges for beta-alanine within Europe
- The future growth of beta-alanine
Founder, chairman and CEO of NAI
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Vitafoods Insights 00:05
Welcome to the Vitafoods Insights Podcast. Join us as we explore the latest science and innovation, helping the global health and nutrition industry connect, develop, and progress. Today's host is Ajay Paul, graduate fellow.
Hello, and welcome to another Vitafoods Insights Podcast episode. Today we'll be talking about beta alanine. I'm delighted to be joined by Mark LeDoux, who is the founder, chairman and CEO of natural alternatives international or NAI, which is the industry leading formulator and manufacturer of customised nutritional supplements. Thanks for joining me today, Mark.
My pleasure. Thanks for the invitation, Ajay.
So I thought we could kick things off with a quick introduction to NAI. Could you briefly describe your motivation for founding this organisation and how this led you to become involved with beta alanine?
Well, I've always been astonished at the role between foods and pharmaceuticals and health status. And unfortunately, the unnecessary need for surgeries for people that don't really take good care of themselves. And so I was really focused as a young person going through college, back in the 70s, looking for ways to improve health done with a scientific method. And it's important to state that that, you know, there's a lot of old wives tales out there about, if you drink this concoction, it will generate a positive outcome somewhere. When I was going to college, I got a job as an operating room technician. One of my neighbours was a prominent ice surgeon and he said, listen, this is a great way for you to, to learn all about science in real application; you know, we have a need for somebody of your inquisitive nature, and stamina, frankly, to be able to operate with a multitude of surgeons in different disciplines in an inner city hospital setting. So, you know, here I am, filled with amazement that I'm being offered this job, paying about $1.35 an hour. And on the job training of sterile technique and developing an operating room suite, and proper draping, proper preparation of all the implements utilised in the surgical procedures. And then maintaining sterility and understanding what it means to break sterility, you know, gave me an enormous sense of appreciation for people that are in the healthcare profession. It was very interesting to see how many people though were suffering the ravages of all kinds of degenerative diseases. That to a large degree, even the surgeons would discuss, you know, had this person just done this? had this person just taken vitamin D, for example, there may have been less of a negative impact of whatever their lifestyle was. And I found it really interesting that even doctors were talking about this back in the early 70s. When I graduated from college, and I moved out to the West Coast of the United States, California, I met a fellow whose father had started a vitamin manufacturing company based in Long Beach, and I was offered a job with a subsidiary in Oceanside, California. And to my absolute dismay, when I got there, I saw that they were doing something with acidophilus products, that in point of fact, were being contaminated routinely, by virtue of the fact they had no sterile technique in the inoculation process. So they make 15,000 bottles of this wonderful material, ship it out to the health food stores and wherever their clients were, and three weeks later, 99% would come back with yeast, or mould, or something growing in the container. So that was my first application of scientific process by creating a manufacturing suite under something of sterile technique and inoculation of acidophilus into a substrate liquid, which then allowed the company to grow very, very dynamically and end up with a really good reputation. And then you fast forward three or four years and that company was sold, and I started out looking for natural alternatives to dangerous drugs that would have a benefit for human health. The more I studied some of the old pharmacopoeias, whether they be Europe, Asia or North America, even South America. The more I saw that there seemed to be a proclivity by pharmaceutical companies to look in the world of nature, identify something they thought they could synthesise at a later date, and then achieve a patent status once they'd proven the efficacy of their novel molecule. So, when you stop and think about things like Valium. You know, Valium actually was isolated as a chemical equivalent to one or more of the chemicals found in valerian root. Aspirin was created by a chemical synthesis, trying to mimic the salicylates that are found in the bark of the white willow tree. So, you start understanding that a lot of the pharmaceutical agents that have been deployed, over the last half a century or so, have their genesis in natural products, natural herbal substances, even things like antibiotics, which were miraculous, you know, came as a result of somebody investigating the fungus that was growing on a rotting orange, for lack of a better term. So that got me really engaged in looking for solutions for people that wouldn't cause the side effects that are so ubiquitous with pharmaceutical agents today. And while medicine has gotten much more proactive in helping people make better choices in their diets or behaviours, we still have a pretty substantial amount of disease in various parts of the world, that, I think are largely self-inflicted by virtue of poor dietary habits or poor lifestyle habits. So that was the genesis of starting my company, which was in my garage in 1982, or 1983. So we're now in our 40th year of kind of setting the gold standard, hopefully, for researching, developing, producing, and distributing products in 45 different countries around the world.
Thanks for that. That's a very interesting journey. And it's clear to see you have quite a passion for this area. It's also interesting to see the involvement that NAI has had within the supplement of beta alanine as well. Along those terms, I was wondering, what are some key health benefits and potential contradictions that formulators should be aware of in regards to the consumption of beta alanine? And this can be short term or long term?
Those are really good questions. First of all, beta alanine came to my attention as the result of one of my colleagues, Dr John Wise, introduced me to a colleague of his who was based in the United Kingdom, Dr Roger Harris. And Roger was visiting the states, and he had been working quite committedly to looking at creatine and, you know, in most parts of our industry, Roger is considered a pioneer in creatine evaluation, sort of the father of that molecule. And while that became an enormous component within the dietary supplement industry, particularly with sports athletics and performance, you know, he had come to us with some preliminary data that we found just fascinating, involving this unique product called beta alanine. And so, at that point, we decided to start funding some additional research while he pursued a patent applications appropriately. And what we discovered quite to our amazement, was that here's something in terms of a molecular benefit for humans, that once you loaded into your system, and I think it takes depending upon your body weight, you know, probably 30 days to adequately load a sufficient amount of beta alanine in your system to create a dye peptide known as carnosine. And carnosine is made up of a dye peptide, beta alanine and L-histidine. And what that molecule does, among other things, quite dramatically, is that as you exercise to almost to exhaustion, you create a by-product of exercise known as lactic acid. And the lactic acid, once it reaches a certain concentration in the muscle, basically just takes you to complete exhaustion. And so the muscle is not able to break down or contract any further, until that lactic acid is cleared. Well, if you have an adequate amount of beta alanine in your system, the resulting carnosine will help you exercise up to 15% longer before that muscle reaches the state of exhaustion. Well, you can imagine the impact that's had on people engaged in competitive athletics, particularly long-term endurance athletics. We've had lots and lots of Olympic athletes who have successfully utilised beta alanine and everything from their velodrome activities to their soccer matches, swimming, etc. So, it's received an enormous acceptance. And there have been, I think, over 50 human studies, many of which are really gold standard double blind, even crossover placebo controlled, demonstrating the benefits of ingestion and beta alanine, for improvement of exercise performance. But as we were looking at beta alanine, for outside the world of Olympians, and or athletics, we were struck with the reality that one of the biggest problems today, given the demographic changes that are taking place, is something called sarcopenia, which is a fancy word for a sort of a muscle wasting disease. And it's really not so much a disease as it is just a condition of ageing, that if you don't have the appropriate nutrients, and the appropriate exercise regimens, you know, your body is naturally going to be shedding some of your musculature capabilities. So, this is why a lot of people are concerned about the elderly becoming immobile, because, you know, they become frail. And this frailty is largely a result of sarcopenia, which has wasted away a considerable amount of musculature. And people get broken hips, because they fall and any number of things. So, we really focused our attention for several years, and we continue to do so on the positive attributes of giving carnosine in a sustained release format. And the reason we do that is we want to, not necessarily give you an immediate bolus effect of carnosine, which can cause a feeling of tingliness in your extremities, or on your face, or on your neck, not unlike what the transitory feeling is if you take a significant amount of niacin all at once. But that status is considered paraesthesia, and while researchers are clear that this is not injurious, you know, we don't think that that's something that the older demographic is really all that wild about. So, we designed and developed and patented mechanisms of delaying the action of uptake, are actually also delaying the impacts of, or are largely eliminating the potential of having that paraesthesia. So older demographics now are being targeted with sustained release versions of carnosine, or beta alanine, in order to create a buffering effect. But not only to help prevent sarcopenia, it's also been positively implicated in a host of other areas of concern, such as bone health, brain function, even cardiac function. So, the future is incredibly bright for this molecule, particularly in the elderly, as it relates to the sustained release version. And we're just scratching the iceberg here. I mean, I think we're very close to some technological breakthroughs as well, which will, hopefully achieve critical mass status at a regulatory level as well throughout the world. And we're really excited about this molecule, we think there's much, much more that we're going to see in terms of its benefits. And quite frankly, it's much cheaper to give supplemental beta alanine in the form of sustained release carnosine than it is to organise hip replacements, and/or knee replacements in the elderly, because they've succumbed to sarcopenia. So it's a lengthy answer there. And hopefully, it makes sense. But, I think, while the athletic market was an enormous success and continues to be that way, I think it's dwarfed by the demographics associated with a healthy ageing population.
In many circumstances, people associate taking beta alanine with pre workout and all the fitness trends. But as you just mentioned, there's a variety of benefits outside of that which target major different demographics which could have such a great impact across the world, and across different societies and healthy ageing. Going to be very interesting to see next 5, 10 years what that look like. You mentioned the difference between sustained release tablet versus maybe powders. Is there sort of different trends and preferences for those?
Well, I think to a large degree, the adoption of this a sustained release format, again, different marketplaces have different regulatory frameworks. So, in the case of Switzerland, for example, having a solid dosage form of 800 milligrams is perfect in terms of alignment with the regulatory requirements of that marketplace. Depending upon what the intended outcome is that you are seeking to achieve, if you're a gerontologist, or somebody that's just concerned about your own health, you know, if you go to www.srcarnosyn.com, you can see all the clinical studies that have been published there. And it discusses the dose dependency. So in many cases, we think 1.6 grammes should be sufficient for people that are concerned about healthy ageing. And that lends itself very conveniently to one tablet in the morning, and one in the evening. But for other attributes, if you're looking to reverse certain things, you know, 2.4 grammes has been identified as very beneficial, and so that would be tuned too. The powder format is also being evaluated for inclusion in ready to drink beverages, and whole meal replacement foods that are being designed by our regulatory and research folks. So, there's significant application here that extends beyond just the tablet. But for the current marketplace, the tablet seems to be the highest form of adaption, although I would expect within a year that powders will be co-equal, as they get rolled out in meal replacements, and/or other available forms. So, you know, the tablet has got great research, it's demonstrated its capabilities over many years, it's patent protected in most all countries in the world, as is the powder. And so, we're just excited to see where the next application will be. I think meal replacement will be a big component of that. And we're looking forward to the adoption of that raw material, as more and more major formulators in this whole marketplace, seek to expand their presence either directly to consumers or on store shelves. So, these are exciting times to be in this marketplace.
You mentioned as well, some regulations happening in Switzerland. I was wondering if there's any difficulties within the European market in general for regulations around this product? for example, maybe in the supply chain, which could potentially inhibit adoption of the supplements.
There's an old saying, there's nothing common about the common market. And now the United Kingdom has exited the EU, it'll be interesting to see what different countries do. But there is no commonality, per se, that I could say, is overseeing beta alanine in its current state. That said, I think there has been a wholesale adoption, based on the science that's been published, both here in the United States, as well as in Europe and other marketplaces overseas. I think it's really incumbent upon the commission to really sort out some of the things that are going on in the area of food law and dietary supplement oversight. You know, European Food Safety Authority has, has ultimate authority as it comes to health claims, through the health claims directive. And it's just interesting that they're level of scientific support seems to be on par, if not higher than many of the requirements to file an investigational new drug application. So, I think it just needs to get sorted out in Strasburg and Brussels, but many countries within the bloc have already accepted beta alanine. There, they see its great benefit. To date, I think, you know, countries like Norway and, and Denmark and you know, Switzerland, to the best of my knowledge, I think Germany and Italy have also adopted it. So, it'll be interesting to see how that percolates throughout the system.
I was wondering as well, along those lines, say given the next five to 10 years, how do you see the future growth of beta alanine looking like within this market?
I mean, it's directly attributable to demographic changes. If you think about the ageing demographics of Western Europe, you know, there's only two or three countries that are actually growing their populations, with their own citizens outside of importing new immigrants from various markets around the world. The same is true of places like Japan and Taiwan and even Mainland China. You know, in the areas that have the youngest demographics are places like Thailand and Malaysia, Indonesia, and to some degree Australia. But there are a lot of countries that are on an accelerated curve towards an ageing demographic. And I think that speaks very well for the opportunities that are presented by particularly the sustained release forms of beta alanine that, you know, are part of our carnosine state. And I think it's going to be self-evident within the next three to five years, that the revenues and the adoption are going to eclipse what's currently the status quo. So, we're very excited about that. And of course, our concerns are also on the quality of the material. Most all of our material we sourced from our colleagues in Japan, it's purely synthesised. There are other forms of this material that are coming in from other parts of the Orient. Unfortunately, we don't necessarily know how they're being made, there's been no application for a new dietary ingredient, which we think is requisite for those other players to submit to the Food and Drug Administration, much less to the European Food Safety Authority. So, we're actually concerned about some of the quality issues that seemed to pop up from time to time in this space. And we continue to have dialogue with regulators and their oversight to make sure that everybody understands that somebody takes something and gets ill because of it, that's probably too late in the regulatory process, that we should be a lot more diligent at the front end. So, we're hopeful. And we remain committed to protecting the consumer and protecting our customers from people trying to sell counterfeit products, which does no one any benefit.
Yeah, well, it sounds like it's a very interesting area at the moment, and there's gonna definitely be some changes that we will see in the next few years. And it'll be very exciting to see which direction it takes as well, especially with the ageing populations and the need for supplements like beta alanine to provide those benefits. Before we wrap things up. Do you have any final thoughts that you'd like to share with our listeners?
One of the things that's emerged from the global pandemic that we've all been experiencing, is that there is a renewed interest by consumers, across the economic spectrum and the geographic spectrum, to take another look at natural products, as kind of a first line of defence against this type of insult to our systems. You know, a virus, you never know where it's coming from, you never know how long it's going to be around, but this one has been of such significance, that people have really taken a hard look at what are the first lines of defence? What nutrients do I need to be using? What type of water filtration should I be using? What type of sanitary procedures do I need to embark on? And what type of healthy lifestyle do I need to adopt to make me less susceptible to coming down with an infection of ultimately potential demise? So what we have seen over the last couple of years, is a much more concerted effort to learn. And people learn by reading and reviewing, adopting and experiencing for themselves, the benefits of properly made supplements that have been subjected to proper quality controls, as well as proper scientific evaluation. So, I don't see any slowdown in the marketplace, I really am quite pleased to see more and more physicians adopting a more holistic approach to medical status management. And I'm very excited about the future of the industry at large, as long as we maintain the discipline of quality control, and not trying to test quality into something that's deficient after the fact. So, these are exciting times to be in this industry. We need to continue our dialogue with the researchers, the medical professionals and the regulators to make sure that people aren't abused, economically or otherwise. But by the same token that they have full and unfettered access to well-made dietary supplements and regimes, that will in fact, reduce the costs and the burden on the social safety nets of countries around the world. So again, exciting opportunity to share this vision with people all over the world. And we're very much committed to fostering this continued dialogue based on sound scientific principles, and quality research. And I think that's really, the future is bright if we stay focused on that approach.
Amazing. Thanks again, Mark, for coming on today and sharing all these great insights about beta alanine.
My pleasure, thank you for the opportunity once again, and I look forward to doing this again.
Vitafoods Insights 25:21
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