Season 6, Episode 8: Combating Sarcopenia with Peptides with Dr. Andy Franklyn-Miller

Evelyne: Me too. In this episode, we’ll dive into the science behind PeptiStrong, a groundbreaking peptide developed by Nuritas, and talk about its clinical applications and research. And this conversation builds on an earlier discussion that I had with Dr. Nora Khaldi, who’s the CEO of Nuritas. If you have patients who are concerned with muscle retention as they get older, patients who aren’t recovering as quickly as they’d like after exercise, maybe you have patients on GLP-1 medications and want to make sure they maintain lean muscle mass. We’ll take a deeper look into the data studies and what it means for health care practitioners like you.

To give our audience a little more context about your incredible background, Dr. Andy Franklyn-Miller is a highly accomplished physician with expertise in physiology, clinical design, and science communication. He has a PhD in Biomechanics and served in the Royal Navy and Royal Marines for 16 years. He has extensive experience working with high profile sports teams and elite performance and has published over 60 peer reviewed papers. He’s also an editor at the British Journal of Sports Medicine, and at Nuritas, he oversees multiple departments, including software engineering, data curation, data science, proteomics, lab, and regulatory departments.

So, I’m absolutely thrilled to have you here today Andy. Before we fully dive in, what’s lighting you up this week?

Dr. Andy Franklyn-Miller: You know, what’s really exciting is we have just had two clinical trial results on two new ingredients reported, and we’ve just got the data. And indeed, 580 pages is a summary of one set of data. So, you can kind of imagine where we are, but it’s tremendously exciting. We’ve got potential here in glucose control and cortisol management. So, two new ingredients are coming that way. And so, I’m deep in data analysis, it’s desperately exciting.

Evelyne: That sounds amazing and really fun. And you have quite an impressive background. And you came from this world. And I can clearly hear the excitement in your voice. So, what drew you to Nuritas?

Dr. Andy Franklyn-Miller: As a physician, we’re limited in the ability to see a number of patients. So, I might have seen 25 patients a day, looked after league teams. And your impact on the world is always limited by time. One of the amazing things about peptides is they have the potential to extend access to everybody over their potential health benefits. So, the excitement here is in building out an ingredient portfolio that can change the lives of billions and improve access.

And that’s what attracted me. It was the ability to increase health by design in millions and billions of people. And Nuritas has already had millions of doses of PeptiStrong around the world in different formats. And that’s what drives me.

Evelyne: That’s awesome. So, let’s take it a few steps back. What exactly are peptides?

Dr. Andy Franklyn-Miller: Absolutely. Look, peptides are everywhere. There is indeed a peptide solution for pretty much every problem we could come up with. They’re small signaling molecules. They happen to be a chain of amino acids, small proteins. Not tiny. So not the sort of molecular stage, but they have a function. And what they do is bind to a specific receptor and trigger a specific chain of events.

And we might know them from pharmaceutical peptides. And there are about 40pharmaceutical peptides that have been developed. The most famous probably now, moving on from insulin, is almost certainly the GLP-1 agonists, semaglutide, etc. but they’re, remember, heavily modified. They’ve been identified and then modified to extend function such as half-life or bioavailability.

And then others may know of peptides in the compounded pharmacy space where a lot of off licenses or out of patented peptides such as BPC or Ipamorelin, exist and they’re very much injectables. So, peptides have a signaling function like a pull down regulated pathway, and we’re using them to impact health.

Evelyne: Very interesting. And thank you for explaining that distinction. So, what are the benefits of peptides related to athletic performance? And then let’s get into PeptiStrong a little bit. What is PeptiStrong and what makes it unique?

Dr. Andy Franklyn-Miller: Absolutely right. So Nuritas is focused on identifying natural peptides. So that means they’re unmodified. And our source library is over 9 million peptides that we’ve identified from natural plant food growth sources. And one of the challenges people would ask is, are they bioavailable? How do they get in the body? And we’ll touch on that a little bit later. But that’s part of our AI development. In order to be able to predict those that will survive digestion and absorption. And we model for that, and we can talk a little bit about later.

So, what we’ve been able to do with PeptiStrong is shortcut millions of years of development. Because within PeptiStrong there are five clusters of peptides. So, it’s not just one, it’s not concentrated. And those five clusters work in very specific areas. One increased protein synthesis. So that’s where we assist in terms of building muscle and accelerating mTOR pathway.

The second area is on reducing muscle breakdown. People will often know about it as sarcopenia in a medical term or age-related muscle loss for the patient. And we look at two pathways there MuRF-1 and Atrogin-1. In terms of preventing that activation, that gene expression, in terms of that breakdown.

We’ve then three other areas peptides that work on anti-inflammation, peptides that work on ATP production, and peptides that work on bone mineralization. And so what you get with PeptiStrong is five different mechanisms of action, five different benefits in a 2.4 g dose, which gives both a compact but very broad functionality.

Evelyne: We’ll dive into some of the mechanisms of action further because I do have questions about the pathways and I do think that practitioners want to know, but I think they also want to know what are some of the things that you actually see in clinical practice and what is some of that clinical evidence.

So actually, before I ask about that, I have a few questions to set the stage a little bit more. So PeptiStong is derived from the fava bean, right? One question that I’ve received several times from practitioners is, is there an issue for those with G6PD deficiency?

Dr. Andy Franklyn-Miller: It’s a great question, and certainly one that, when we extract the ingredients, it does come from fava beans. So those with the bean allergy ought to avoid this as a supplement. In terms of Glucose-6 Phosphate Dehydrogenase, which is favism, the amount of fava bean in the end ingredient is very, very small and it’s under the limit of triggering of favism.

However, a patient who is considering taking it ought to have that discussion in terms of previous reactions they may or may not have, but it’s below the threshold. But certainly, we have it as a caution, as the ingredient because it comes from that source material in terms of fava.

Evelyne: Okay. And then another question that I’ve received is around the digestion part. So how do you make sure that the peptides actually perform their action and have their signaling effect and don’t get digested? And how do they not just break down to amino acids?

Dr. Andy Franklyn-Miller: Absolutely, Evelyne, it’s a really good question. And so, for example, there are over four and a half, 5 thousand peptides in PeptiStrong ingredients. And we know that well over 90% of those are digested in the gut as normal and broken down into amino acids. Like many peptides are. What we know from our own experimentation in the lab is, and it really goes back to how we identify an ingredient.

What we do when we start is we use our AI prediction tool magnifier, to look for peptides in certain areas. And with PeptiStrong we look for muscle health. So, we looked at peptides that would work on pathways in multiple areas. If we picked one and then performed a set of experiments on that one peptide, we might have been right or we might have been wrong, but we could have spent six months proving that point.

So what magnifier is able to do is take our 9 million peptides and condense them down to those that will filter for certain survival characteristics. And when we got down to the last hundred or so peptides that we wanted to examine, what we do with those is we synthesize the peptides, and we test them. So, we test the synthetic peptides first on a survival model and INFOGEST model, which is FDA approved in terms of which of those peptides will survive digestion. And then we preselect our raw material to contain the peptides that survive digestion, and then we retest the ingredient against those synthetic peptides, so we can be 100% sure that the peptides that are predicted to be in the ingredient and survive have gone through the INFOGEST-2 model and have therefore proven jejunum absorption.

So, the idea is we know a lot get digested, and of course they do. But the signaling peptides, the reason fava bean was the source material, is that gave us, after all, hydrolysis production, access to the peptides that will survive.

Evelyne: Very interesting because I’ve also gotten the question, can’t I just eat more fava beans?

Dr. Andy Franklyn-Miller: It’s a great question actually. Thankfully, others have done exactly that experiment. They’ve taken the fava bean, or even a hydrolysis of it and a non-precise hydrolosis and then look to see if those benefits of increases in strength, increases in recovery and energy or comfort. And they’re not. So, it’s the specific way that we manage that ingredient in its production to unlock those peptides in the areas that they are, which gives the activity.

Evelyne: Very interesting. Okay, so can you walk us through the three human clinical studies and the results of each one and maybe incorporate some of the mechanisms of action with each one that you saw?

Dr. Andy Franklyn-Miller: Of course. The first study was really focused on making sense of muscle mass. So, the idea was, would this ingredients retain muscle? And so again, looking at that mechanism of action, mTOR, that upregulation of protein synthesis and also the MuRF-1 and Atrogin-1 gene expression, the prevention of muscle breakdown.

So, in this first study 30 subjects, all male unfortunately. What we did was put them in plaster of Paris. So, we immobilized the leg from hip to ankle for a week. That was to induce muscle damage. And what we saw was that we got increases in creatine kinase. We got decreases in cross-sectional areas that, again, were consistent with inducing that muscle damage.

We took the cast off and then for two weeks they self-mobilized. So, there was no exercise component. So, they weren’t training. They were randomized blinded to either 20 g of PeptiStrong or 20 g of milk protein concentrate. And often, people question that 20-gram dose and you can see why it was a blinded trial. It was diet controlled. This was milk versus PeptiStrong. And it was important to have the two conditions similarly. What we saw at muscle biopsy was four times an increase in FSR. So that’s the protein synthesis rate in the PeptiStrong group compared to the milk protein group. So, this was four times protein synthesis of muscle in these subjects.

What we also saw was that two weeks after the self-mobilization part a significant increase in muscle strength. So, the subjects taking PeptiStrong regained over their baseline strength, whereas the subjects taking milk protein concentrate regained about 65% or so of their muscle strength. So, this was amplifying muscle force and it was increasing protein synthesis. We also saw in some of the myokines a decreasing creatine kinase and some of the other enzymes that break down. But predominantly what I take from this study is PeptiStrong amplifies the mTOR pathway and limits some of the breakdown of muscle, and some of the damage in associated with muscle.

Evelyne: Before we go further, I have some questions about the mTOR pathway. I think it’s received a lot of attention. People talk about it in the context of rapamycin. So, I know that mTOR is the central regulator of muscle protein synthesis. But can you just explain a little bit more what’s important about it?

Dr. Andy Franklyn-Miller: For sure. And look, there is some controversy around mTOR. You know, as you say, with rapamycin, and some of the longevity space, there is a question about whether you can do too much upregulation of mTOR and whether it can cause some fibrosis or indeed mitotic or cancerous change in cells.

What I’ll go back to is muscle is the low-hanging fruit for longevity. There are systematic reviews demonstrating 27% shift in all-cause mortality. So that’s including cardiovascular disease, metabolic disease, all cause cancers, neurodegenerative change. If you have everything else optimized in life in terms of that, you have muscle strength and muscle mass, lean body mass, decreased inflammation, then there is potentially room for wriggle in terms of the mTOR regulation. And there is also a difference between mTOR-1 and mTOR-2.

Some very recent studies on looking at the muscle loss associated with GLP-1 agonist treatment suggest that there’s also muscle loss via the mTOR-2 pathway, and the mTOR-2 pathway is cardiac muscle. mTOR-1 pathway, skeletal muscle. PeptiStrong was designed to only focus on mTOR-1, so there are no effects on cardiac muscle. There’s no amplification of mTOR-2. But obviously if cardiac muscle starts to deteriorate, there’s a chance of left ventricular hypertrophy, cardiac failure and all of the associated changes.

So to get back to mTOR, think about this is pushing a flywheel or pulling a flywheel. At the top of the muscle pathway, leucine and arginine, two amino acids are there to bind and upregulate the pathway. So, you need protein for mTOR to work PeptiStrong works at the bottom, at the ribosomal S6 pathway, so it pulls through the pathway. So, if you didn’t have protein at the top, you can’t pull through. You can upregulate mTOR by just using more leucine and arginine to a point.

Although some recent work suggests that as we age 50+, mTOR becomes quite sticky and the leucine upregulation has stopped, so we can’t just upregulate mTOR via that pathway by giving more leucine, which is a common misconception. And so there’s some good setting to work, and we’re producing some work in the lab looking at young and old, myosin cells with the Salk Institute, looking at that very detailed breakdown of that to come via nature metabolism. So, watch that space. But certainly, from an aging perspective, in those age cells, we don’t see that problem with PeptiStrong. PeptiStrong will continue to upregulate mTOR independent of leucine availability. A really strong reason for why that can support dietary change, can support longevity, can support that age, reduced muscle loss.

Evelyne: Very interesting. Thank you so much for sharing that. Let’s talk about the second study.

Dr. Andy Franklyn-Miller: Absolutely. I ran to the I ran before joining Nuritas. Here we had male subjects again, slightly older 30 to 45. These were trained subjects. The idea here was that we would induce muscle damage and compare what the PeptiStrong or placebo showed a difference. To induce muscle damage, we put them into a Cybex, isokinetic dynamometer, and we ran them through a leg extension, isometric hold, and flexion regime to exhaustion.

We then tested the strength through a multi rep program on the Cybex at 72 hours after that insult of injury. What we saw here is PeptiStrong, 2.4 g compared to placebo. We saw significant increases in strength recovery. So, the PeptiStrong group again returned 72 hours with stronger than baseline measures in strength. One of the really interesting differences though, was in a concept of muscular energy. We often get confused when we talk about muscular endurance. And then is that measuring VO2 max or is it measuring oxidative capacity? What does it really measure?

So muscular energy is, technically speaking, the difference in torque. So, if we think about extending our leg against the machine, every degree of change in that machine adds a layer of force. So, we might find it easy to start with and hard to finish or easy to finish and hard start with. So, an isokinetic dynamometer measures the torque through that whole angle. So, the amount of force we apply throughout the range. If we imagine the first rep for the last rep, if you’ve got a lot of muscular energy, you can match that. You can match your performance from start to finish. If you’re getting out of a car, to climb a flight of stairs, or to play a round of golf, or to go shopping, or to go out and play a round a tennis or play with the grandkids. It’s the same thing. It’s your ability to do the same thing over and over again. Do you want to go and do another class in the gym? Do you want to go out and get the energy to go and do what you want to do? It’s the same concept. What we saw with PeptiStrong was a significant impact in that muscular energy. Almost 130% difference between the two groups in terms of muscular energy.

We also saw a range of myokines. So, we saw suppression of myostatin again as an effect of that action MuRF-1 pathway of reducing muscle breakdown and then also a dampening of some of the inflammatory responses. So, in the second study, increases in strength increases in muscular energy.

Evelyne: So, I have to follow up questions for you. So, in this study you used the 2.4 g dose. Why did you decide to use that one at that point versus what you had used in the previous one?

Dr. Andy Franklyn-Miller: Absolutely. So, when we design the experimentation in and around the peptides, we have an AI model which will generate our optimum dose. And remember, this ingredient has a number of applications in the mineral supplement space, in the space that your practitioners are using it, but also in food. And so, this work, this is not a pharmacological product. So, this doesn’t have the typical dose relationship. The dose curves as part of its production. So, we use an AI generated optimized dose which is 2.4g. The previous study, it was very much a study designed to act as a placebo control. So, it had to match the amount of milk protein. So, 2.4 g is the AI generated optimum dose.

Evelyne: Okay. And then I also have a question about the MuRF-1 pathway. Can you explain that more in the context of everything that we’re talking about like muscle breakdown muscle energy?

Dr. Andy Franklyn-Miller: Yeah, absolutely. So again, this concept of sarcopenia, why does muscle, why do we lose muscle in terms of age related change? To MuRF-1, Atrogin-1, our fox mediated gene expression markers. And what they do is reduce the turnover of muscle. So, we want to inhibit that pathway. We want to we don’t want muscle breakdown to occur in terms of muscle loss. There are obviously multiple factors there. So sufficient protein, sufficient muscle stimulus and all of these things take part in that training. But one of the significant factors we’ve already talked about in terms of this dampening of the leucine drive of the mTOR pathway, so in combination, retaining muscle and maintaining that muscle balance pathway really is an anti-sarcopenia measure. So, it’s preventing the expression of these genes.

Evelyne: Okay. And then I don’t know if you mentioned it or I just have it in my notes. But the Atrogin-1 pathway? Can you explain that one as well and how it ties in?

Dr. Andy Franklyn-Miller: It’s the same too. They’re fox mediated gene expression; it’s just the two different alleles are the same pathway.

Evelyne: Gotcha. Okay. And then what about the third trial that was done on PeptiStrong?

Dr. Andy Franklyn-Miller: Absolutely. So, the third trial, we’ve actually just responded today to the review comments from the British Medical Journal of Nutrition submission. Here we looked at men and women. This was an exercise trial. So, we had two months of exercise programming three times a week in the gym. And we compared again, placebo, to PeptiStrong. With this trial, we took novices. So, they hadn’t been in the gym before. And so we expected them, both groups, to increase in strength. And our outcome measures primarily were strength. And again, this muscular energy concept, we use diaries to measure their protein intake. And the protein intake between both groups was matched. There was no statistical difference between the two groups.

What we saw was a 17% increase in strength in the PeptiStrong group compared to the placebo group. So, the placebo group was stronger, but the strong group was 17% stronger at the end of the study than the placebo group. And when we looked at muscular energy, the number of reps fatigue or the number of reps completed, we had almost a doubling again, statistically significant doubling of number of reps in the PeptiStrong group to the placebo.

And what’s not in the paper is because the study was designed as men and women combined, we didn’t power the study to look for statistical differences between men only or women only. But what we did see, interestingly, is that the men gained strength quicker. So, the men gained most of their strength in the first month. The women gained strength very evenly across the two months. And that’s useful advice for practitioners using the product, in terms of watching that curve. So, men gain strength quicker than the women.

Evelyne: That’s really interesting. Are you doing additional trials looking at just women or kind of teasing this out further?

Dr. Andy Franklyn-Miller: Yeah, absolutely. So, where we are now is that we’ve many research partners taking the ingredients and beginning to do additional research, both with PeptiStrong, with PeptiStrong with other ingredients in combination.

There’s a current trial looking at an age population, underway, in Hungary. And there’s a trial in the UK underway in terms of again, teasing out differences between men and women and their responses. So, more to come. Not yet on the radar.

Evelyne: Great. And then I also want to talk about two other mechanisms. The reducing inflammation and the effect on TNF-alpha, and then also on ATP peak production. Can you address both of those?

Dr. Andy Franklyn-Miller: Well, let’s talk about ATP. So, one of the areas we’ve been looking at is how PeptiStrong compares to other ingredients. And we’ve been doing that obviously in cells because it’s an awful lot easier to do. And again, this is pre-submission work. So, I can talk a little bit about it, but I can’t talk necessarily too much in depth. But what we saw with PeptiStrong was, when we looked at it, compared to creatine, PeptiStrong at 2.4 g compared to the 5g doses we typically see with creatine, matches ATP production in cells. Now that’s exciting because that’s creatine’s main focus.

What we also saw was some synergy effects. So, there was an amplification of creatine’s effect when you put PeptiStrong on, but in a different way. So, some of the ATP production obviously is divided between oxidative phosphorylation and glycolysis in terms of the two mechanisms. And we see an ox force increase with PeptiStrong that we don’t see with creatine.

That’s exciting because the two work by slightly different pathways. And therefore, we can get an amplification effect which we’ve also seen in those trials. So, creatine and PeptiStrong go very well together as a combination. Because when we look at the phosphorus six response, the increase in protein synthesis, creatine doesn’t really do that. And we wouldn’t expect it to. But PeptiStrong beats it five times. Because that’s one of the additional benefits. We have pathways and peptides working in different pathways.

And then you touched on inflammation and PeptiStrong was designed to work by TNF alpha to suppress some of the longer-standing inflammation associated with muscle. Inflammation is a complex area. And we know now that low grade inflammation generally in the body is responsible for an awful lot of long-standing and noncommunicable disease type prevention.

We know that inflammation can lead to metabolic syndrome. We can know that inflammation can lead to cardiovascular disease. So, inflammation prevention is something Nuritas is very passionate about in terms of peptides very specifically. What we want in terms of an acute response to muscle injury however is we want a norm. We want a spike in information.

So, we want IL-6 to increase, but then we want to suppress it because it takes away some of the muscle soreness and some of the anti-factors in muscle synthesis. And that’s what we found when we looked at the myokines in both the second and the third studies. With PeptiStrong we see there’s a transient increase in inflammatory markers and suppression of the secondary response. So, within 1 to 2 days after the insult of exercise we see suppression, which is what we really want in terms of. And when we saw, when we used patient reported outcome measures, we did with the third trial, we saw significant increases in perceived feeling of wellness, reduced soreness, feelings of energy. And that correlates well with those decreases in inflammation.

Evelyne: That’s really interesting. Since you brought up creatine, I want to go back to that because we know that creatine has additional benefits. But the synergistic effect with PeptiStrong is really cool. What about some other ingredients like myHMB or you touched on leucine earlier. Do you see a synergistic effect for those as well? Like how does a practitioner prioritize what to recommend?

Dr. Andy Franklyn-Miller: Absolutely right. And so, with HMB again when we do a comparison, HMB works via mTOR. And you remember HMB is a subsidiary of leucine. So, we’ve got, it’s a breakdown product potentially. So, it works by the same pathway. We see that at half the dose PeptiStrong is 60% better. So, it works better than HMB at a smaller dose. But then also, there is a synergistic effect. When you combine the two together, it’s 130% of the effect. So again, HMB and PeptiStrong work well together or can allow you to reduce the dose of some of the other ingredients.

And it’s similar with leucine. What we see with leucine is PeptiStrong is four times superior to leucine at up regulating mTOR at a hundredth of the dose. So, you have an intensity of effect with peptides that you don’t get with substrate. And leucine obviously being, as I was saying, it’s a push at the top of mTOR. So, the precision peptides allow you to get upregulation of activity with less amount. So, you can narrow the portfolio if you like, in terms of prescription. Or you can use the synergistic benefits with whey, with HMB, with leucine, with creatine to get an amplification of the effect.

Evelyne: Though, HMB does more than just protein synthesis, right?

Dr. Andy Franklyn-Miller: Yeah, for sure. Absolutely. And that’s where the complementary nature here really comes in. PeptiStrong has these very five specific areas HMB has its own, along with creatine, we know that creatine has some neurocognitive function that we’ve recently seen in publication. And even a cardiac prevention work published just today. But we also see with HMB there are other benefits, in terms of bone, in terms of energy, that certainly again align with that complementary prescription.

Evelyne: Great. So, from a clinical perspective, how do you see these impacting patient outcomes? Obviously, you’ve done the clinical trials right. But you’re working with patients. You’re hearing testimonials. Are there particular patient populations or conditions where PeptiStrong shows the most promise? Because I think most of the testimonials that I’ve received and that I’ve been sharing are in athletes. Though there are, you know, some other ones where it helps with fatigue.

But I think that I’ve even, you know, encouraged more of my practitioners who I know workout regularly to try it out. So, I’m curious, like aside from like sarcopenia, where can it be the most beneficial?

Dr. Andy Franklyn-Miller: What I’ve seen so far and where I’d used it, it’s very much in the active aging, as an energy muscle support structure. So certainly, in the group that are still active, but perhaps not gym goers and maintaining or struggling to maintain the same level of energy that they would have had previously. I think it works incredibly well in that sort of group. So that’s that sort of 45 onwards, through the 70s, who aren’t necessarily in a care home or in aged care facilities or very immobile, but certainly those that are struggling to get up and go, and that’s an area I think really that’s very strong.

In the athletic support, we’re seeing increasing use by professional teams. And certainly, in that area in terms of enhanced recovery and in terms of enhanced performance. It’s resonating very well in that population, particularly in that group with rapid muscle growth and maintaining the ability to keep on that sort of almost overload pathway.

And then that third group, certainly in terms of where we’ve seen some significant benefits, is where there is some expected muscle loss. So obviously with that significant number of prescriptions of GLP-1 agonists, in terms of managed weight loss, PeptiStrong is filling the void in trying to maintain muscle mass in those areas. And certainly, we see some interest in some longer term studies about to start in the UK, looking at those coexisting prescriptions in order to try to maintain that lean muscle mass, which is so critical in terms of general health.

Evelyne: I was going to ask you about those on GLP-1 medications because they are so common now. So that’s really great. And Andy, you said something there about the 45-year-olds. I hope that they’re not in the long-term care facilities yet. So, you made me think of something else. I asked you earlier about doing trials more specifically in women. And I’m curious because I’m sure you’ve seen there’s a big movement right now about women in perimenopause and post menopause and the maintenance of muscle mass, like people are really realizing how critical this is. Do you have any studies planned to differentiate some of the results between maybe women of reproductive age, perimenopausal and postmenopausal?

Dr. Andy Franklyn-Miller: We’re actually collaborating on a study in the Netherlands, which is due to kick off, just in Q2 of this year, which is looking at actually the individual prescription of food or meals and looking at the individual response. It’s part of a much wider study and our impact there is to look at PeptiStrong, in terms of the preservation of muscle and preservation of energy in very specific subsets of the population, of which that that is one.

And I think you’re absolutely right. There are very few studies focused in and around perimenopausal women. And the maintenance of muscle mass is so important. That is certainly an area we’re looking at in terms of dedicated studies, by Nuritas in the future, because both in terms of feature ingredients, where we’re looking at some very specific products, but also, just in terms of balancing the amount of research that’s out there.

And, you know, even the periodization of dosage of supplements is different in women. And certainly, although we were delighted to see the benefits in men and women in our last clinical trial, certainly what I describing in that sort of step-by-step approach suggests that actually the response may be a little slower in women in some categories. And certainly, we need to investigate that further.

Evelyne: I’m really glad you shared that because that’s really helpful to know. And I think in men too, because a lot of times I think we do these studies in young college aged kids like 18- to 22-year-olds, and maybe they’re the ones who would volunteer to have their legs in a cast for seven days. But I think so much of the research in general is done on college aged kids, right? Because they’re, you know, kids, they’re adults at that point. But you know what I mean. So, I’m curious about studying in older men as well.

Dr. Andy Franklyn-Miller: Many of your practitioners are well aware of the challenges of publication, and that’s one of the challenges here is we’d love to do more real-world studies. And actually, you’ll see from Nuritas, all of our studies moving forward will have some form of wearable technology embedded within the study so that you can use with your patients. Well, look, in this study we saw these sorts of changes, because I think the client, that the patient is getting more and more informed about wanting to see actual hard evidence of the benefit of what they’re being prescribed.

Alongside that, the presenting of individual results rather than in group means is really valuable. One of the challenges, though, is the major journals don’t love that sort of publication. And yet we all deal with individuals every day. So actually, what matters to us is, is how the individual in front of us changes and we’re giving personalized care to that individual.

And so, there is a pivot shift in research. You will see from Nuritas much more real-world studies in terms of much broader range ranges are much less restrictive in terms of inclusion criteria. Because you’re right, if you get too strict on inclusion criteria, it’s not the real world. If we look at a 50-year-old who has got no underlying disease states and no concurrent prescriptions, that’s pretty rare.

So, you know there is a Lancet publication suggesting only 1 in 15 patients is technically healthy with no concurrent illnesses. And so, we’re already, if we only focus on those people to do our research, we don’t give a representative sample. So, what you’ll see from us is more and more broader range ranges, wider inclusion criteria for an individual result. Publications using wearables is the way to do that as well, of course, as our primary outcome measures.

Evelyne: No, that’s really cool. I always think it’s so hard with clinical research, especially for those of us in integrative functional and natural medicine, etc., is we’re not just recommending one thing at a time, right? Like we’re recommending diet changes, we’re looking at genetics, we’re looking at what’s going on in the gut microbiome. And so, you’re not ever in the real world looking at one thing in isolation. And even within studies on nutrition, it’s very hard unless you feed everybody the exact same thing to even control for that. Right? I think that’s one of the biggest issues with a nutritional epidemiology is the surveys that it’s based on. Like, I couldn’t tell you everything that I ate yesterday, or I’d probably not report it completely accurately.

Dr. Andy Franklyn-Miller: Right, absolutely. And then so you’re left with that with a very non-real-world study where you bring people into a laboratory for four weeks and feed them only what they’re allowed. And that’s the way we’re working on in the Netherlands in that sort of almost lab-controlled environment. You get a great physiological answer, but it’s not very practical.

And you’re absolutely right. You know, patients are patients, and they’ve got lives and they do things and they don’t do the same things every day. My time as team doctor for Olympic rowing, it was very different. You know, our patients are athletes. We had data on blood lactate and blood ureas 4 or 5 times a session. For every session for every day of every Olympic cycle. And some athletes were on their fourth Olympic cycle. So, you could compare training session 260 with training session 260 for every year for 12. And so that’s that, that’s the benefits. But it’s not real world.

Evelyne: That’s fascinating. So, for practitioners who are interested in implementing PeptiStrong we’ve given some little tidbits. But what do they need to know? Like, are there specific clinical guidelines around timing? For example, do you take it around workouts? Do you skip days? Can you talk more about that?

Dr. Andy Franklyn-Miller: So in a lot of the studies, we advise taking it in the morning, normally an hour before a meal. There was no real, evidence for why that that case is. Certainly, what we know in terms of peptides, if you take it with a meal, it’s likely to be challenged by the gut acidity, and it may take a little longer in terms of being absorbed. But the effect of these peptides is relatively short. They’re plant-based peptides. We know they’re half-lives; they’ll upregulate the signal and they’ll be gone. This is not a long-lasting effect. You don’t need it. It’s an upregulation of a signal.

So, the timing matters, much less taking on an empty stomach, obviously better in terms of, of absorption. And then it’s a bit more controlled and then 2.4g in terms of the dose. In the elderly, or the over 50s, we know that leucine dampening. And so, there’s that little evidence to suggest that unrestricted protein at that level will give any amplification. But PeptiStrong will.

Evelyne: Okay. Very good. And what about your personal experience taking it? What have you noticed?

Dr. Andy Franklyn-Miller: I think one of the most marked things is when I was designing the study, I’ll hold my hand up. I was designing it to fail. I was a little bit skeptical. And what blew me away was this force amplification. So, this increase in strength and energy. And I would say my take home from PeptiStrong is this feeling of energy, the ability to keep going, to do what you were doing beforehand, and push out more reps in the gym is probably the most obvious take home. But the feeling of energy is this base level, which I think really is transformational.

As for bone density, though, our last study we saw an increase of .7% difference in an increase in bone mineralization. I’ve not done an annual Dexi yet, but I’ll be interested to see, what my bone density is like because we’ve been particularly favorable compared to vitamin D in calcium supplementation. So again, an area where peptide activity is superior.

Evelyne: That’s really cool. And one of my colleagues, he had an amazing change in bone or an increase in bone mineral density, I think it was in 6 or 7 weeks and also a decrease in fat mass.

Dr. Andy Franklyn-Miller: We had a similar effect of vitamin D and calcium over year in two months of supplementation. So again a very specific pathway in your brain. It’s a go-to in that area.

Evelyne: I’ve heard some other amazing testimonials, and I shared one from our CEO when I interviewed Dr. Nora, which was incredible. Probably one of the best I’d heard because he was training for an ultramarathon at the time. And then a friend of mine, he saw me post about it. I didn’t give it to him. He bought it himself and then, I didn’t hear from him for a little bit. But about a month later he had been training for a marathon, and he sent me a screenshot of his VO2 max and it was 60. And it was like, what? What was it before? And he said it was in the high 40s, low 50s. So that’s in one month. It really jumped up. And he said he felt like for the first time, he was always running tired prior. And he said that after taking the PeptiStrong for a month, he felt like he could go for a run at any time of the day, which was really cool. And he also ran as fast as smile ever. Now that was also partially training. But this is somebody who was a college athlete and now in his early 40s. So that was a really cool story that I got from someone.

Dr. Andy Franklyn-Miller: Absolutely. And we have a global elite team currently looking at our output with PeptiStrong and another one of our ingredients, which is not yet released, looking at a combination of glucose maintenance and power output. So, there are some really exciting performance studies on the way, that I can’t yet share with you, but the early results are really exciting. And I think a lot of that is ATP, in terms of this force amplification and that feeling of power. It’s transformational.

If this was five different ingredients put together, it would either be too expensive or it would be it would be synthetic. And I think the fact that this comes from nature that we’ve got significant amounts of science here to identify very specific peptides that have been through all of our preclinical batteries, but also three successive clinical trials overlapping with results is really exciting.

Evelyne: You mentioned some of the future clinical trials that you have planned. Are there any that you would really like to see happen in the next couple of years, if you could design your optimal trial?

Dr. Andy Franklyn-Miller: Absolutely. I think you’ve touched on it earlier. The perimenopausal/menopausal women study is one that’s really quite exciting and one I’d really like to pursue. And also the variation of PeptiStrong with a combination of our other ingredients, which is really exciting in terms of how different pathways can work together. And so the combination of the new results that we’ve got from new clinical trials, but particularly around the menopausal, menopausal women, I think is an area which is needs more work.

Evelyne: Your excitement is definitely contagious. And so I’m curious, clearly Nuritas at the forefront of peptide discovery. So what do you see as the role of peptides in transforming health care in the future?

Dr. Andy Franklyn-Miller: I think peptides, very small ingredients can ultimately make it into everyday food staples in a sort of microdose. So that improves access to patients who can’t afford supplementation or medication. If the end use can be in staples. But there will always be space here because dose responses, individualized prescription, is really the domain that we’re talking today. And Nuritas will work very, very hard in those areas to look at the interactions, dose variations and in very much a practitioner space in terms of unlocking access to data that’s not available in that mass market in terms of FMCG.

So our goal is to produce ingredients in every need vertical. We want to work in every area of health and provide solutions in those, and ultimately improve access to health for everybody rather than those who are just paying for it.

Evelyne: Yeah, that’s really cool. Very exciting. We’re going to wrap up here with some rapid fire questions that we ask every guest. So what are your three favorite supplements for yourself? Obviously one is PeptiStrong.

Dr. Andy Franklyn-Miller: Absolutely. PeptiStrong has be to number one, an undisclosed peptide that we’ve just produced is also my go-to, working on concentration and focus. And then creatine. I think everyone should be on creatine. There’s no excuse.

Evelyne: Very cool. And what are your favorite health practices that keep you healthy, resilient and balanced?

Dr. Andy Franklyn-Miller: You know what? I’m a big believer in the Pomodoro technique. So 30 minute meetings with a five-minute gap in between to change focus. One of the things in starting Nuritas, I had to go back to my biochemistry and peptide days from medical school, having been in clinical practice for a number of years and my first month, literally every 30 minutes, I change topic both in terms of the partnerships we had, the peptide chemistry, mass spectroscopy. And I love it. I love that ability. And I think that keeps things fresh.

Second thing has to be gym for me. You know, lifting weights. It’s that key to longevity and focus. And I think that that’s absolutely vital. And then I’m a theater fan and so I need to I need to have theater once a week somewhere in my life in order to, to make it happy.

Evelyne: Once a week! That’s amazing. Okay. Plays or musicals?

Dr. Andy Franklyn-Miller: Both.

Evelyne: Okay. What’s your favorite musical?

Dr. Andy Franklyn-Miller: Great question. I was in New York and saw Sunset Boulevard with Nicole Scherzinger three weeks ago, and it stands out. It was absolute incredible.

Evelyne: Awesome. Love it, I love musicals. Okay. And final question for you, what is something you’ve changed your mind about through all of your years in this field?

Dr. Andy Franklyn-Miller: I think the ability to understand what food as medicine is about. And so, you know, it was this big category about avoiding processed food, about making choices which were selective and restrictive. And I think what I changed my mind about is that that mission is one that’s very valuable, but it needs to be unlocked without being selective.

We need to be able to give the consumer more choice, via mitigation against those choices, rather than, say, or believe the world is not going to eat processed meat, the world is not going to avoid unprocessed food for economies of scale, for reality. And the world, trying to force people down at push to those products is not going to work.

We need more choice. We need to be able to mitigate against poor choices, or traits. And I think that understanding of how to implement food is medicine. I think it’s been a big shift.

Evelyne: It’s a very interesting thought. And it kind of relates back to improving access for everyone. Right?

Dr. Andy Franklyn-Miller: Yes. And I think lowering that barrier to access is fundamental to Nuritas’s mission.

Evelyne: Yeah. Very interesting. Well, thank you so much, Andy. This was a very insightful conversation. I really appreciated our chat today.

Dr. Andy Franklyn-Miller: Absolutely. Thank you. Absolute pleasure.

Evelyne: And thank you for tuning into conversations for health. Check out the show notes for resources from today’s episode, including the clinical research. Please share this podcast with your colleagues. Follow, rate or leave a review wherever you listen or watch and thank you for designing a well world with us.

Voiceover: This is Conversations for Health with Evelyne Lambrecht, dedicated to engaging discussions with industry experts, exploring evidence based, cutting edge research and practical tips.