How Omega-3s Affect Learning & Behavior

OmegaMatters: Episode 28

Hosts: Drs. Bill Harris & Kristina Harris Jackson

Guest: Dr. Alex Richardson, Founder & Director of the Food and Behavior Research Lab

Background and Key Takeaways:

For 30 years, Dr. Alex Richardson has been based at Oxford University and the Department of Physiology, Anatomy and Genetics. And for the last 20 years, she’s been the founding founder, director of the UK-based charity Food and Behavior Research, known as Fab or Fab Research Lab. She is in the top 3% of academic researchers worldwide based on the impact of her over 90 publications. With her more prominent work coming from her studies of how omega three fatty acids affect behavior, learning and mood, particularly in children.   For more information on OmegaMatters, visit: https://omegaquant.com/omegamatters-broadcasts/

 

SHOW TRANSCRIPT:

Dr. Kristina Harris Jackson: Welcome to OmegaMatters, where we talk all things omegas. I’m Kristina Jackson and this is Bill, and today we’re talking with Dr. Alex Richardson about omega threes and learning, which is very interesting and important and tricky. For 30 years, Alex has been based at Oxford University and the Department of Physiology, Anatomy and Genetics. And for the last 20 years, she’s been the founding founder, director of the UK based charity Food and Behavior Research, known as Fab or Fab Research Lab. She is in the top 3% of academic researchers worldwide based on the impact of her over 90 publications. With her more prominent work coming from her studies of how omega three fatty acids affect behavior, learning and mood, particularly in children. Thank you so much for joining us today.

Dr. Alex Richardson: Well, thank you for inviting me, because I love talking about fatty acids and why it is that about the most important thing, getting the facts right is basically going to become probably the title for our podcast because I think you’ll…

Dr. Kristina Harris Jackson: Yeah. Yes, that’s a good one. Yeah. So can you give us just a quick background and how you got to study this area and how where you are today and the research.

Dr. Alex Richardson: I’ll try to keep it quick and my initial background. My first job after my first degree was teaching children and I’d always been interested in individual differences. What is it that makes people, you know, behave and think and feel in different ways?

Dr. Alex Richardson: And I think neurodiversity is the name. And yes, of course we’re all different for biological psychological issues. But it was while teaching when I saw first-hand how some of the brightest, the most creative, the most hard working, but they were getting labels like lazy, careless and stupid, the education system was just not giving a chance to my children.

Dr. Alex Richardson: I was teaching who could have met needed criteria for dyslexia, ADHD, dyspraxia, etc.. So I thought, naively maybe, that I could do something about this or find out more. So that led me into research. It was a full retrain for the Ph.D. because my goodness, neurophysiology and psychology. I had supervisors in both of those Oxford departments, but also psycho physics because vision and visual processing and then later auditory sensory processing was actually the thing we were looking at.

Dr. Alex Richardson: Vision, of course, is very, very critical to learning to read. So there was a study with six foot high letters that were in Hebrew or English, and there was no difference between groups. So vision has nothing to do with dyslexia. Was the mainstream and group opposite. Professor Jill Stein. Amazing man who I still study now but still work with my Ph.D. then dyslexia was the central focus.

Dr. Alex Richardson: But the other thing I wish more people appreciated. There is no such thing as dyslexia in the sense that yeah, that individual differences in all kinds of domains and dimensions, but dyslexia, ADHD, dyspraxia, autism spectrum and even across my Ph.D. did finish up making some links into other domains that are more regarded as mental health rather than developmental.

Dr. Alex Richardson: But it’s all about the brain, and the nutrition didn’t come in until later. I was postdoc and I came up all in order to build a visual system in particular, but a brain and a nervous system work. I want you to know you need omega three fatty acids. You need omega six. You know, Michael Crawford, who’s just done a brilliant webinar so far, research, I know he’s done one for you and he’s just written another book.

Dr. Alex Richardson: My goodness me. But yeah, he warned 50 years ago that more than if we don’t do something, he said in 1972 about the fats in all brain disorders there will be next because you don’t have these fats in the diet. So yeah, as I began to study that, good gracious, something as simple as diet might be an intervention that led me to do what became the very first randomized, double blind placebo controlled trials that was try giving fish oils.

Dr. Alex Richardson: Now, my early studies, there was a dash of evening primrose in there. So some of the omega six as well. But yeah, it was an obvious thing to do with my background what I was interested in. So those were my early trials. The first was published in 2002. Now it’s become known as an ADHD study and goes into network analysis of those.

Dr. Alex Richardson: And fair enough. But it was actually that was the outcome measure I chose because as I did the background research that you do, don’t reinvent the wheel. The people done in this field, the only real background is studies of fatty acids, omega three and it make a six what to do with ADHD. That means very good blood studies that had come out of Purdue University that even been the hyperactive children’s support group in the UK were onto this in 1981.

Dr. Alex Richardson: What essential fatty acid deficiency explain in some of the features and traits and symptoms. Now again, these labels and are these diseases all disorders or are they just. Yeah, when the traits and features become symptoms of me, the background then was to the do studies was these early trials of mine because the first study was actually dyslexic children.

Dr. Alex Richardson: But when it’s a short time period you need to be careful. You expect that something that’s being altered has to be explicitly taught like reading. Yeah, I just thought, okay, let’s take those who are above average. They’ve got room to improve. It must be at least one standard deviation above the mean on ADHD tiny pilot study.

Dr. Alex Richardson: It got a lot of media attention, but that paved the way for the Oxford Durham study published in 2005. Now, this time, you do know that if you want to publish in the journal Pediatrics, what’s the diagnosis? What’s the disease this time? Developmental Coordination disorder. Dyspraxia. Now I have my reasons. For which of them shall I go for?

Dr. Alex Richardson: If we went into those, we would be here till 6:00. So that’s not with really vision. Very briefly, I knew that if you meet criteria for that diagnostic label for almost all of the children and adults with dyspraxia as it’s commonly known or DCD.

Dr. Alex Richardson: That’s the overlap actually into dyslexia as well. Whereas hyperactivity, impulsivity are not a particularly strong overlap with those, but yet we therefore were the ones, those who put the diagnosis on these children who took part in the Oxford Durham study. They’ve just been underachieving children in mainstream primary schools. Although we had a good team on the ground who knew the staff.

Dr. Alex Richardson: If we’re going to be screening across all the schools in County Durham and finding then it was our team who did the full IQ tests, the page standardized, you know, movement coordination measures for the DC databases, but we also for our outcomes here were ADHD symptoms and reading and spelling and the motor coordination and measures. But those were not particularly well known or statistically or very good anyway.

Dr. Alex Richardson: So we did find very impressive results in that trial. What was the dose? I mean, it was an intervention. Well the dose there. Yeah, good question. Good. And it’s lovely to be with the folk who actually get on. It’s all omega-3. It was again, as with my first study, 80% fish oil, 20%. Evening, primrose oil, because for at least some children and adults, the does seem to be a benefit in giving some of these omega-6 fats, which do tend, of course, and we’re all guilty of it to have been all demonized but yeah allowed from evening primrose convert instantly to DGLA and that’s a source of regulatory substances.

Dr. Alex Richardson: The problem with very early studies in ADHD is there are a lot of the physical signs of what was called essential fatty acid deficiency, so particularly dry rough skin and hair you know tendencies to dandruff etc. So first study, it was a high DHA official. But the dose that you asked about, Bill, in both the tiny pilot study and the Oxford Durham, we were looking at no more than about 600 and little less of the long chain omega-3 needed from fish oils.

Dr. Alex Richardson: But in the first pilot study it was DHA-rich, whereas for the Oxford Durham study, it was an EPA-rich formulation on purpose. Yes, actually, because another thing that I knew from my thesis were I told you I’d branched into linking, which was a bit dangerous. If you want to help people with a label like dyslexia, I’ve been branching into and finding links across the schizophrenia spectrum and some of the personality traits.

Dr. Alex Richardson: We’re talking individual differences here and certainly anyway, the whole thing about schizophrenia and depression with colleagues in London, as part of my early postdoc work, I still have the Oxford base, but my short term paid job now is in London. Good. I’m working in a psychiatry unit in a psychology unit, in the psychology department, and we actually published in the late nineties the first ever case study of omega-3.

Dr. Alex Richardson: And this was pure EPA for schizophrenia, followed by the first case study. Again, single case, but very intense measures showing that a high dose of, again, pure EPA could alleviate clinical depression and that was a seriously treatment resistant. He was 21 when his father brought him to us. He’d been depressed since he was 14. He tried absolutely everything.

Dr. Alex Richardson: So this is it. I’m although I’m best known of course for my child behavioral learning and Colin’s book they wanted the title of “They are what you feed them” but this has helped. Before he ever published some of his studies. Malcolm Pete was the psychiatrist who did the pioneering first clinical trials of omega-3 for both schizophrenia and depression.

Dr. Alex Richardson: So we’re well aware, but you can’t study everything and then doing that and Joe Hegel of the course was getting going fine. But I knew as well how often are individuals who’ve got the traits, features, characteristics, if not symptoms of dyslexia, ADHD, dyspraxia, how well you are going to find it a bit stressful. You’re failing. Nobody else finds this easy.

Dr. Alex Richardson: You’re at school and whether it’s, you know, your thoughts on the sports field or whether it’s you can’t read and write, nobody else can, or that your behavior keeps getting you into trouble or you can’t focus what you’re quickly going to find. Well, of course, anxiety, stress, possibly what it then be called depression. But this is it. Back in those days, diagnoses like clinical depression, you know, it was far less likely that that would be, you know, given to a child yet started really to go mainstream.

Dr. Alex Richardson: And what Michael Crawford warned about in the early seventies, my goodness, hadn’t yet taken hold gets me real evidence we have got now about how important the right fats are to the brain of a system and its development in the first place. But anyway, the Oxford Durham study then. Yeah, I was well aware that some of the mood, anxiety, stress, nobody learns well if they’re stressed, anxious or if they’re not sleeping.

Dr. Alex Richardson: I wanted, but I didn’t manage to get a sleep measure into the Oxford Durham study. We were doing quite enough. So yeah, I did lean towards. I was kind of looking for and somebody had come up with an absolute I’m a clone of the first ever supplement that was, you know, in this space and fun. Let’s choose that then for the Oxford term study, no user exam, actually.

Dr. Alex Richardson: No it wasn’t and called I was don’t want to ever give commercial plugs and this and that because they didn’t fund the study they also, oh my ex collaborator on that. Oh no she ran off with the company and was all over the media from literally it was the first week of recruitment. I was often that was, you know, whether it was a schizophrenia.

Dr. Alex Richardson: Your meeting, I came back to find, Oh my God, we haven’t even become data collection. But this miracle pill study is all over the newspapers. So really for the 2 to 3 years that it took and we should have had that study published soon, 2005. But the media explosion was not that I’d rather not than what? We don’t need to go there.

Dr. Kristina Harris Jackson: That’s fascinating.

Dr. Alex Richardson: Just so supplements are available. But yeah, it had majority EPA and DHA that details the it wasn’t absolutely in the papers but yeah this is it again my early studies small charities you know were the source of the funding for and anyway the results we got and I wish somebody else no one has done a replication study trying to look at this population. We have given them the B, C, D, developmental coordination disorder diagnosis. They fully met that one third of them would also have met criteria for dyslexia where assessing their reading IQ look and for ADHD, it was again around one third. They were certainly in the clinical range, two standard deviations above the mean on ADHD symptoms assessed in this case by teachers.

Dr. Alex Richardson: Parents were harder to find, harder to round up. You couldn’t get all the data out of them. But yeah, these teachers were very engaged. They did fantastic data collection and so on. Now results. We did find a replication of the visual with a little evening primrose improves ADHD type symptoms significantly. It also improved reading and spelling. Now I think even to this day I know of no intervention, educational or otherwise, that has ever been tested out in a randomized controlled trial where you can boost children’s spelling progress.

Dr. Alex Richardson: As for the reading, the active group, they made nine months gain in reading age in the three months of the parallel group part of the study. But really with both of my early charity funded little pilot trials, the design there actually was a one way treatment crossover after the main three months of treatment in parallel groups.

Dr. Alex Richardson: Because what you’re doing there is you are allowing the very same children who were on placebo to now receive the active treatment and follow up, because that way each child is sort of being their own control. But no, they’re not. You can’t step into the same river twice. Other things have changed. This is a follow on.

Dr. Alex Richardson: And therefore statistically for the purists, nobody’s interested in your one way cross. So the data I was interested in because it was just stunning. There was the crossover effect. Everything that you’d seen the active group improved dramatically; let me say there is an anxiety subscale in the commas, long form ADHD rating scales used in all the ADHD treatment trials of medications.

Dr. Alex Richardson: And so if you use the long form yet the anxiety that was very striking in both my early studies, it also matched what you were seeing clinically and every day, as you suggest to some of you and all the support groups. I had a background in teaching. You know, I knew the front here, I knew I knew the population.

Dr. Alex Richardson: Yeah. Which I will say I think this matters hugely. If you’re going to get good research trials, it isn’t all just about your box ticking aspects of the design. But what also matters is are you asking the right questions? Have you selected the population you know that’s most likely to respond unless of course, you’re wishing to do one of those negative studies where all you want to do is show that it doesn’t work, which of course I think we know there’s a lot of that goes on.

Dr. Alex Richardson: And I do feel like some of the areas that some of the people who love doing that. So the Oxford Durham study, it had been for 2 to 3 years all over the newspapers anyway, it had also led to I hope it’s faded now, but no question the talk about premature and over the top, the miracle pill stories that had been all over all mainstream media.

Dr. Alex Richardson: We called it the Oxford study, because there had been years of, oh, another Oxford Durham trial being reported as a double page spread in the tabloid press. I got to know actually one of the health editors at the BBC quite well, because a large part of my job was, Oh no, my mobile has gone off again.

Dr. Alex Richardson: Alex, could you possibly get to the studio and be the scientific voice of reason? And I’ll be asking, why have they sent a BBC team to another study with no placebo group, no nothing, and reporting it like a miracle pill story? Because yeah, there was a background to that which I think would have driven a lot of people away from research and let’s go back and do something else instead.

Dr. Alex Richardson: The next study following on which you’ve chosen, what happens? We might discuss it in our chat. Yeah, because the EU, the Oxford Durham study, as I say, until we came along and recruited them into our study, these were underachieving children in mainstream primary schools whose potential were all in the normal range for general ability or it’s called IQ.

Dr. Alex Richardson: It’s part of the diagnosis of DCD, but they were on average, Oh my goodness, two years behind in their reading, three years behind in their spelling. Now this is going to completely alternate, put it that way. Your chances of education now occupying their lifetime. So it did seem and not least as well the media cover the Durham on their own we’re doing an awful lot of advertisements for supplements still to me you know oh we are doing trials which no you’re not there’s no placebo group, but we’re going to give magic capsules to the whole of, you know, all the kids in County Durham county and Yeah, yeah.

Dr. Alex Richardson: But only a mainstream school population and leaving aside not interested in school in the UK certainly most of the education professionals and I totally understand why they’ve never been fond of medicalizing disease diagnoses like dyslexia and I understand why they tend to prefer to refer to them as special needs special ed consultants.

Dr. Alex Richardson: Or you know what? Because each child is different. Quite honestly, all these populations are very, very heterogeneous. But with the Dunlop study, with all okay, we’ve seen what we’ve got from Oxford, Durham, let’s see whether and this was a company funded trial. So and it was Martek Bioscience who approached us, actually Norm Salem who you know well, is just one of the absolute good gracious mentor.

Dr. Alex Richardson: He had come from Martek and he approached me and said, Hey, do you think, you know, you might be able to do an Oxford Durham study in healthy, normal children? I kind of laughed and said, Well, yes, no, because of course the Oxford Durham kids were healthy, normal children.

Dr. Alex Richardson: And what’s more, the Education Authority, who were a very active collaborative this was fabulous. They wanted to help. They opened up their data sets and no question that schools and they had at the time of their loved one, they had a very good largely a lot of them were part time or what have you, but they had a very good special educational needs service.

Dr. Alex Richardson: They invaluable in acting as ambassadors for the study. They knew the schools, they knew the teachers. And whenever you’re doing a study of this kind, of course you’re going to disrupt the school. If you’re pitching up with a team, children in the classroom, where can we tackle paper and pencil testing.

Dr. Alex Richardson: But yeah, so that was how that one came about and its design. We couldn’t afford the one-way treatment crossover so it was parallel groups. I did decide though let’s make it 6 weeks if you’re going to expect that on a measure like reading a bit ambitious.

Dr. Alex Richardson: But yeah, a six week period parallel groups 600 milligrams a day of an algal source DHA only. But of course, as you will know, there’s an awful lot of other fatty acids for was in the supplement and a little but yeah it was multis, algal DHA and off we go with the Dunlop study outcome measures the primary outcomes very much what had shown good in the Oxford Durham study.

Dr. Alex Richardson: We are going to look at ADHD type symptoms in this population, but we’re going to focus on the reading and focus on the lowest fifth of all readers in a mainstream school population to see whether we can help them with an outcome that is so important to their education or occupational outcomes. But yeah, the ADHD measures, the reading and also I put in as a primary outcome, something which have been a secondary and what isn’t actually therefore reported in the Oxford Durham.

Dr. Alex Richardson: What we’d seen there actually was significant improvements very in auditory working memory, holding in mind a string of numbers. It’s called digit span. Now this again, it’s a hallmark of dyslexia. It’s part of the diagnostic unevenness in the cognitive profile. It’s also part of ADHD, of the ADHD. Can you, for example, you know, if someone reads you out of phone number, how many of those digit sticking monitoring?

Dr. Alex Richardson: So that is a primary measure in Dunlap because not one. It doesn’t require, you know, being explicitly taught. It is a measure that’s tapping into a mixture, if you like, of all the sensory and cognitive processing. So, yeah, we had reading, working memory, those were the cognitive measures. We had the very same long form Connor’s ADHD rating scales, but this time we have both parent and teacher measures and we got very, very good.

Dr. Alex Richardson: Our team again, very experienced, brilliant collaboration from the local authority and that people so again, much like Oxford Durham, we were able to keep on good compliance, remarkably low dropout rates. And we got some very encouraging results in some areas from that Dollar one study. The irony was before we even began recruitment, the county Council, they opened up their own database to all so that we can absolutely look at all of the measures they collected.

Dr. Alex Richardson: We could then plan and target. Okay, how many schools because again, how many visits, how many miles are going to live in a parking lots that we were able to do all that and we could see instantly all we’re going to be up against it to meet our target. If we only focus on the lowest fifth of readers, we could see that before first randomization.

Dr. Alex Richardson: So we again registered protocol in advance, etc. We made an amendment therefore to relax that and make it the lowest the two readers. Now, when we saw results we wished we hadn’t because but reading the wasn’t an overall effect in the sample as a whole of the DHA versus placebo. But there was a significant effect in the poorest fifth of readers, in other words, are the ones to begin with.

Dr. Alex Richardson: And you could meet your numbers in a statistical power as well for the working memory now. Yeah. The other thing was we put pre planned analyzes as we changed, you know, our registered protocol and registered it all pre-planned analyzes for that subgroup. And we also thought well let’s also do a preplanned analysis on the poorest 10% of readers.

Dr. Alex Richardson: Let us look and see if there is more improvement for those whose reading difficulties are more severe. And that was exactly what we found. But yeah, it was only the poorest readers that this helped. But if you put it in reading age terms, this was quite striking. It was a 50% gain in reading each versus placebo for the very poorest 10% of all readers.

Dr. Alex Richardson: I think it was for the bottom 50 readers, but it didn’t do anything for the rest. Now, for me, the really crucial finding was the ADHD measures because yeah, okay, working memory, nothing was statistically significant, but there were kind of similar suggestions or trends that in the very poorest scoring at baseline, the lowest 10% below 20% of readers.

Dr. Alex Richardson: But nothing was significant there. And for the ADHD, the parent ratings across the board showed what we’ve found in the pilot study of dyslexic children, the Oxford Durham study of Dyspraxia children. We have now found that in certainly unselected for ADHD, for goodness sake, just in underachieving on reading, children go across mainstream schools. What we’ve got is on both the global measures of ADHD, which are the inattention and the hyperactivity impulsivity.

Dr. Alex Richardson: But also interesting to me, I’ve always been looking at these on all the individual subscales that you also get if you use the wrong form. Yeah, there were the reductions in anxiety, emotional lability. I have little self scale on that and as the Hyperactive Children Support Group had published in 1981, psychosomatic that got called I hope the drop the psycho and just called them somatic but yeah physical symptoms like stomachache headache you know you think yeah across the board now what was note I should also say that there are many schools one that we’ve picked them out for being poor readers that all they were on average about one standard deviation above the mean on most of those ADHD scales which meant they’ve got room to improve. It’s exactly what I chose. It’s a dyslexic school, but it’s a boarding school. They’re not equipped to start teaching reading, you know, it’s these kids who’ve been diagnosed with dyslexia, brought to somewhere where people understand dyslexia, rightly so. There’s improvement in the behavior.

Dr. Alex Richardson: Yeah, that’s disruptive behavior. Better ability to concentrate. Well that’s kind of your starting point for ability to learn is yeah can you focus on you know stay in your seat etc. So I was very pleased really with the goal of the primary findings.

Dr. Alex Richardson: Well sometimes things just happen. Well yeah, we only do pretty small changes. This is a replication study. These are very important. So what we have done was we’d certainly gone back to what have been supposed to be one target population. If we only saw a benefit for reading in the poorest readers, if the readers let us make the inclusion right, we want only the bottom fifth of all readers.

Dr. Alex Richardson: In retrospect, I should have paid more attention to the ADHD, to be sure. But anyway, because that had been across the board, it didn’t matter whether you were the poorest readers or middle incomes or anything. The other thing was statistical power. Now I’m going to be honest about this in the discussion. Okay, we’re all scientists and they were into fatty acids and they loved, you know, what we were seeing. It was just what was wanted. Yeah, very understood. Who knew? And we’ve been led to believe that we would get the budget to be able to do this. So the working memory measure was our actual end target number.

Dr. Alex Richardson: So really you want 700 plus children for this. Martek became part of the ginormous DSM company, an honestly, you’re talking two or three weeks difference. We nearly had the budgets on sales soar. If we go with a properly funded replication study, suddenly we didn’t recall having met a few of you.

Dr. Alex Richardson: Yeah. You’re at a conference and here are some people from DSM, but they were almost less among that company’s background, whereas it was entirely multiple sciences. They, they knew about this. So yeah, with the DSM folks, they had many other things in their portfolio and they know.

Dr. Alex Richardson: So our budget was literally slashed almost in half. That was  all we were going to get. So it was the case that the reading just saw that 20% of the readers that yeah, okay target 400 children. So those are the two changes focus on the very poorest readers and raise your end.

Dr. Alex Richardson: In Dunlop One, we actually we recruited 362 for goodness sake this time, alright, it’s got to be 400 absolute bare minimum. So off we go. Okay, we are now you might remember the economic crash that followed all those bankers deciding that ah rightio, we’re not solvent and down goes everything and the economic crisis that followed.

Dr. Alex Richardson: So it was a very different background context for the schools and for Oxfordshire County Council. They were still all collaborative. They did in fact to save money because they had to. They’d dispensed with almost all of their special needs, you know, the wonderful people who used to help children. And that absolutely helped us to identify which schools.

Dr. Alex Richardson: So that the other thing was because we’d gone for the lowest of the regions, you could meet more schools, you have enough. Oh yeah. They also wouldn’t open up their dataset to us in advance anymore. That was just one of those admin thing changes. So we can’t with the fabulous guy who he delighted to have someone to share his fantastic data with as we go and do our logistics.

Dr. Alex Richardson: No, that’s not allowed either. Another one that was quite critical. No, they’ve decided as well that for, I don’t know, privacy conflict. Oh no, the school secretary won’t actually allow researchers to even have the phone numbers or any contact details for the parents only because somehow that would become one of those. Oh, no, I was. But I would, you know, explain to people and why they might allow their child to do the study or not.

Dr. Alex Richardson: So, yeah, we were up against serious recruitment problems. We had to, in fact, branch out. And not just Oxfordshire this time. Oh no, it is five counties in southern England. That’s a logistical nightmare. Everyone’s got different systems. And whereas we’ve managed with one local area and 74 schools in one sample this time, oh no, you’re in five different counties and about 85 I can’t remember exactly, but you know what I mean.

Dr. Alex Richardson: Not that many schools, but we were so stretched we haven’t got what we used to have. So it has to be said, we weren’t looking at the same population. We’d made one change. Let’s focus on only the poorest readers. But that actually led inadvertently to a lot of other issues. Yeah, and there’s something about how the kids got the supplement versus thohse who didn’t.

Dr. Alex Richardson: Well, my goodness me. Oh crikey. Things were proving tricky in recruitment. We’ve got a brilliant team and they know what they’re doing and trying their best but this is hard. We haven’t got the special needs.

Dr. Alex Richardson: People are not. Yeah, there was an issue with our capsules, the information sheet and you know, Oh no, it’s emerged that for whatever reasons people are capsule coatings which were but you are it colored you know neurotic and they always have because only some sunset yellow one of the additives linked with oh no ADHD blood in people’s minds you’re not going to go through knockouts you’ll come to worse than that we’ve been told so that we could indeed have no worries at all about the gelatin issues, which is going to upset.

Dr. Alex Richardson: We’ve got a vegan friendly algal oil. Could it possibly be that we’ve got. Oh, no, it isn’t even beef gelatin. No, this is not on. So yeah, the whole study was brought to a grinding, screaming halt. The demoralization. I mean, to be honest, I’ll tell you I never got over it. Most of the schools that were trying to work with us and yeah, the Ethics Committee and to decide that.

Dr. Alex Richardson: All right, this having come to light, we must now notify not just every single child that’s about to or in the process of. But look, we can’t undo the past. And might it perhaps upset more to find that we’ve done this to them if this offends their beliefs? Oh, good. Yeah, we have to notify absolutely everyone, everything, and bring to the stage.

Dr. Alex Richardson: Well, for six months on a study that was underfunded anyway. Oh, what now? I know. So it’s rather not actually the first time that I’ve actually, you know, sort of been a public and with relive the trauma all know, it was just horrific. Yeah. I’m still a bit sore about this to be honest because yeah neither DSM nor Oxford University actually.

Dr. Alex Richardson: So any needs at all whatsoever to be any compensation. But what was blatantly excuse me, this is an actual breach of contract issue. It’s not what you described it to us. It’s not what’s in our information sheet. So we’re now having to suspend the whole study for six months. You’ve upset all the relationships, but we just got to carry on and finish the study.

 

Dr. Bill Harris: No, I mean, it’s great to be able to discuss this listeners here. Yeah. What it really takes to do what’s right. It’s very important.

Dr. Alex Richardson: Yes, it is. Let me say this applies to other areas to where really it does in earlier work. And so the genetics of dyslexia broadly, then we’ve got the best research nurse who and this and that great big EU collaboration this and that with 15 different teams and our Oxford group are one of the ones furnishing, you know, families with two dyslexic siblings. Oh well, remember the first two meetings? And I doubt that Janet is out there anyway, but if you are Janet and you ever hear this? Well done, you’re brilliant. Our team nobody else had even got off the ground because to them dyslexia was a strange disease.

Dr. Alex Richardson: And somehow people will just come flocking. But we have no idea where to find them. We’ve got no idea. Do you mean it is just little practical things which seem they know a lot about genetics. You may be the ones who all the big research teams do, but if you don’t have a knowledge of the population, you’re studying… There’s a lot of divided opinions on this. And with regard to, let’s say, oh, systematic reviews of randomized controlled trials, should we allow people who actually know about the condition about fatty acid formula or should we? Oh, no, no, no. It’s only got to be the statistical people in the box tickers and the process rather a believer in excuse me, if you don’t know anything about the population or the formulate an intervention.

Dr. Alex Richardson: This isn’t just about statistical turn the handle type analyses and as you will know, this has plagued the omega-3 field. If you don’t know the long and the short of it and you’re going to put your flax oil and your fish oil all together and say that omega-3 doesn’t work right.

Dr. Alex Richardson: But people do research for different reasons. Then it was so sad as well. It really was. But it became to be honest, our team again just wants to salvage their own research, you know? Right. They were brilliant. They were hard working. Some of children, no question are measures again of socioeconomic status.

Dr. Alex Richardson: We know lots of things affect your reading or whether you align to make any progress in it and so on. They really were just, oh, come on, we didn’t make the 400. We managed. I think again, awesome. Under the circumstances, nothing happened. Six months total time. So up to 376 but guess well absolutely no effect.

Dr. Alex Richardson: Finally we are to replicate previous findings but again fine for some people want to go tick the box. I wouldn’t have left my name on it. Because I wasn’t terribly happy with you know, what I wanted to do was come on now if we perhaps pull the datasets would take it on and we were certainly on a little more explicit, it’s in there.

Dr. Alex Richardson: But things like the ADHD measures, if you have got 50% dropout missing data because the teachers were a little bit stressed by now and often lost their jobs and for goodness sake, we got more on the parents who we’re not allowed to contact. Now, it isn’t that 50% missing data. I don’t think it’s even meaningful to do a last observation carried forward will do all until analysis anyway of intent to treat and publish just, so yeah there were as I say some differences of opinion let’s put it that way amongst the senior researchers involved as to what should you try to do this pressure to publish this and that.

Dr. Alex Richardson: And it is important, of course it is to come along now. You know, you’ve taken up everyone’s time. That’s not right. Well, there you go. It didn’t work. And you know, you still write, right? It’s so hard to explain all the caveats.

Dr. Bill Harris: I mean, you feel obligated to publish. You put your foot in the water, you’re going to do it. But you it when things go south, you still have to report it, but you can’t really communicate that. Why?

Dr. Alex Richardson: My goodness me. Except again, thank you for inviting me to and having chosen yourselves, you know, you’ve got to put anything for us to focus upon now. Got in a whole array of different things but I looked about do want to exactly.

Dr. Bill Harris: But tell us about the sleep. Well, you haven’t got much time.

Dr. Alex Richardson: Exactly. No, this was it. Because of the resource constraints you now know why we can’t even put no sleep measure into Dunlop Two. But yeah, there were two papers from the DOE lab. One study which one of them was published in 2013. It again in full swing. Now this year we have collected more actual blood fatty acid data, you know, than we in the screening stage made sure that if they were willing, we’re going to get bloods from those who are not eligible for the study because what we wanted to do when we did a study that is really the first report on what is the blood omega-3 status of British children of 7 to 9 year old sample. They were representative of the general population. The reading distribution was a little bit left, shifted also because they were recruiting different candidates for the study, but it did not differ significantly from the general population. Now what we found there and know your fatty acid, this is rather shocking that in Dunlop One, albeit we’re using whole blood, we’re using fingerstick you know technology we have to 2.5% omega-3 Index, which was terribly low, lower values than that apart from the US military.

Dr. Alex Richardson: We only brought them up to 3.8%. We got them up to two point something, for goodness sake. Would you therefore on first scientific principles, would you really expect that brain nervous system have got what they need here? No. I know that the optimal is more than 8%, and that’s on the red cell. Of course, it is an excellent tool for. But yeah, this was just great.

Dr. Alex Richardson: And here’s another thing that was not flagged. There was a mixture of poor compliance and flipping it how much would you need to give to get them even about 4% let alone do anything that would approach optimal.

Dr. Alex Richardson: Yeah. It wasn’t just the treatment trial kids – 600 or so children total. Some of those were lost in processing transit. But yeah, what we found was despite the very restricted range, the lack of variance, there were significant associations between blood, DHA and reading and ADHD symptoms and working memory.

Dr. Alex Richardson: We published this another study in 2014 on sleep measures, because since I first got involved with fatty acids, this anecdotal report in our very first trials of children, it also came through from patients, depression, schizophrenia, whatever it was, improvements in sleep. Now gracious me if we think about it, and with every developmental and mental health condition. Sleep was a secondary measure.

Dr. Alex Richardson: But what we had there was both subjective and objective in a subset measures of sleep. In a subset of those Dunlop children, five nights we visit them in their own home, teach them how to use it, which in some of them we had those measures too, as well as the blood fatty acids. So in terms of blood fatty acids and initial sleep problems, yep, those were significantly correlated in terms of treatment.

Dr. Alex Richardson: Now I’m a great believer in if there isn’t any room to improve and you don’t have a problem, then you’re not likely to see an improvement. And so far in the samples whole, we didn’t. But it was striking that more than half of these underachieving kids in mainstream schools have a clinical level sleep problem, according to their scores on age standardized for the UK population.

Dr. Alex Richardson: Parents, you know, fills in questionnaires. Good grief. And in those children who have all had room to improve, they do, at least by report obviously. Problem. Yeah we got a significant treatment effect of DHA alone improves their sleep. When we finally were able to look at the time, when are we going to do the analysis of the objective data?

Dr. Alex Richardson: It was a small subset, so you have to report this as a pilot, every small subset of those who on questionnaire measures. So parents would benefit in their sleep. What did they up to give it? 8 to 1 hour and more sleep, 15 with intervention? Exactly. There were improvements in sleep latency. And I’ll just say to anyone out there who’s interested, I know one of them for a long time.

Dr. Alex Richardson: The ones who seem to report anecdote to the they fit a particular pattern. They’re almost a delayed sleep phase type thing. They have trouble getting to sleep. They often all be anxious or that’s when they wake up, you know, to the day. But they’re also the ones who have trouble getting up in the morning. So it’s almost the adolescent know you’ve slept your whole circadian rhythm type thing.

Dr. Alex Richardson: So we did see improvements in sleep onset, but the sleep duration. So we get nearly an hour more sleep if they were on DHA versus placebo, that’s amazing. It reminds me of this rereading, of course, and you forgot some little detail. This actually showed up the most important finding of both Dunlop One and Two. No surprise to you guys.

Dr. Alex Richardson: It was completely safe. There were absolutely no adverse effects at all whatsoever. And we had put a very detailed, really adverse effect side effects. We assessed side effects, which is used in studies of ADHD to assess all of the possible side effects of medications. And they’re all there for the placebo.

Dr. Alex Richardson: Children are reporting that they have more sleep problems post-treatment than do the three or even in four. Did people know afterwards what treatment they were on.

Dr. Alex Richardson: You know what blinding maintained and yet that was true in both studies but we didn’t have a lot of data back up to but yeah what data we did get back the no difference. Well you brought up the sleep stuff and I know you’re starting a new study and you get your fatty, your fats and behavior research group, which is way even beyond fatty acids.

Dr. Alex Richardson: Right. Well, my goodness. What I’m ever so pleased about and this is a collaboration with Swansea University and a little unit in their oncology department. They, decades ago, were the first ever study to show that multi vitamins and minerals might boost children’s IQ cognition were done by Professor David Benton. He’s emeritus now but bless he’s still really willing to and come into the lab and will be helping to, you know, do some of the things like be independent third party you know with the of we would love to dig into this.

Dr. Alex Richardson: Can we do a part to another time. Well we can we know so much more to talk about and you were down and I want to compliment you on these podcasts of yours because I did finally find time to do was look through. Come along now. Who’ve you interviewed? What are these? What is fantastic? Oh, is that you haven’t yet covered the Depression one.

Dr. Alex Richardson: So although there’s many people better qualified than me, it is one. Yeah, Yeah, I know that story. Absolutely I do. And maybe we could bring you on as a tag team with somebody else in the Depression for you would be lovely. Well, let’s get Joe Hibbeln back. And he did the webinar recently. Let’s do it honestly. Now. Do people know more, let’s face it, than Joe Hibbeln when it comes to depression?

Dr. Bill Harris: We’re going to have to wrap up here but thank you so much for part one. And, you want to say anything about fab research, food and behavior research. We are entirely researcher led. We therefore are lucky enough to have the likes of Michael Crawford, Joe Hibberd, A.S., Bernadette Lewis, many others founded about 20 years ago just to disseminate.

Dr. Alex Richardson: To be honest, I really don’t try to fundraise, but we are tiny. We’re research led, but we’ve got a website, we’ve got a subscribing associate membership scheme. If anybody wants to help us, the importance of what we do and I’m going to absolutely a cue from your fabulous Omega Matters podcast. Just having discussions don’t even require them to make a presentation, just have a chat, just have a chat.

Dr. Alex Richardson: That is exactly it. Thank you for everything that you just bringing us through your career in the story of all of these papers. We will definitely have more to talk about. So you have to do this again. Thank you so much. I’d love to thank you for asking and we shall be in touch. All right. Thank you.

Dr. Alex Richardson: Take care. All right.

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