00:08:02.680There's a lot of overlap if you made a Venn diagram of what we should generally be eating
00:08:07.600and what may be in a particular diet, but that is an important distinction.
00:08:12.700And 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 table with a patient saying, look, these are some of our options.
00:08:30.300And diet just becomes the obvious choice in so many cases because in general, the risk is low.
00:08:36.920Now, as soon as you start doing more restrictive eliminations, by nature, it can you can run into trouble.
00:08:45.660So you have to be more intentional, more diligent.
00:08:48.220But I think that's such an important distinction because, I mean, you know this more than me.
00:08:52.160The outside community that is critical at best, just name-calling at worst, is looking at these things as a suggestion of an entire lifestyle.
00:09:07.360It's like, look, there's a lot of overlap.
00:09:09.300If more people ate more animal foods and got more animal protein, they feel better.
00:15:15.860And I remember as a kid at SickKids, there was the rheumatoid arthritis, and I think they might have covered psoriatic arthritis too, that like area of the hospital.
00:15:53.480They need to be like differentiated by name, even though at least my opinion is autoimmunity is kind of the same.
00:16:01.180It just manifests differently in different people.
00:16:03.300Which is the frustrating thing to me from a functional clinician standpoint is you can have someone with the same root causes who could get better with the same approaches, but they have two different autoimmune conditions.
00:16:17.840And in describing him in that way, which is not wrong, it's one classification, they look vastly different and you see different specialists.
00:16:27.560which is a question that comes up a lot of times in our clinic
00:17:18.200but then the medications are the same,
00:17:20.420which would make you think maybe the root cause is the same.
00:17:24.140Which is a good, I mean, natural segue for why should we be, I mean, why are we studying these conditions and a dietary approach?
00:17:33.700Well, the current treatments are, they're hardcore medicines.
00:17:38.380They have very real biological effects and side effects.
00:17:42.660We 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 I'm watching sports in the Olympics, are for autoimmune conditions.
00:17:58.880That's what the advertising is for. And they're singing over, get tested for TB and make sure you don't have this condition.
00:18:10.600And it's obviously marketing that's hiding it. But there are very real hardcore medicines that have very real effects. And it just it gets presented as a binary to these patients of, oh, you have this condition, which, again, can have very serious effects.
00:18:31.940So 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 false dichotomy of, well, you know what, nutrition still matters whether you're going to use the medicine or not.
00:18:51.160You know 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.
00:19:02.200So when people, and I had people be like, well, you know, what's your diet? And I was always so offended. And that is an offensive question because it's way more like no one said you should just eat meat.
00:19:14.140Like 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?
00:19:21.160I was like, no, I'm not. But it didn't seem strong enough to counteract the disease I had.
00:19:27.460It was like, oh, yeah, sure. What I'm eating is causing my body to break down.
00:19:31.540Like, that's too much. It doesn't make sense. And I was on methotrexate and Enbro, which is
00:19:38.240etanercept. But I put was put on those when I was like seven and eight, depending on the medication,
00:19:44.880and still had my hip and ankle replaced when I was 17. So I think that's also what made me mad
00:29:25.660be on an elimination diet long term. So no, we don't have the research. And two, I don't really
00:29:31.960want to, by intention, study that specific diet for that long. Now, I think one of our plans is
00:29:38.800with a second sort of protocol is if we can have some folks who we're able to follow up with at
00:29:45.84012 months and say, hey, you know, they're not in the study proper anymore, but hey, are you still
00:29:50.680feeling good what are you doing like i have some tentative plans of kind of a secondary follow-up
00:29:56.460but for the initial study like six months you know 20 24 weeks that's a it's a long period of time
00:30:03.000and we have to be honest of well this hasn't been studied in this way and that's also not
00:30:08.200the goal is again get to this end state of just this elimination diet now comparatively to the
00:30:16.400medicines i would say that is a better clinical state when you're providing nutrition oh yeah
00:30:22.900you're not you know propped up on an immune suppressant keeping things at bay but it's also
00:30:27.960still not like that's still a you know can be a precarious situation and you know especially if
00:30:34.700you're not attending to potentially other things yeah i agree just just to like continue off of
00:30:41.580that so for me in my experience with diet i went into remission pretty quickly uh and that was
00:30:47.740amazing and then i felt great and i think part of that was also getting off of all the medications
00:30:51.980i was on that had a host of side effects that i wasn't even aware of till i stopped taking them
00:30:56.000and i was like oh that wasn't an autoimmune symptom that was a side effect i didn't even
00:30:59.980know that because i'd been on them for so long um but then i was like okay what do i have to do to
00:31:05.640optimize myself so I don't have these huge inflammatory reactions if my steak touches a herb
00:31:12.740which was like that would literally happen I'd have to send steak back because a couple times
00:31:17.720I had steaks with spices on them pretty innocuous spices and then I'd have an inflammatory response
00:31:23.760and I was like well if my body's in the state where I'm that reactive to food still then there's
00:31:29.480something underneath that needs to be fixed however I was in a state of remission so it was like you
00:31:35.140know life's pretty good and i don't like now i can like calm down and relax and start plugging
00:31:40.480away at like what you know what's causing these responses and for me i think it was mainly i think
00:31:46.900it was mainly serious mold exposure um maybe among other things but uh i think that was like a primary
00:31:54.680part of it uh but yeah the goal is diets they have real potential to so we're talking about here of
00:32:02.680i think i used the term you know buying some time to say yeah figure out mold but they also
00:32:07.840themselves have very real potential to help you heal with the things that people have so you know
00:32:14.940this is one of the criticisms that you will probably receive and you know the surface is
00:32:20.440valid is that seems really restrictive and kind of dangerous like how is that ethical and i would
00:32:27.160say okay you want to know how many randomized trials there have been of a vegan diet i looked
00:32:35.080this up a little while ago because i didn't know and depending on the sample size so whether it's
00:32:40.80020 25 people of at least three months duration you're probably into the multiples of dozens
00:32:47.10030 or 40 wow yeah so um there have been so many randomized trials of vegan diets of similar
00:32:56.440duration. And if someone's listening to this, you probably already know this. If not, go ask
00:33:02.660the AI of your choice of Line Up For Me AI, the nutritional profile of a vegan diet side-by-side
00:33:10.820with a carnivore diet. Now, I've tried to train my AI a little bit to not be so, you know, like
00:33:18.300just politically correct. And because the first time I queried, I was curious, what was I going
00:33:26.040say it's like well it's totally hedging like you can do this and i'm like no you you there's there's
00:33:32.420no way in a real practical life you're going to be able to meet that nutrient this nutrient
00:33:36.680oh and it's a vegan diet is like if you also supplement all of these things then it's yeah
00:33:42.020and it's damning when you when you look at this side by side comparison of the nutrient holes
00:33:48.440there with a carnivore diet and this is just you know you can do micronutrients so minerals vitamins
00:33:54.960I 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 three, six months.
00:34:19.280And 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.
00:34:32.800And the big pushback is, well, it doesn't have fiber and the phytonutrients in these things.
00:34:38.300And look, there is clearly a role for some of these compounds.
00:34:42.260Like there's so much study, but I am not going to put them on the same pillar as preformed vitamin A.
00:34:49.280are vitamin B12, things that are established as essential nutrients.
00:34:54.940So I just, yes, on the surface, that's a carnivore diet, lion diet, that's a restrictive diet.
00:35:35.980And 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.
00:35:43.740Like, 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.
00:35:54.180But that's a big criticism that I've heard.
00:35:56.080And 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 to by definition micronutrient poor.
00:36:10.100yeah i think also now that it's been around for a while like i've been publicly talking about it for
00:36:15.900eight years and then there are people who've been on a carnivore diet for longer than me
00:36:20.020and so it's different than a fad diet popping up and studying it right away like well let's
00:36:25.300survive off of blueberries do a blueberry diet can we monitor anyone who's been on it for a decade
00:36:29.960are they still alive like are they doing okay and we have so many anecdotal reports about people
00:36:35.300who are like yeah i've been doing this for 10 years and i still feel good so then the risk is
00:36:40.060dramatically lowered than if we'd done this even though i wanted to do it a long time ago
00:36:43.820if we'd done it a long time ago and also like the the diseases that we're studying and are being
00:36:49.760looked at are like basically deadly diseases eventually back to what we said so then what's
00:36:54.700the risk the stakes are high how is the study staggered so you said there's groups of people
00:37:00.540that are going to be sorted into each diet, then how long do people have to stay on the diet? Is
00:37:07.040there a wean-in process? What does that look like? Yeah. So the current study design is you can
00:37:13.500essentially think of whether someone has ulcerative colitis or Crohn's, so IBD or RA.
00:37:19.760We're stratifying them by disease, but they're taking part in the same study program. So the
00:37:26.980first randomization will essentially be a randomization into one of three groups. So the
00:37:33.460first group will be following a ketogenic diet through some portion of the study program. Second
00:37:41.100will be Lion Diet. The third will be that initial kind of delayed start weightless group. In an
00:37:48.340effort to make the sort of study protocol as, I think, applicable to real life, I wanted to balance
00:37:57.560What are we providing in terms of care versus like just throw a list of eat these foods and good luck?
00:38:09.120Obviously, people can research things.
00:38:13.120But I wanted to balance making an intervention that was really heavy on heavy touch because it wouldn't be as maybe applicable to the population.
00:38:22.900At the same time, these things are hard, right?
00:38:25.220So doing a study where you just give people a list of foods, like, probably wouldn't work out very well.
00:38:32.080So one of the things that we've come up with is trying to on-ramp people.
00:38:36.980So the people that are in the keto or lying group in the beginning, we've intentionally designed it to sort of start as an introduction into low-carb.
00:38:46.460Now, if someone's already doing that, then, you know, I'm not going to say, you know, suddenly do something different,
00:38:52.220But introduce people to the principles of low-carb and help them begin some qualitative eliminations, but some metabolic adaptation.
00:39:01.620Because the fork in the road is you're either going to go ketogenic routes where, okay, further carbohydrate restriction or the lion diet route.
00:39:14.860So the first four weeks of the program are going to follow a lower-carbohydrates, generally-paleo-type diet.
00:39:24.320We are going to have recommendations for dairy in the keto group, because when you think of a keto diet,
00:39:33.140most individuals I see, if they can tolerate it, they're including dairy.
00:39:37.540And dairy on paper, good quality dairy, has great nutritional profile.
00:39:43.220It's not like some of the grains and gluten-containing grains that, even if you can tolerate it, it's not like the nutritional profile, basically non-existent.
00:39:52.600So the keto group will have dairy, but give them this on-ramp.
00:39:58.880And I'm hoping that will, again, help people to adapt more easily so it's not this cold turkey, day one.
00:40:06.960And, you know, if you're lying and you're nowhere close, do this and we're going to deal with the consequences of what's going to happen.
00:40:16.780And so, again, doing this in a supported way and trying to, again, practically help people with things like the electrolytes and food prep.
00:40:26.820I mean, the things that you started to put together, it's like it is it's trying to be practical and help decrease decision fatigue.
00:40:35.320When you're this sick, like you want to just click a button to then, you know, what fault do I need?
00:40:44.840So then when you get to essentially month two, you're now into the sort of the diet proper.
00:40:51.420And right now we basically have plans to have that be for eight weeks.
00:40:55.380So you have the four-week initial on-ramping.
00:40:58.240You have eight weeks of the keto or lion diet.
00:41:02.740And 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.
00:41:12.180So it seems like it's eight weeks and four weeks and 12 weeks.
00:41:17.940It is still kind of a lot of time, but it's also, as you know, not that much.
00:41:24.400And we're going to repeat these markers and see, are we starting to see changes?
00:41:29.020and then at that time the waitlist group will get their randomization so they will be included and
00:41:34.980essentially start where those first groups were where they get the on-ramp month and again they
00:41:42.720know which group they're going into the other groups essentially get to continue and this is
00:41:48.800where we're going to kind of meet with them and they'll get a sort of one-on-one session in the
00:41:54.140middle to kind of strategize and see how are things going what's working again the goal is
00:41:58.880to help folks in the study and to study it as rigorously as we can and what i've put in the
00:42:05.980protocol is we're essentially allowing for at that time point a voluntary crossover so what that
00:42:13.400basically means is if someone started on the keto diet and they got to the week 12 and they don't
00:42:20.100feel like they're improving. For me, as a clinician, this would be what I would normally
00:42:25.540say, okay, I would make an adjustment in the treatment protocol. So we will essentially offer,
00:42:31.320hey, would you like to actually essentially be in the lying group for the final 12 weeks? And vice
00:42:38.560versa. If someone's in the line, they're finding it's super tricky, super challenging, and they're
00:42:42.720getting burned out, and it's troubling, they will have the opportunity at that midpoint.
00:42:48.580And the reason I'm essentially allowing this is, one, is I think it models clinical practice, but two, we're planning from the beginning to do two different statistical analysis.
00:43:00.180One is essentially what's called an intention to treat.
00:43:03.200We're going to see who, look at people from the beginning and the end.
00:43:08.680So you'll see where were they randomized in the beginning.
00:43:14.220And then see where they were at the end, whether they changed groups or not.
00:43:18.580And that basically helps to protect against the, what I'm putting in here as a voluntary crossover, dropouts, things like that.
00:43:25.520It really shows you, if you take 100 people and say, all right, 100 people, do this thing.
00:43:31.720And you're basically getting to the end of like, how many are left?
00:43:34.520But the second analysis, and there's really multiple types of these, but it's called a per-protocol analysis.
00:43:39.780and that allows you to essentially look at well who actually did what to some degree what we
00:43:48.520wanted them to who actually followed the line group or finished in the line who did the keto
00:43:52.800and finish in keto and so those are again what we call per protocol in that they're essentially
00:43:57.260following what the recommendations were so it gives you more of a sense of how did it actually
00:44:05.060perform versus how did me just telling again i made that group a hundred people try this and
00:44:12.820if you're following along you'll see like obviously less people will end up finishing
00:44:19.480the trial from the total group than these you know subgroups so this is why in research
00:44:24.980again the per protocol analysis get looked down upon because like well you cherry picked
00:44:29.640And if you set out from the beginning of like, look, that data is, is both pieces of data 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.
00:44:49.960You don't want to make poor generalizations just because a chunk of people weren't able to do it, which is, unfortunately, that's a part of research.
00:44:59.160So because we have that built into the planned statistical design, I want to allow for that crossover because I think it aligns clinically.
00:45:10.420It's also, again, voluntary and not built into the study design because I think it would be unethical to basically force someone into the other group after, say, they were improving.
00:45:22.940So say you started on the group and line group and you're getting better or keto group and you're getting better and you reach the 12-week point.
00:45:30.280And now we're like, actually, now you need to go back to standard diet or whatever.
00:45:35.060And that's great on paper in the research setting.
00:45:37.900And crossover studies are used all the time.
00:45:40.380But for me as a clinician, not particularly ethical.
00:45:43.700So, again, you're trying to basically balance these factors of, you know, we're trying to help people.
00:45:48.880We want the study to be rigorous, but also we want it to be ethical.
00:45:52.360And we can use different statistical analyses to represent the data fairly.
00:45:57.160And so, yeah, that is sort of the design that we have.
00:46:02.060And again, I made it to try to be efficient because 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, we don't have some massive grant where we can just take as much time as we need and, you know, do all these things.
00:46:20.380I'm trying to have the study be as efficient as possible and to get as much data as we can.
00:47:22.480Even if they don't make it into this first cohort,
00:47:25.520We're going to 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.
00:47:37.000So, again, whenever you're listening to this, even if it's months after, we will likely be still taking folks.
00:47:44.700You know what? I'll put it in the description.