Can Keto Help Treat Bipolar & Schizophrenia? A New Trial Explores Its Potential

Carlo: 
The response I’ve had ever since this idea came into my mind, which is about five years ago, from our patient has been phenomenal. Because it’s not just we are looking at diet, right? We are looking at what can we do to give you control back in your life. It’s not just about I, doctor tell you what medication you should take.

It is about taking control back in your life.

Bret: 
Welcome to the Metabolic Mind Podcast. I’m your host, Dr. Bret Scher. Metabolic Mind is a nonprofit initiative of Baszucki Group where we’re providing information about the intersection of metabolic health and mental health and metabolic therapies such as nutritional ketosis as therapies for mental illness.

Thank you for joining us. Although our podcast is for informational purposes only and we aren’t giving medical advice, we hope you will learn from our content and it will help facilitate discussions with your healthcare providers to see if you could benefit from exploring the connection between metabolic and mental health.

A powerhouse team of researchers from Australia is launching a new randomized controlled trial of a ketogenic diet versus the Australian Healthy Eating Guidelines to see how it impacts schizophrenia and bipolar disorder. So, let’s hear from Dr. ZoltÃn Sarnyai, Dr. Carlo Longhitano, and dietician JJaymee-Leigh Swift.

Alright, Zoltán, let’s start with you. I’m really excited to talk to all of you about this trial, but tell me what motivated you to start this trial. What even gave you the idea behind it? 

ZoltÃn: 
Yeah, so let me start with a little bit of a history. Over 10 years ago, my lab was very interested in figuring out some novel pathophysiology of schizophrenia and other psychotic disorders. We mostly used animal models at the time, preclinical models of schizophrenia. And there already had been a lot of indications that there might be an underlying bioenergetic abnormality, systemically elevated glucose.

There was insulin resistance, which we were able to replicate even in our pharmacological animal models. So, I was really interested in figuring that one out a little bit. And then we started thinking about intervention. I have to admit, accidentally bumped into the epilepsy field and the the ketogenic diet story there.

And it immediately offered some really interesting opportunity here. Because back then, about 10 years ago, there was actually quite a lot of then newly emerging transcriptomic and proteomic evidence that the glycolytic pathway seems to be affected in schizophrenia, and abnormalities were found in postmortem samples and all of that.

So, if that is true, I reason then using ketogenic diet circumventing this abnormal functioning glycolysis might be an interesting potential therapeutic approach. So, we set that up in a pharmacological animal model of schizophrenia.

We put mice on ketogenic diet for three weeks, and we used what’s called a hypoglutamatergic model of schizophrenia using a pharmacological antagonist for the NMDA glutamate receptor. By the way, similar molecules in use psychosis is in humans as well. So, it does have some validity. And pretty much to our surprise, this model replicates many aspects of what we see in the human schizophrenia spectrum in terms of stereotype behavior, abnormal sensory motor gating, working memory deficits, impaired sociability and all that. So, we were able to see that in our animals. and all of these behavioral science, they were completely normalized in the ketogenic diet-treated animal.

So, that was really exciting to see. But of course, an animal model never captures the whole neurobiology and symptomatology of a complex human disorder. So, what we can do in the lab is to go for converging evidence, and that’s what we have done. We set up models of different nature, not just pharmacological, but also a neurodevelopment and genetic model and ketogenic diet in a very similar manner in all of these different animal models.

So, that actually stimulated me starting to think about moving this to the clinic. We knew that this is a reasonably safe approach because it has been used over a long time in another area of medicine in neurology.

And we thought that If nothing else, there should be an improvement in overall metabolism. Because issues associated with long-term antipsychotic use, like hypoglycemia, insulin resistance, type 2 diabetes, metabolic syndrome, they are actually quite attractive targets for an approach like ketogenic diet.

Anyway, so I was very keen to get started with a clinical trial, which we had absolutely nothing for at that time. And I think one of the main moments of this whole progress of these ideas was my chance encounter with Carlo Longhitano. Dr. Longhitano, when I gave a talk to the psychiatrist at the hospital and talked about our preclinical data. And there he was, a psychiatrist who showed interest in that. And we started talking and and we got together, started outlining this clinical trial. Again, at the time, it was just an idea, no funding. But I think both of us were very committed to make this happen. 

Bret: 
Yeah, what a great answer. From a true scientist, like coming from the mechanistic hypothesis to the animal data to then the human trial.

Like really working your way up through the scientific process. So, it’s not just throwing it at the wall to see what sticks. But really planned out and thought out and researched ahead of time. And then, of course, as you mentioned, your encounter with Carlo. So, let’s talk about it a little bit from the clinical side of things where sort of psychiatric care falls short right now, and how this research study could potentially play into that to help that. How do you see that approach? 

Carlo: 
Yes, and thank you, ZoltÃn, for introducing the topic. And I do remember meeting you at that lab meeting, and it was transformational.

The reason for that is because I am a clinical psychiatrist with 20 plus years experience in dealing with psychiatric morbidity, and seeing the struggle that our patients do have in treating the mental disorders. And in spite of my best efforts, and my trajectory comes across several countries from Italy to the UK and Australia, I saw it over and over again.

People with schizophrenia, bipolar, treatment is not enough. Medication is not enough. And I’ve always been a passionate advocate that yes, let’s talk about medication, but let’s also look at your life. Let’s look at what your dreams are. Let’s look at how you eat and how you sleep and how much exercise you do.

I’ve always done that naturally. So, when you came around, Zoltán, and did talk about the ketogenic metabolic pathway to brain health, I was really fascinated and said, yeah, but that makes sense. And maybe there is something much more profound than just a general lifestyle intervention? Maybe that has a translation at mitochondrial level or brain energy metabolic pathway levels that has a fundamental effect on the pathogenesis of mental disorders?

So yeah, so I was sold very much straightforward. And yes, we had no means in the beginning. And I’m extremely grateful to Baszucki for providing those means sometime later. And I can see how this protocol is now come together after many conversations with yourself, with the team that we slowly built and with international community of metabolic, researchers in mental health.

So, the list of thanking that I have in mind is extremely long. But focusing on this protocol, I think what we did particularly care about was to make sure that we were able to deliver the science behind what translates from the idea of bioenergetic abnormality to the practice of delivering something that people can use on a day-to-day basis.

And the response I’ve had, ever since this idea came into my mind, which is about five years ago, from our patient has been phenomenal because it’s not just we are looking at diet, right? We are looking at what can we do to give you control back in your life. It’s not just about I, doctor tell you what medication you should take.

it is about taking control back in your life. And this is what I really appreciate about this study, in particular. 

Bret: 
Yeah, I really like that perspective about giving the patient, the individual control and how you can do that with a dietary intervention. I think that’s so powerful, and you talked about the protocol.

So, you recently published the paper that laid out your protocol of wanting to recruit a hundred individuals for a randomized control trial for 14 weeks of either the ketogenic diet or the Healthy Australian Dietary Recommendations. So, Jaymee, let’s go to you. When you’re talking about enrolling a hundred individuals and 50 eating one diet, 50 eating another diet, how are you as the dietician approaching this about how to help the patients learn what to eat because we know what the dietary study adherence is so crucial?

So, how are you approaching that for the study? 

Jaymee-Leigh: 
Yeah, thank you, Zoltán and Carlo, I guess from my perspective, I was introduced initially to Zoltán through a neurologist. So, I’d had a background in epilepsy, and ketogenic diets in epilepsy. So, I’d had some experience, obviously, implementing the diet in adult population, which was, I guess, back in 2013-14, a bit.

It wasn’t common up in north Queensland. So Matthew’s Friends was where I’d trained to actually do ketogenic diet therapy, which I think is instrumental really in this trial. So yeah, you’re right. There’s a lot of participants. And from that perspective, I think the biggest key takeaways is a lot of support.

So, we provide a lot of support within the trial looking at from a dietary intervention point of view, I’ve started with participants bringing three days worth of their food diary. By the time I see them for their first appointment, I’ve already got in my mind a little bit about their diet history.

I can see how they commonly eat in the community. And that gives me, I guess I’ve been a dietician for 13 years working in acute hospital spaces, including ICU surgical medical, but also within mental health for the last 10 years. I think having that bit of background information about their diet’s been really important because by the time I meet them, I’m able to, I guess people are generally a creature of habit, and you probably know within yourself that you have diet choices that are quite regular.

And so rather than taking the approach of I’m going to change your whole diet like this, and your whole world’s going to change in a moment. It’s about looking at what they already eat and trying to familiarize them with perhaps the change in diet, but making it so that it’s not a huge change straight up.

So, within our protocol, there’s a two week leaning into either diet. So, the Australian Guide to Healthy Eating, I’m sure it’s much most other diets from a government level around the world that there is recommendations. However, we know from dietary surveys that a lot of Australians don’t follow the Australian Guide to Healthy Eating.

And sometimes that’s not because they don’t know about it. Some, a lot of the community do know about what the Australian Guide to Healthy Eating is. They’ll be able to come into clinic and say, yeah, that’s that plate thing. And yes, that’s important, the plate. But they often aren’t so aware of how to put the Australian Guide to Healthy Eating into practice.

So, obviously my job is to, I guess, educate in the first instance of what’s a serve size. So, sometimes there’s a lot of discrepancy about what a serve of carbohydrate is and that’s not just within the general community. Even if you go to the medical community, including even endocrinologists and say, how many carbs is in this large banana, a Cavendish banana, you’ll get five different answers.

And so, I think taking it back to really simple steps of educating what a serve size is, whether that be dairy or whether that be carbs or whether that be fat serves, we’ve done that as part of the Australian Guide to Healthy Eating intervention group.

And then, obviously, the ketogenic diet is a 2 is to 1 ratio. For the most part, that I think has been the most successful way of keeping patients, for such a long period of time, the lead in time’s two weeks, but it’s 12 weeks on the diet. So, three months isn’t a short time.

It’s definitely time to build a habit, is what I say. 

Bret: 
But I think, so just say, sorry to interrupt you real quick, you said 2 to 1, meaning 2 grams of fat for every 1 gram of carbohydrates plus protein 

Jaymee-Leigh: 
That’s right. 

Bret: 
Okay. 

Jaymee-Leigh: 
So, that’s exactly right. So, 2 grams of fat to 1 gram of mixed protein and carbs.

So, it’s certainly not a, people often come in to the diet with the understanding of I’m going to be able to eat as much protein as I can through the whole diet. And so it does take a bit of education around actually providing their individual requirements. And I think Carlo and Zoltán have both mentioned that a lot of these participants, yes, they may have schizophrenia or bipolar, but they’ve also come with a lot of other chronic disease alongside of that, which is not uncommon within working in mental health.

Again, some of these medications make people hungry. They’ve got a lot of nocturnal eating, so weight gain is often. No one comes to clinic to say, oh, I went on this medication and I put on 20 kilos in 12 months. I was definitely expecting that, but my mental health’s improved.

They often say to me like, oh my gosh, I’ve put on 20 kilos. I don’t even feel like myself anymore. So, we’ve certainly taken that into consideration, too, that some of their health concerns, like type 2 diabetes, cardiovascular disease, amongst a whole host of other issues, a lot of skin concerns with aprons when people have morbidly obese. So, all of that factors into when I meet an individual, and I guess the biggest part of this trial has been individualized care. It’s knowing that everybody’s a bit different. Everyone’s life’s a bit different.

Some of our participants have three kids. Some are single moms. Some have support workers, and they’re not functioning independently in the community. And we are not using meal delivery services because, I think from my perspective, one of the biggest things has been I want these people to be able to manage this diet as a lifestyle change as a treatment intervention lifelong, not just for a period of time.

That perhaps they wouldn’t be able to manage without my support, and the whole team’s support really. I think it’s been about giving them the support they need in the most crucial times, but also letting them have some independency with that and improving their self-efficacy to show them that they can do it.

And I’ve definitely seen that. 

Bret: 
Yeah, Really good point about making sure they can do it themselves in the community and their life because that’s a big part of this. People can’t afford to have meal delivery their whole life. But if you can show that you can teach them how to do it and they can stick with it, and then you can really see the real world kind of benefit. I think that’s important.

Yeah, yeah. Zoltán, you wanna add to that? 

ZoltÃn: 
If I may add just something to Jaymee-Leigh’s comments. I think what Jaymee-Leigh said about the support our participants are getting is very important from the point of view of the scientific integrity of this randomized controlled clinical trial.

Because it is not just only our ketogenic diet arm that is receiving that kind of support. It is important to emphasize that the Australian Guide to Health Eating is also a deviation of their usual diet. So, the control is not diet as usual. I think that’s very important. It’s important for two reasons.

One, they are getting exactly the same kind of support. Our ketogenic participants are getting, on one hand, and expectations are terribly effective and powerful in clinical trials. Patients come in, participants come in with great expectations, they will get better. Everything works for the first time.

So that’s not the question. The question is it working better than another intervention, which requires a similar amount of support? Similar amount of looking after? Similar amount of checking on them on a daily basis? Whether they are measure their ketones, their blood glucose so on one hand? But on the other hand, we expect our control arm to improve metabolically as well because they are eating less. They are losing weight.

Their glucose metabolism will improve. Their insulin glucose balance will improve considerably, and that is important because this design will allow us to tease out the role of these different factors in the potential efficacy of ketogenic diet. Because the main difference between our two groups will be whether they are in ketosis or not.

So, our ketogenic diet group, they are in ketosis. Our Australian Guide Healthy Eating Group are going to be losing weight. They’re going to metabolically improve, but they are never going to be in ketosis. 

Bret: 
Yeah, such an important point about the design of the study and how important that is. Because anybody can improve their health practically if they’re eating the way the majority of the people in this world eat.

And that’s a sad statement, but very true. So important to have two active intervention arms. So really good. And then Carlo, let’s go back to you. So, then when we talk about outcomes, what are some of the main factors? Or what are some of the main measures you’re looking at in this study to see if and how people improve?

Carlo: 
So, we are measuring a set of psychiatric measures that are international recognized that being able to pick up the difference between people who are doing well on both disorders.

So, we have a set of psychiatric test, including the positive and negative symptoms scale, and the young mania rating scale by MRS. And, of course, the Back Depression Inventory, BDI, and several other outcome measures including the WHO, the World Health Organization’s disability scale, which is set up to measure the quality of life people have.

So, we do that by combination of a psychiatric interview, which is going to be performed at baseline when we first meet the patients. We repeat the same measurements at midpoint, and then we do that once again at the end of it. We have a cognitive battery as well called CANTAB and that is pretty much the gold standard in measuring brain functioning.

And it measures a number of cognitive abilities and particularly focusing on attention and frontotemporal functioning of, so executive functions of the frontal area of the brain. And it’s quite a sensitive test as well. That’s what is good about the CANTAB and able to detect even smaller changes in brain speed, in a way, synaptic speed processing. So, we do that as well in the beginning and at the end.

I would like to add as well that the measurements we’re doing are also daily. So we ask the participants to check their own, to give us a rating about their own, how well they’re doing every single day. And it’s simple digit, but very similar to the visual analog scale where we’re asking people to just put a line at where the field they are at. 

And I think that measurement is extremely important from a clinical point of view, a subjective rating of how energetic they’re feeling because we believe that the energy levels are going to be very important.

We also asking them to give us a general sense of what the experience is like so that qualitative data that we are going to measure that’s very difficult to define in quantitative studies like randomized clinical controlled trials where it’s just dry numbers. But what do dry numbers, mean? And I think it’s important to add that what Zoltán, just adding on what Zoltán was saying before, the scientific integrity, we really did everything we could to make sure that the study was scientifically sound but also clinically sound.

So, I didn’t want to run a trial that was fake participant trial that would give us fake results. Gold standard perfect patient, that doesn’t really exist. So, I want real patients that I see every day in my clinical practice, who have bipolar and schizophrenia and severe mental disorders, and give them a chance to do better.

So, I want people who are ,of course, stable enough in order to be able to participate in a clinical trial and be able to consent legally and also stable enough to be able to change their diet around or have someone who helps them do that. So, I want that participant that is my average patient in the community.

And we wanted someone who still had symptoms. So still suffers, still has issues with their mental health. And therefore, our exclusion criteria is really stripped to the bare minimum, so that we make sure that it’s a safe practice. And, of course, people are safely taking a diet and will be able to raise their hands if something is going wrong, which is why I stress the ketogenic diet is a medically supervised diet.

And, of course, it’s a dietician-led diet. So, I want participants to follow our dietician’s advice and Jaymee-Leigh has spent hours and hours on end with each participant in doing exactly that. But also if there is any issue, even the smallest issue, I’m called, either me or one of the other two psychiatrists, Omer or Shaileigh, being called to give an opinion about is there a medically relevant issue that is happening.

Yeah, and we have had situations where we picked up metabolic issues that have not been picked up in the community because they are very subtle. And we had to phrase that with their participants’ general practitioner, and make sure that not they’re looked after. Of course, completely independently from the diet.

That was coincidental situation was happening because of the patient’s circumstances. 

Bret: 
Yeah, but it’s so important to have that safety measure in place. So, really good to hear that. it’s an active trial with active changes. Yeah, and so the trial has been ongoing. Yeah, and Zoltán, yeah tell us. 

ZoltÃn: 
Yeah, so in terms of the outcome measures, I would like to add a couple of more things. So, the primary aim of this study is to investigate the efficacy of the ketogenic metabolic therapy. But we are also interested in potential mechanisms so through which mechanisms, ketogenic, dietetic, or therapeutic effects.

So in order to approach this question, we are collecting a number of samples to analyze actually quite a large number of biomarkers, and that includes a complete metabolic blood profiling, glucose, insulin, lipids and all the usual things. But beyond that, we are also interested in the activity of the autonomic nervous system heart rate, heart rate variability, skin temperature.

Things like that are related to the overall stress response of the body. So, our participants are wearing at the beginning for one week and at the end of the trial for another week two wearable devices. EmbracePlus, which is a watch-like device and the Oura Ring to follow these autonomic nervous system activity, measures during the day and also during night to get some information about their sleep health, which is likely to be affected.

We know it is affected by the underlying disease condition and it’s likely to be affected by them by the treatment. And, of course, we are talking about a diet, and diet influences the gut microbiome. So, we decided to collect fecal samples from the very beginning. We were very lucky to secure separate funding from the foundation in here in Australia, which will allow us to profile the gut microbiome of our participants prior to and following the dietary intervention.

I think this is really very important. And another important aspect is the network. We are part of other labs working on ketogenic diet-related clinical trials in psychiatry through the Baszucki Foundation. And through that network, we have not only been able to design the study, but also we will have collaborators to have some of the biomarkers measures, which we can’t do in our lab.

I think, in short, what we are interested in figuring out potential mechanisms, and through the number of measures we are taking, I think we can take the first step into that direction. 

Bret: 
Yeah, such an ambitious study. When you think about all the psychiatric outcomes, the metabolic outcomes, the microbiome, the metabolomics, the qualitative in addition to the quantitative, like really getting at the clinical and the mechanistic effects in one trial.

Really ambitious and it’s a trial that’s already underway. So, you’re enrolling now, but it is underway. So, Jaymee-Leigh, tell us a little bit or what you can about the experience so far, what you’ve seen with the participants. 

Jaymee-Leigh: 
Yeah, so just a little bit from ZoltÃn as well with what he just said about microbiome, there’s some participants that do come with, I think there’s a lot of information out there around gut microbiome, and participants are either reading that or they’re on social media and they’re seeing that. And so they’re always just, there’s always one person that seems to come up with, oh, the ketogenic diet.

I won’t be able to, my gut health will be poor. And I think that’s something that we’re trying to like in practice, I guess, implement that’s not always the way. Bleu cheese is fermented food product, and that’s something that we use in the diet. Olives, again, they’re a fermented food item.

There’s ways within a ketogenic diet that we implement people’s food beliefs within there as well. I think that’s just an important point when we are looking at the individual as well and what food beliefs they come with. We work with the individual. What I’ve seen from our participants has been quite amazing.

it’s hard not to be very proud of them. And like what Carlos said, it’s something that we see in our everyday practice, in the hospital settings. People that are really struggling with their mental health, and I guess even my own expectation of how well these people would go. And sometimes my concern in clinic of am I going to be able to assist this person and support them to get onto the diet, particularly from the ketogenic arm?

And the Australian Guide to Healthy Eating, to tell you the truth, they’ve done exceptionally well. We’ve had participants return to work that haven’t worked in many years. We’ve had participants that haven’t had a job, that now have a job and have gone from a couple of days a week to now full-time.

It’s quite humbling when participants come into clinic and say, i’ve not been able to have a conversation with someone at the coffee shop without them not considering my mental illness and being frightened of me. That’s the words they use.

People are frightened of me. Since being on the diet, that I can have conversations and I know that they’re not just looking at my mental illness or speaking with my mental illness, is what participants report, which is amazing. And I think even contact with children. We’ve had some participants that have had very limited contact with their children for various reasons.

And stabilizing them has meant that they’ve had more contact with their children, again, which is quite amazing. So, I think, they’ve done so well. We are proud of them. I think every week, I see them, I talk to them, I talk to them face-to-face or over the phone with whatever works.

Because some of them are now working, text messages. Like we’ve got various forms of communication emails, and it’s not uncommon to have, participants just say how well they feel. And just the standard stuff like yes, higher energy levels, and clarity like in their thought processes.

But just me seeing them over that period of time from the first week in the clinic to the last week in the clinic, and seeing them just evolve is amazing. 

Bret: 
I love that perspective. There’s the data that you’re measuring and then there’s just that human component that you just get to experience by being around them, and that’s such a wonderful perspective.

Carlo or ZoltÃn, do you wanna chime in about what you’ve seen so far? 

Carlo: 
I’ll happily can say, I could say a lot about it, but I’m mindful. Of course, we are still running the trial, but I can certainly support Jaymee’s perspective there. It’s been humbling. I’ve, again, of course, all the anxiety that was in the beginning. So, are we able to do that in the first place?

Will participants be able to follow a diet and stick with it? And I think it just reflects the bias that we as clinicians sometimes have. Now, people with mental disorders are highly functioning individuals who would like to have a perfectly normal life.

That’s their ambition and really find it difficult. So, the intervention we are offering is simply allowing them to have a normal life, to get their lives back. And to be fair on them, they are putting so much effort into it, coming religiously to the appointments, following everything.

So, we have additional add-ons as well to our trial, including measuring their autonomic arousal and the movements and the sleep via wearable devices. In particular, two devices called, one is called Oura, and one is called Embrace. And that really tallies up to physiological functioning of the body.

And we expect, oh, people will not be keen on wearing them because this and that, and it’s a bit of a nuisance. Actually, we have almost everyone taking them on, wanting to contribute with their data and helping the trial run, but also being curious about how the body reacts to the diet.

So, we have these significant participations from the from the participants, coming back religiously, coming to the dietician appointments, letting us know of any issues. And sitting in a couple of hours with me or with my colleagues to do the psychiatric assessment and half an hour on the iPad for the CANTAB.

All of that, doing it religiously well. So, we are completely humbled. And I have also seen in the patients who have completed, participants who have completed, the arm, I certainly, and I don’t know which arm they are on, I’m kept blind as much as possible. And I’ve seen them brightening up by the end of the three months, being more interactive, being more aware of the surroundings, and being simply happier about themselves and more satisfied with themselves.

Some have lost weight as well, which certainly helps in their, simply in their confidence and quality of life. And as Jaymee has said, people who have started working. I come on the final interview and say what’s happened in the last couple of weeks? And it’s, you know what? I found a job in this place or the other, and I’ve always been looking to have this opportunity, and I never really felt confident enough to do that. But now, I did and I just went. Or simply know I’m able to not do my home chores better and look after my kids better or whatever it is that they are, it’s important to them.

So, this is what we are really proud of. We wanted to show that a dietary intervention in people with severe mental disorder is not only just effective, which is what we are hoping, of course, to show, but possible. It is possible. We can do that. We can give people a hope that the life can improve without necessarily telling them to take medication exclusively.

Although, of course, medication is extremely important, too. I’m not saying the opposite. 

Bret: 
If someone wants to enroll and take part in the study, where can we direct them to go? And do they have to be local in Australia, too? 

ZoltÃn: 
They have to be local. They have to be local 

to 

ZoltÃn: 
Townsville and the area.

Believe it or not, Bret, we have participants who relocated to Townsville for being part of the trial. 

Bret: 
That’s amazing. That shows just the desire for something new, something different, something better. 

ZoltÃn: 
There is a tremendous, there is a tremendous desire for sure. 

Jaymee-Leigh: 
And for people that might not know Australia.

People moving, like when we say they’re moving to Townsville, we are talking about a 15 to 18 hour drive from Brisbane to Townsville. That’s how far they’re moving. Yeah, that’s a long way. 

Bret: 
Yeah, that certainly is. 

Carlo: 
It’s a very long way. And to be fair, for me, with European eyes, coming to Australia, Townsville is a magnificent place to be.

So, all come. Anyone who’s listening to relocate to Townsville. It’s a tropical area. You got the coral reef in front of you. It’s absolutely gorgeous. So, it’s not the wrong choice to do that. Maybe we should account for the kind of tropical beauty effect of people being in the trial for? Only kidding, of course.

But certainly this is humbling. Again, we had two people who have actually made distance to come in from Australia. So ,yes, they have to be local. They have to be part of the Townsville Hospital catchment area as part of our ethics. We do have a website called North Queensland Data Intervention trial (dot) com (dot) au. So that’s www.nqdit.com.au.

And they can just simply click on the link there, and register the details, if you are from Townsville local. Or simply just Google our names, and we come up. That’s the other way to do it. 

ZoltÃn: 
The whole reason of getting into the trouble of running a randomized control clinical trial, which is a huge amount of work, and it is based on the contribution of at least a dozen people on the ground on a daily basis, let alone the funding we are receiving from Baszucki Foundation.

So, the reason to do a randomized control trial like that is actually two-fold. On one hand, we want to provide good standard scientific evidence to help convincing the scientific and the medical community that this intervention safe and effective. So this is one.

The other one is actually to make the life of our participants better, and that’s probably the priority for all of us. You can hear Jaymee and Carlo talking about their daily experience, and this is just amazing to be able to make a difference. As biomedical researcher, I’m privileged to be part of something like that. It does not happen very often in the career of a scientist. 

Bret: 
I think that’s a wonderful way to wrap it up. And I want to thank all three of you for joining me and for all your work. You’re very ambitious work and doing this study, and I am very excited to have you all on again the future where we can talk about the publication that’s going to come out of this because.

Just the data you’re collecting, you’re going to learn so much from both a clinical and mechanistic standpoint. And this is going to be an outstanding study, regardless of what it shows. We’re going to learn so much. So, thank you all. I really appreciate you taking the time. 

Jaymee-Leigh: 
Thanks. 

Carlo: 
Thank you, Brett.

ZoltÃn: 
Thank you for having us. 

Bret: 
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