The Doctor Who's Finally Studying Carnivore | Rob Abbott

Why Rob Wanted to Lead This Study

It is easier to be sick than to be [music] well. As a clinician, I'm day in day out taking care of people. I want them to feel better. What's something they're doing every day that can meaningfully [music] impact their health? The logical conclusion you come to as well, start with diet. On the surface, carnivore diet, lion diet, that's a restrictive [music] diet. How can you study that safely?

Okay, do you want to know how many randomized trials there have been of a vegan diet? Line up for me, AI, the nutritional profile of a vegan diet side by side with a carnivore diet. And it's damning. When we first talked, when we were talking about what should the primary outcome be? We're picking a quality of life measure. Well, that's not physiological. That's not a marker of inflammation.

So, that's not objective. If they're not feeling better, they don't care. And I as a clinician, if someone doesn't feel better, I also don't care. That's what really matters. Dr. Rob Abbott, welcome to my podcast. What made you specifically interested in the study lion diet versus keto diet versus standard American diet?

There's many ways I could try to answer this question. We do a really poor job at studying interventions that can actually create health. And I'm not I tell patients I'm not pro-medicine. I'm not anti-medicine. They're different tools in the toolkit. Things have trade-offs. They have effects.

Some of them therapeutic, some not therapeutic. But anything that falls into a drug and even a supplement, a passive therapy, will only have so much potential to really create health. Because the added variable beyond any physiological change like a medicine, a supplement can create, is you need ownership and you need through that empowerment. And that requires some active engagement. It doesn't diet is a huge one. Other things in lifestyle or fall in that category as well. But we study so many things that only at best can can be indirectly involved.

Take a medicine, feel better now, have the ability to do something. That's not nothing, right? You know, and that is a lot of the the model. I don't say, you know, we we do we don't ignore that. But it's limited. It's still not health creation and that's what is most inspiring to me in clinical practice is how do I help relieve suffering for this person right here. And what are the things that they're doing every single day that can have a meaningful impact, not the fanciest, gizmo, gadget, procedure.

And time and place for everything, but what's the what's something they're doing every day that can meaningfully impact their health? And the logical conclusion you come to is, well, we'll start with diet. And we're at a place now unfortunately, it is easier to be sick than to be well. Put another way, it takes more effort to stay well than it is to get sick, which is crazy because on the other hand, we have so much abundance. We have so much relative comfort. We have so much comfort that I was thinking about this the other day. I'm like, I I artificially stress and de-stress myself.

You know, I go work out. I know. I've thought about that, too. It's like we have so much that you actually have to go to the gym instead of just having to work. >> Instead of just being a part of and look, I'm I've chosen a particular career and I'm we try to build our lives in a different way, but it I made that sort of know, a joke, but yeah, it's like artificially trying to meditate, yoga, whatever practice to de- down-regulate my nervous system. I'm also trying to train, and we Yeah, just don't have lives that are as naturally built into the activities and the environments that'll be conducive for for health, and so food becomes even more important, and we're reaching the place where just removing gluten or just removing processed foods it gets people somewhere.

Why Diet Research Is Rare in Medicine

But we're dealing with a mess, and so we're actually having to entertain to me an an elimination diet is processed foods are a given. Like I don't even really think of that when I'm formulating a elimination diet. Like we're now talking about eliminating a some whole food that probably has some nutritional benefit in some context, but we're doing it for this purpose for this individual. And that's crazy to me of you where we're that generally sick and dealing with such a burden of metabolic disease or chronic autoimmune inflammatory disease. These things funnel you back to food, and you realize like there's no money in studying these things because they're not patentable. We're talking about different kinds of food, but that's what really matters, and that's not the stuff that's getting at any academic institution. You get this is the grants are not for these kinds of things.

Like there are people doing them in institutional settings. You know, Dr. uh Terry Wahls, give her so much credit for really pushing forward and getting funding, and it's just not being done there, so at the end of the day it's okay, well someone else isn't going to do this, and I think this research is valid and can be done in a rigorous way. Let's give it a shot. Well, thank you for that. I mean, I guess it does come down to funding. But then back to what you said, it is crazy that we've gotten so sick that there's a subset of people that feel better, I think, eating meat even though that's removing a bunch of foods that are probably nutritionally beneficial. Like, and I've been one of the people that are like in the carnivore crew.

And I've kind of said the whole time like if somebody is reactive to lettuce or like greens or carrots, that's not the picture of health. But if that's also causing inflammatory responses, like we need to get to the bottom of what's what that is because people shouldn't feel better this way, and they are. So, it'd be nice to get some background of what's really, really going on. Children are often the best philosophers. They're always asking, "Why?" How am I supposed to live my life? [music] What is good, right, correct, proper, best? Beauty used to be considered sacred.

What if we replaced this ancient notion of beauty with Do you believe that truths are absolute, or are they all relative? The answers are different in the [music] leading intellectuals. >> What is it that sets apart these thinkers? Plato and Aristotle, [music] Chrysippus, Diogenes, and Marcus Aurelius.

Autoimmune Disease: RA and IBD

Søren Kierkegaard. Ruth Benedict. Philippa Foot. Nietzsche [music] >> is daunting psychologically. He's like a motivational speaker. He's practical in a way that philosophers seldom are. >> Philosophy begins in wonder. I hope that you can [music] take it with you in a further philosophical quest. >> And work out your own answers to the big questions.

So, we're talking about studying and what we're trying to study here are elimination diets, which for me as I was alluding to, a diet should be for a specific period of time, for a specific context, with a therapeutic goal. It's not it's different from a way of eating. Like there's a lot of overlap if you made a Venn diagram of what we should generally be eating and what may be in a particular diet, but that is an important distinction and from a medical lens, that's why I look at it in the same way as a medicine or a supplement and I bring it to the to the table with a patient saying, "Look, these are some of our options. This is what we can expect." And diet just becomes the obvious choice in so many cases because in general, the risk is low. Now, as soon as you start doing more restrictive eliminations, by nature, it can you can run into trouble. So, you have to be more intentional, more diligent, but I think that's such an important distinction cuz I mean, you know this more than me, the the the outside community that is critical at best to just name calling at worst, is is looking at these things as like a suggestion of an entire lifestyle.

And it's like, "Look, there's a lot of overlap." If more people ate more animal foods and got more animal protein, they they feel better. That's what I see in practice. That's what so many other people see. But we're not saying take someone off the street, "Oh, you need to go do a carnivore diet just because I think so." It's like, no, we're talking about in this case like systemic autoimmune conditions that are causing disabling symptoms and have very real consequences. The stakes are different than if someone just says I mean they could be oblivious but tells you I feel fine.

Well, I'm not going to just tell them go do this restrictive diet. I feel that's just such an important distinction to make. You've probably been frustrated by that. I'm frustrated when you try to research something and it gets muddled into where you're just telling people to do this. Like no, this is this is not what we're doing. >> It's also it's a net negative because trying to sell So when when I was early on in the diet I probably had some videos being like yeah, everyone should try this. And that's because my life completely changed and I felt completely different and I was like this is crazy. Everyone should at least try this for a period of time. >> arc with insert any other It's like it's the normal arc.

Yeah. Yeah. And so totally understandable and then after a couple of years I think it probably took a couple of years or maybe a year. I kind of pivoted to well, people I can at least as a blanket statement say that anybody with a psychiatric issue and or an autoimmune issue that hasn't been helped by the medical system should try that. And that's kind of what I've stuck with for the last 7 years is like if you're on a bunch of meds and you're still chronically ill and you're you're getting worse or you're staying the same then what harm is an elimination diet compared to what you've already what you're on or what you've already been through or the disease itself? Like there's no harm here compared to not doing anything one or trying some of the new medications which usually come with problems. But yes.

That is a differentiation for sure. That's important. So with this study I guess we could really get through for people interested if they still want to participate. Who can we take? And apologies it's there's like a certain number of people it's not a certain number but it's there's a certain type of person we're looking for and that's not because we're trying to be annoying it's because this is this is how annoying scientific studies are and you like you have to fit a certain criteria and it's not fair but hopefully is really being done to push research along and so it is what it is. What we are aiming to to study in particular are two systemic autoimmune conditions. So, rheumatoid arthritis and then a collection that are of autoimmune conditions that are under the header of inflammatory bowel disease.

The two that we are including are the kind of the most notable and potentially most severe, which are Crohn's disease which can affect basically any segment of the GI tract versus ulcerative colitis. The name kind of tells you it's located in the large intestine or the colon. And that is an important distinction.

Why Diet May Affect Autoimmune Disease

We've had some folks reach out with forms of microscopic colitis, which depending on the classification are considered inflammatory bowel diseases and differentiated from something like IBS. But that collection is a little trickier and sometimes can even be caused by a singular variable. So, you'll actually I think I mentioned this at one point in a text, you know, given your history with SSRIs. I had one patient who had microscopic colitis basically solely from an SSRI. Oh. And so, we actually had to do a double taper of I, you know, using steroids to help acutely with the symptoms while getting cuz you can't crash off of SSRIs. And actually today she's off off both of them, doing great. >> amazing. >> And so, there's a lot more there on the SSRI side, but a great example of and it's documented with non-steroidals that you can get you can have something like that be more singular cause and that's not great for a study cuz it could it can go both ways.

One, someone stops it, they get better and you say it was the diet. Well, got rid of the medicine or vice versa, someone doesn't get better and it's because they're still taking in something that's causing such a unique reaction. So, I apologize for that subset very real debilitating symptoms, but for our study ulcerative colitis and Crohn's disease. And the reason that we're wanting to include two conditions. One is we want to get as many people as we can, which at the time of filming here we are would love as many participants that are that are interested. But it also allows us within the study design to have more than just one disease subset. Even when we first reached out, I was like, man, I want to do all the study all the autoimmune conditions because a lot of the psoriatic arthritis, they don't have they don't get some of the same research.

IBD has probably the most diet specific research of any intervention, but RA pretty limited. These other conditions even more limited. We want to include these conditions because they while they have their tissue specific, they're very systemic. I mean, markers of inflammation that you can measure in the blood tell you this is a systemic condition. It's not just an isolated little inflammation in in the bowel. But our goal is in the future to be able to include others that are in these other subsets, psoriatic arthritis and other conditions. Lupus would be good.

I was frustrated not not to interrupt, but I remember so when my arthritis wanted to remission with diet, I was like, this is crazy cuz I I didn't just have joint pain. I had like joints, people know this, but I had joints removed from like being broken down. This was really severe arthritis. And I remember as a kid at Sick Kids, there was the rheumatoid arthritis and I think they might have covered psoriatic arthritis, too, that like area of the hospital, and right next to it was lupus. And I But the doctors didn't talk to each other because they were considered separate diseases. And I remember being like, "Okay, how are they separated exactly?" So, the problem with the science scientific studies is they need to be specific, even if it's likely that if these diets do make an impact and work, that'll happen across the board.

So, people should know that. They need to be like differentiated by name, even though, at least my opinion is autoimmunity is kind of the same. It just manifests differently in different people. Which is the frustrating thing to me from a functional clinician standpoint is you can have someone the same root causes who could get better with the same approaches, but they have two different >> Yeah. autoimmune conditions, and in the in in describing them in that way, which is not wrong, it's one classification, they look vastly different, and you see different specialists. Yeah. Which is a question that comes up a lot of times in our clinic of, "Can you help insert X condition?" And it's like, "Well, from the functional lens, I'm I'm feel comfortable with anything.

And I've a family medicine background, kids, adults, it you know, doesn't matter, but the functional lens looks just like you said, I'm actually looking at you know, similar people, you know, similar diets, similar environments. They manifest differently because of unique genetic predispositions and other elements of of family history, but there's far more similar. It's like, you know, picture the iceberg. The beneath the surface, like you just see the outside, "Oh, this looks different." And then like, "Wait, but it's way more beneath the surface. It's actually way more similar." >> Well, and they're treated e- even in the medical system, they're treated by similar drugs, if not the same drugs. So, they're put into different categories and treated by different specialists, but then the medications are the same, which would make you think maybe the root cause is the same.

Which is a good, I mean, natural segue for why should we be why are we studying these conditions and a dietary approach? Well, the current treatments are they're hardcore medicines. They have very real biological effects and side effects. I we laugh at the commercials, which if people are paying attention to commercials, I think the vast majority of them, at least the ones that I'm seeing when watching sports in the Olympics are are for autoimmune conditions. Like, that's what the advertising is for. And like, they're singing over, you know, get tested for TB and make sure you don't have this in condition and it's obviously marketing that's hiding it, but they're very real hardcore medicines that have you know, very real effects and Yeah. >> it just it gets presented as a binary to these patients of, "Oh, you have this condition." Which again can have uh very serious effects.

So, then we must match this with something that is equally seemingly powerful. Which is, okay, can be life saving in certain situations, but is a is a false dichotomy of, "Well, you know what? Nutrition still matters whether you're going to use the medicine or not." >> what? One of the reasons I think it took me, and I was young when I started to look into nutrition, but one of the reasons I scoffed at it for so long was because my arthritis was serious enough to have joints replaced.

Elimination Diets Explained

So, when people and I had people be like, "Well, you know, what's your diet?" And I was always so offended. And it that isn't an offensive question being cuz it way more like, no one said you should just eat meat. Like that would have been I would have been like that's something to actually think about probably, but they were just like, "Well, are you eating? Are you surviving off of candy?" And I was like, "No, I'm not." But it didn't seem strong enough to counteract the disease I had.

It was like, "Oh, yeah, sure. What I'm eating is causing my body to break down." Like that's too much. It doesn't make sense. And I was on methotrexate and Enbrel, which is etanercept. Um but I put was put on those when I was like seven and eight, depending on the medication, and still had my hip and ankle replaced when I was 17. So, I think that's also what made me mad cuz it reduced my inflammation.

So, I went from like being basically off and on in a wheelchair when I was in grade two and three to running around and playing soccer almost immediately when I went on uh etanercept. And that was crazy and we're like, "Wow, what a miracle." And then at 17 I had my hip and ankle replaced cuz there was no cartilage and there was bone damage. And it was like, "That doesn't seem like a long-term solution." Plus there were all the side effects and they were like, "There is >> a complete scam. I'm from Canada, too, and I found out how much it costs for like schools in the States. It's almost unfathomable.

Peterson Academy, if you want an actual education, join up. The Progressives hope for universal education at something approximating zero cost. That's what we've got. They're the best courses [music] that have ever been offered publicly in terms of their quality of content and also the production values are unparalleled. Right now, one of the key things with this study is we want to understand some of the physiological changes that are happening. Now, this being said, my background is a clinician. I'm day in day out taking care of people.

I want them to feel better. When we first talked, when we were talking about what should the primary outcome be? What's the main study measure we want? Well, we're picking a quality of life measure. Which a reasonable critique is, well, that's not physiological. That's not a marker of inflammation. So, that's not objective.

You're using a subjective questionnaire. My counters to that would be yes, people like seeing blood work change. If they're not feeling better, and not from just suppression of symptoms, but if they're not feeling better, they don't care. And I as a clinician, if I'm evaluating the efficacy of something, someone doesn't feel better doing something, I also don't care. So, having a primary outcome that is a yes, subjective, which is actually the important part, scale for their perception of their health is to me, like, that's how dietary and lifestyle interventions should should be studied. We're using one that is multi has multiple components. It's you know, quite well validated.

I've used it in, you know, previous studies and it has been helpful to see changes in not just physical health, but emotional health and capacity, which again, it's it's it can be difficult to quantify those, but are so real to the people that you talk about when they have these conditions of I didn't go out and do this thing because I'm in incredible debilitating you know, debilitating joint pain. So, but we we need the physiological data as well. And so, several of our I'm calling them sort of our safety analysis. They would be probably technically under secondary outcomes.

Comparing Keto and Carnivore Diets

We're trying to get as much nutri you know, micronutrient data, metabolic data to understand what's happening with these people when they're when they're changing these diets because we have a whole bunch of n equals one. And what's interesting is you know, one person's physiology, you know, one person's physiology. There's so many fascinating things that you will see even with the same diet. Just last couple weeks I've had people on carnivore diets who have very low LDL cholesterols. Other folks, you know, very high LDL cholesterols. So, we want to measure a number of nutrients, lipids, metabolic markers alongside of the subjective not because you know, the the the physiological should have been more important, but we need to understand what's happening. And I guess it's also important to note that this study is is meant to be controlled and it's in a randomized setting.

It's still technically a pilot. So, normally in the sequence of how you would do a study it would start more as like a really small group of feasibility observation. And we're trying to basically bake that in to a more rigorous study design. One because the critics are going to say, you know, "Oh, you had 10 people who did you know, carnivore. That's not enough." And I'll say, "Well, yes, but you know, got to start somewhere." So, we're actually trying to get a larger sample, control it with a basically someone's baseline diet.

But it's still technically a pilot. So, in those pilots, that's where you're getting more physiological data and those are typically more in sort of safety analysis. They're not like the primary income or the primary outcome measure. You're trying to see what happens with a bunch of folks start reducing carbohydrates, eliminating, you know, food groups. And so, I'm I mean, I'm really interested to see what what changes because um and and that's a big amount of the sort of study budget which we is trying to go to getting as much information on the physiological side as we can. This stool testing to look at changes in obviously calprotectin for IBD, but in microbiome and digestion. So, we're trying to get as much data there, but you know, it's just important to note that yes, the actual primary outcome measure what we don't want to miss with all of the numbers and and the blood work is is this person feeling better after following said diet.

And that can you know, we can't lose that in the in the big picture. >> No, and I think we're also throwing a wide net for like blood markers, stool sample, because people really don't know what the pattern is when when people change their diet. When people go on the carnivore diet, like you said, some people's LDL goes up, some people's goes down, some people's doesn't change. There haven't been any studies that show an actual pattern of like what marker actually changes or how does the microbiome actually change? So, that's kind of secondary out of interest to see if any patterns emerge, but yeah, primarily we want to see do people feel way better if they go on a all meat diet or a keto diet versus staying on the regular diet. And that was one of the in trying to come up with a study design that could have begin to give us data to answer some of these questions was entertaining the idea of how much of this is the metabolic you know, ketogenic state versus the qualitative change in eliminating uh plant foods. And so, the reason we actually have a randomization for uh the you know, carnivore lion group versus a keto group is to kind of control for some of that metabolic change. Now, we don't totally know what an individual if they will go into a higher or lower degree of ketosis when they're following lion versus keto.

Again, on paper, that's what the macronutrient profile is, but you know, that's why we want to measure blood ketones and and glucose. But that was one of the key control variables of if we can randomize and have that, we can start to answer well, does the person get better? Do they just need to be keto and it's the metabolic adaptation? Or do some people need more because of other factors? And then the third control being sort of a nested cohort. So, out of the the the groups, I'm actually having a subset. Essentially, it's like a delayed start.

So, I'm calling it a waitlist delayed start. They're essentially the the same thing for this. So, we're instead of giving them any dietary guidance in the beginning going to say keep doing what you're doing. They're going to still tell us what they're eating so we can see if someone starts eating carnivore on the waitlist group, like they're going to show us that, but we're not going to give them any kind of So, they're going to be on their their baseline.

Why Doctors Rarely Prescribe Diet

And then essentially 12 weeks in or halfway in, they will then get to you know, we'll randomize them to one of the the diet groups. So, they're actually going to be this cool little nested group of people that were essentially getting no dietary advice on probably varied, you know, individual diets are going to vary. And then getting a specific diet and seeing how did that change and being able to compare them and any changes that they have to the folks that start in the beginning on either keto or or lion and then seeing, you know, how can they can they sustain that? And I know a few people reached out and were like, you need to study this for a year and, you know, longer and You think we're just going to stop? >> my counter to that is one Go you, do it. >> got to We got start somewhere. Also, back to >> is pretty good. >> Also, yes, to the pilot, like This is, to my knowledge, the first effort at any randomized trial of a corner carnivore diet. So, um and if we're going back to the goal is temporary elimination to get you better with some hope of reintroduction, like buying some time to maybe find if there is another root cause, like mold. Like, the goal isn't get on the In the same way that we were saying the goal in game with the medicine shouldn't be be on the medicines.

That's it. Like, the goal isn't be on an elimination diet long term. So, no, we don't have the research, and two, I don't really want to buy into this study that specific diet for that long. Now, I think one of our plans is with the second sort of protocol is if we can have some folks who were able to follow up with that at 12 months and say, "Hey, you know, they're not in the study proper anymore, but hey, are you still feeling good? What are you doing?" Like, I have some tentative plans of kind of a a secondary follow-up. But, for the initial study, like 6 months, you know, 20 you know, 24 weeks, that's a that's a long period of time, and we have to be honest of, well, this hasn't been studied in this way, and that's also not the goal is, again, get to this end state of, you know, just this elimination diet.

Now, comparatively to the medicines, I would say that is a better clinical state when you're providing nutrition and you're not, you know, propped up on a an immune suppressant keeping things at bay, but it's also still not like that's still a can be a precarious situation, and, you know, especially if you're not attending to potentially other things that are going on. So, just just to like continue off of that. So, for me, and my experience with diet, I wanted to remission pretty quickly uh and that was amazing and then I felt great. And I think part of that was also getting off of all the medications I was on that had a host of side effects that I wasn't even aware of till I stopped taking them and then I was like, oh, that wasn't an autoimmune symptom, that was a side effect. I didn't even know that cuz I'd been on them for so long. Um but then I was like, okay, what do I have to do to optimize myself so I don't have these huge inflammatory reactions if my steak touches a herb? Which was like that would literally happen.

I'd have to send steak back because a couple times I had steaks with spices on them, pretty innocuous spices, and then I'd have an inflammatory response and I was like, well, if my body is in the state where I'm that reactive to food still, then there's something underneath that needs to be fixed. However, I was in a state of remission, so it was like, you know, life's pretty good. And I don't like now I can like calm down and relax and start plugging away at like what, you know, what's causing these responses. And for me, I think it was mainly I think it was mainly serious mold exposure. Um maybe among other things, but uh I think that was like a a primary part of it. Uh but yeah, the goal is >> they have real potential to So, we're talking about here of I think I used the term you know, buying some time to say, figure out mold, but they also themselves have very real potential to help you heal with the things that people have. So, >> 100%. you know, this is one of the criticisms that you know, we'll probably receive and you know, on the surface is valid is that seems really restrictive and kind of dangerous.

Like, how is that ethical?

Vegan vs Carnivore Randomized Trials

And I would say, okay, um you want to know how many randomized trials there have been of a vegan diet? I looked this up a little while ago cuz I didn't know. And depending on the sample size, so whether it's 20, 25 people of at least 3 months duration, you're probably into the multiples of dozens, 30 or 40. >> Wow. Yeah, so um there have been so many randomized trials of vegan diets of similar duration. And if someone's listening to this, you probably already know this. If not, go ask the AI of your choice of line up for me AI the nutritional profile of a vegan diet side by side with a carnivore diet. Now, I've tried to train my AI a little bit to not be so, you know, like just uh politically correct.

Um and cuz the first time I queried, I was curious, what is it going to say? It's like, well, it's totally hedging. Like, you can do this. And I'm like, no, you you there's there's no way in a real practical life you're going to be able to meet that nutrient, this nutrient. Oh, with a vegan diet it's like, if you also supplement all of >> Yeah. And it's And it's damning when you when >> when you look at the side-by-side comparison of the nutrient holes there with a carnivore diet. And this is just, you know, you can do all micronutrients, so minerals, vitamins.

Then I mean, there's the obvious ones, but and then you go into the amino acids, so building blocks for protein. It is it is wild. And so you look side-by-side and you say, okay, well, we set a precedent, maybe a wrong one, but we set a precedent that it's okay to study vegan diets to treat, you know, to maybe induce weight loss or treat a condition for 3, 6 months. I don't think we can say, if that's the precedent, it's not okay to study an animal-based approach when if you actually compare the micronutrient profile, they're not even close. And the big pushback that is well, it doesn't have fiber and the phytonutrients in these things. And look, there's there is clearly a role for some of these compounds. Like there's so much study.

But I am not going to put them on the same pillar as preformed vitamin A or vitamin B12, things that are established as essential, you know, nutrients. So, I just, you know, yes, on the surface that's a, you know, you know, carnivore diet, lion diet. That's a restrictive diet. That's like how can you study that safely? Well, again, my counter is well, go look what we've been doing with the vegan diet. Not saying that was right, but the precedent is is there. Um again, we're also going to be monitoring labs to see what changes are happening.

But when I looked at that, I was like, wow, the discrepancy between how much emphasis has been placed there. And and you see that in the guidelines. Like they love plant-based, whatever that means. It's like vegetarian by some other silly name. It's it's crazy how that has penetrated. And it's why I think this research matters is people are paying attention to that literature, even if it's bonk and done poorly and should have like, you know, it's like if you if you did follow that person for longer and you didn't just look at their lipids and say, well, that was the end goal. You're going to see some things fall off the wagon pretty quick.

Um but that's a big criticism that I've heard. And it's like I said, it's like really, if you dig into the details here, like this is far more reasonable to study in a controlled setting than something that is like a priori start the by definition micronutrient poor. Yeah, I think also now that it's been around for a while, like I've been publicly talking about it for 8 years. And then there are people who've been on a carnivore diet for longer than me. And so it's different than a fad diet popping up and studying it right away. Like well, let's survive off of blueberries, do a blueberry diet. Like can we monitor anyone who's been on it for a decade?

Are they still alive? Like are they doing okay? Yeah. And we have so many anecdotal reports about people who are like, "Yeah, I've been doing this for 10 years and I still feel good." So then the risk is dramatically lowered than if we'd done this, even though I wanted to do it a long time ago. If we'd done it a long time ago. And also like the the diseases that we're studying and are being looked at are like basically deadly diseases eventually.

Back to what we said, the stakes are high. risk. The stakes are high. How is the study staggered? So you said there's groups of people they're going to be sorted into each diet. Then how long do people have to stay on the diet? Is there a weaning process? What does that look like?

Yeah. So the current study design is you can essentially think of whether someone has ulcerative colitis or Crohn's, so IBD or RA. We're stratifying them by disease, but they're taking part in the same study program. So the first randomization will essentially be a randomization into one of three groups. So the first group will be following a ketogenic diet through some portion of the the study program. Second will be lion diet. The third will be that initial kind of delayed start weight loss group.

In an effort to make the so the study protocol as I think applicable to real life, I wanted to balance like what are we providing in terms of care versus um like just you know, I'm not going to just throw a list of "Eat these foods and good luck." Um obviously people can research things. You've curated so many resources. But I wanted to balance making an intervention that was really heavy on a heavy touch because it wouldn't be as maybe applicable to the population. At the same time, these things are hard, right? So, doing a study where you just give people a list of foods like probably wouldn't work out very well. So, one of the things that we've come up with is trying to on-ramp people.

So, the people that are in the keto or lion group in the beginning, we've intentionally designed it to sort of start as an introduction into low carb.

The Largest RA and IBD Diet Study

Now, if someone's already doing that, then you know, we're not going to say you know, suddenly do something different, but um introduce people to the principles of low carb and help them begin some qualitative eliminations, but some metabolic adaptation because the fork in the the fork in the road is you're either going to go the ketogenic route where, okay, further carbohydrate restriction or uh the lion diet route. So, it was a natural progression. So, the first 34 weeks of the program we're going to follow a kind of a lower carbohydrate generally paleo-type diet. We are going to have recommendations for dairy in the keto group cuz I think that's a like when you think of a keto diet, and most individuals I see, if they can tolerate it, they're including dairy in dairy on paper, good quality dairy has great, you know, nutritional profile. It's not like some of the grains and gluten-containing grains that, you know, even if you can tolerate it, it's not like the nutritional profile basically nonexistent. So, um the keto group will have uh dairy, but given this on-ramp, and I'm hoping that will, again, help people to adapt more easily, so it's not this cold turkey day one. Yeah. >> if you're lion and you're nowhere close, do this and you know, we're going to deal with the the consequences the the the what's going to happen.

So, And again, doing this in a in a supported way and trying to get in practically help people with things like the electrolytes and food prep. I mean, the things that you started to put together and it's like it is it's trying to be practical and and help decrease decision fatigue. When you're this sick, like you want to just click a button to then, you know, what salt do I need? Okay. Yeah. Um but have this on-ramp month, so that then when you get to essentially month two, you're now into the sort of the the diet proper. And right now, we basically have plans to have that be for 8 weeks, so you have a 4-week initial on-ramping, you have 8 weeks of the keto or or lion diet.

And then we'll reach kind of the midpoint of the study where some of the main tests that we did at the beginning, questionnaires, we'll run them again. So, you know, I think it seems like it's I think like 8 weeks and 4 weeks and 12 weeks it is still kind of a a lot of time, but um it's also, as you know, not that much and we're going to repeat these markers and see are we starting to see changes? And then at that time, the waitlist group will get their randomization, so they will be included and essentially start where those first groups were, where they get the on-ramp month and again, they know which group they're going into. The other groups essentially get to continue and this is where we're going to kind of meet with them and they'll get a sort of one-on-one session in the middle to kind of strategize and see how are things going, like what's working. Again, the goal is to help folks in the study and to study it as rigorously as we can. And what I've put in the protocol is we're essentially allowing for at that time point, um a voluntary crossover. So, what that basically means is if someone started on the keto diet and they got to the week 12 and they don't feel like they're improving for me as a clinician, this would be what I would normally say, "Okay, I would make an adjustment in the treatment protocol."

So, we will essentially offer "Hey, would you like to um, actually essentially be in the lying group for the final 12 weeks?" And vice versa, if someone's in the lying they're finding it super tricky, super challenging, and they're getting burned out, and and it's troubling, they will have the the opportunity at that midpoint. And the reason um, essentially allowing this is one is I think it models clinical practice, but two we're planning from the beginning to do um, two different statistical analyses. Uh, one is essentially what's called an intention to treat. We're going to see you who look at people from the beginning and the end. So, you'll see where were they randomized in the beginning? Did they start in the keto group?

Did they start in the lying group? And then see where they were at the end, whether they changed groups or not. And that basically helps to, you know, protect against the when I'm putting in here as a voluntary crossover, dropouts, things like that. It It really shows you if you take 100 people and say, "All right, 100 people do this thing." And you're basically into the end of like, "How many are left?" Like, um, but the second analysis, and there there's really multiple types of these, but it's called a per protocol analysis. Uh, and that allows you to essentially look at well, who actually did what to some degree what we wanted them to.

Who actually followed the lying group or finished in the lying? Who did the keto and finished in keto? And so, those are again, what we call per protocol in that they're essentially following what the recommendations were. So, it it gives you more of a sense of how did it actually perform versus how did me just telling again I made that group with 100 people try this and if you're following along you'll see like obviously less people will end up finishing the trial from the total group than these you know subgroups. So this is why in research again you know the per protocol analysis get looked down upon cuz like well you cherry picked. Again if you set up from the beginning of like look that data is is both pieces of data that are helpful. You want to see how hard is this but you also want to see of the people who did it how did they do?

So that if someone is able to follow they have some direction on oh okay that person was able to this group of people were able to follow the diet and they saw these changes. You don't want to make poor generalizations just because you know chunk of people were able to do it which is unfortunately that's a part of research.

How the Study Is Designed

Um so because we have that built into the planned statistical design I want to allow for for that crossover because I think it aligns clinically. It's also again voluntary and not built into the study design because I think it's it would be unethical to basically force someone into the other group after say they were improving. So say you were started on the group and lying group and you're getting better or keto group and you're getting better and you reach the 12 week point and now we're like actually now you need to go back to Yeah. standard diet or whatever and that's great on paper in the research setting and crossover studies are used all the time but it's for me as a clinician not particularly ethical. So again you're trying to basically balance these factors of you know we're trying to help people. We want the study to be rigorous but also you know we want it to be ethical and we can use different statistical analyses to represent the data fairly and you know so um yeah that is sort of the the design that we have and again, I made it to try to be efficient cuz the whole point of the study as well is you know, it is crowdfunded by so many people probably listening who are so generous of you know, where we don't have some, you know, massive grant where we can just take as much time as we need and, you know, do all these things. We Well, I'm trying to have the study be as efficient as possible and to get as much data as we can. So, I'm so excited.

Well, Dr. Rob, I think the sun is setting. >> setting. The sun is blinding. It's [laughter] blinding. Dr. Rob, thank you so much for taking this on. I'm really excited to see the results and to meet people who are going to be in the study.

So, we would love more participants. We're sorry if we had to say no, but hopefully there'll be future studies and hopefully the study will help way more people than are part of it anyway. That's the point. Where can people find you online? Yeah, the last thing I'll say with the the study is we're already planning there's going to be at at least two cohorts of groups. So, with our intended goal sample size for the statistical analysis, we're not going to have all of these folks in the first group. So, if you're listening to this and you know someone or you yourself, like please fill out the survey, please share this.

Um even if they don't make it into this first cohort, we're going to be, you know, it's it'll be rolling eligibility for a second cohort because we want to get as many people as we can to improve the power of the study. So, again, where whenever you're listening to this, even if it's you know, months after, we will likely be uh still taking folks and >> You know what? I'll put it in the description. So, I'll say study still open. Yeah. And then if it ever stops, which it will eventually, I'll just have studies now closed before the link. So, assume it's open.

And I'm looking forward to one of the cool things will be we're getting data even again if we're in the first cohort and we haven't reached our end goal for the final analysis and our goal publication. I'm really excited to be able to share in a real time as we're going along what are some things that we're seeing in the study. So, even before getting to the publication which is kind of elements of common practice when people are sharing data elements of data conferences. But, because of the crowdfunding nature and what folks are investing into this I want to the goal is to be as transparent as possible and to share some of the things that we're learning along the way. And because we're getting so much data it's not all going to be in the first iterations of things. We will we want to get as much data as we can. If it's not in analysis it's because we couldn't get it which is again just part of research and definitely part of diet research in terms of getting people to do forms and do all the things that you want them to do.

So, I'm really actually looking forward to to that. And your original question was where can people find me? Yeah, and I'll tag all your socials in the description so people can press. Thank you so much for coming on. Thank you for doing this. Thanks for reaching out.

Measuring Results: Symptoms and Biomarkers

And we will share all the results and updates throughout this with everybody. So, let's see what happens. And if you'd like to be take part in it, please apply or support if you want to support it. But, applicants first and foremost please. >> Yes, please. As many as many as we can get we would truly love to have folks. And the folks who have reached out and who were who we've we've been in contact with I'm so grateful and yeah, this is very exciting. So. >> Oh.