Meet Tim: he is an 8-year-old boy, living in the Netherlands with his parents and younger sister. A couple of years ago, Tim was diagnosed with Attention Deficit Hyperactivity/Impulsivity Disorder (ADHD). His psychologist recommended to participate in the TRACE study: this study examines the short- and long-term effects of dietary treatments in children with ADHD. In addition, the TRACE-BIOME study examines the underlying mechanisms of a dietary treatment. For this, we collect blood, stool and saliva samples and we perform a fMRI. These measurements might, among other things, shed light on the role of the brain-gut-axis.

But what’s it like to participate in a clinical trial? First of all, Tim was allocated to one of the two TRACE dietary treatments: an elimination diet or a healthy diet. Tim was allocated to the elimination diet. If we want to know if this diet is effective for Tim, we have to do a lot of different assessments (Figure 1).

Figure 1: assessments TRACE study
The TRACE Study, New Brain Nutrition

 

 

 

Before the baseline, 5 week and 1-year assessments, a couple of measurements already take place:

  • Tim wears an Actigraph one week before the assessment, which measures motor activity and sleep-wake rhythm;
  • Parents collect a stool sample from Tim in which his microbiota can be assessed;
  • Parents and teachers fill out different questionnaires about Tim’s behavior, but also about for example parenting styles;
  • Parents keep track of a food diary: what does Tim eat during two weekdays and one weekend day?

Before starting the elimination diet, Tim’s parents have a consult with one of the TRACE dieticians, so that they can prepare changing the diet of Tim. Then, it is time for the baseline assessment. Tim and his mother meet the researcher at the hospital for the blood venipuncture. He also has to chew on a cotton pad to collect a saliva sample. After this, they walk to Karakter which is a center for Child and Adolescent Psychiatry. The researcher measures his weight, length, blood pressure and heart rate. Next, Tim has to perform a task on the laptop which he really likes! This task assesses cognitive functions such as sustained attention, working memory and cognitive flexibility. After the computer task there is time for a break. Next, they start with a behavioral observation. In this task, Tim first plays with his mother and then with the researchers. The different tasks try to elicit ADHD symptoms and emotion (dys)regulation behavior. Finally, the MRI researcher takes Tim and his mother to the fMRI scanner in which he has to do two different tasks. All in all, the assessment takes about 4 hours.

After 5 weeks of the diet, it is time for the second assessment which is the same as the baseline assessment. The researcher has calculated, based on the parent and teacher questionnaires, if there is a significant response to the diet. Tim shows a 40% reduction of ADHD symptoms, which is a significant response! Therefore, they continue the diet. After 4 and 8 months of the diet, his parents receive some online questionnaires. Finally, after one year they are invited for the final assessment, which is again the same as the baseline assessment (without the fMRI).

 

The following YouTube video explains the assessments described above, in Dutch: ADHD en voeding: TRACE-onderzoek testdag

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Meet Tim: he is an 8-year-old boy, living in the Netherlands with his parents and younger sister. A couple of years ago, Tim was diagnosed with Attention Deficit Hyperactivity/Impulsivity Disorder (ADHD). His psychologist recommended to participate in the TRACE study: this study examines the short- and long term effects of dietary treatments in children with ADHD. In addition, the TRACE-BIOME study examines the underlying mechanisms of a dietary treatment. For this, we collect blood, stool, and saliva samples and we perform a fMRI. These measurements might, among other things, shed light on the role of the brain-gut-axis.

But what’s it like to participate in a scientific study? First of all, Tim was allocated to one of the two TRACE dietary treatments: an elimination diet or a healthy diet. Tim was allocated to the elimination diet. If we want to know if this diet is effective for Tim, we have to do a lot of different assessments (Figure 1).

Figure 1: assessments TRACE study

 

 

           

 

 

 

 


Before the baseline, 5 week and 1-year assessments, a couple of measurements already take place:

  • Tim wears an Actigraph one week before the assessment, which measures motor activity and sleep-wake rhythm;
  • Parents collect a stool sample from Tim in which his microbiota can be assessed;
  • Parents and teachers fill out different questionnaires about Tim’s behavior, but also about, for example, parenting styles;
  • Parents keep track of a food diary: what does Tim eat during two weekdays and one weekend day?

Before starting the elimination diet, Tim’s parents have a consult with one of the TRACE dieticians, so that they can prepare changing the diet of Tim. Then, it is time for the baseline assessment. Tim and his mother meet the researcher at the hospital for the blood venipuncture. He also has to chew on a cotton pad to collect a saliva sample. After this, they walk to Karakter which is a center for Child and Adolescent Psychiatry. The researcher measures his weight, length, blood pressure and heart rate. Next, Tim has to perform a task on the laptop which he really likes! This task assesses cognitive functions such as sustained attention, working memory, and cognitive flexibility. After the computer task, there is time for a break. Next, they start with behavioral observation. In this task, Tim first plays with his mother and then with the researchers. The different tasks try to elicit ADHD symptoms and emotion (dys)regulation behavior. Finally, the MRI researcher takes Tim and his mother to the fMRI scanner in which he has to do two different tasks. All in all, the assessment takes about 4 hours.

After 5 weeks of the diet, it is time for the second assessment which is the same as the baseline assessment. The researcher has calculated, based on the parent and teacher questionnaires, if there is a significant response to the diet. Tim shows a 40% reduction of ADHD symptoms, which is a significant response! Therefore, they continue the diet. After 4 and 8 months of the diet, his parents receive some online questionnaires. Finally, after one year they are invited for the final assessment, which is again the same as the baseline assessment (without the fMRI).

The following movie explains the assessments described above, in Dutch: 

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In every classroom, approximately two children are diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). They struggle with attention problems and hyperactive and impulsive behavior. This has negative consequences for these children. For example, they can have difficulties learning, it puts them at risk for other psychiatric problems, and it can cause parent-child relationship problems. Therefore, children with ADHD do need some sort of treatment for optimizing the quality of their lives.

After psycho-education to the child, parents and teacher, medication is often the first choice of treatment because it is evidence-based. However, there is a growing group of parents that do not wish to medicate their child. They are concerned about the side and long-term effects. Thus, these parents seek other treatment. That is where they get stuck: which other effective treatments are available?

In order to develop new treatments, there is a growing field of research focusing on risk factors for ADHD symptoms. One of these risk factors that has been studies increasingly is nutrition. Nutrition plays a role in physical well-being, but could also play a role in psychological well-being and cognitive functioning. Consequently, dietary treatments could be an alternative treatment for children with ADHD. There is a long history of research in nutrition, but there is not enough evidence yet about the cost-effectiveness to implement dietary treatments in clinical health care.

So far, studies examining the effectiveness of a so-called elimination diet showed the strongest effects (1). The aim of an elimination diet is to find out which products trigger ADHD symptoms. However, results of these studies are inconclusive because of several limitations. First, outcome measurements used in these studies were not objective. Second, studies suffered from a sample bias towards highly motivated and educated parents. Third, underlying mechanisms are still unknown. Fourth, long-term effects are unknown. Moreover, it is unknown if an elimination diet is more effective in reducing ADHD symptoms than a healthy diet based on the World Health Organization (WHO) guidelines (2).

We thought: can we take into account these limitations ánd examine the effectiveness of two dietary treatments? This resulted in the TRACE study: ‘Treatment of ADHD with Care as usual versus an Elimination diet’ (TRACE) study. This is the first study to determine the short- and long-term effectiveness and cost-effectiveness of two dietary treatments as initial addition to care as usual as a treatment trajectory for children with ADHD. We will substantially improve upon previous studies by implementing the intervention in non-commercial mental health centers, including blinded and objective measurements, and comparing two dietary treatments with care as usual. Also, understanding the biological effects could inform clinicians to potential markers and targets for preventative or individualized treatment. For this reason, we also examine the underlying biological mechanisms (e.g. mechanisms in the gut and brain) of dietary treatments (TRACE-BIOME and TRACE-MRI studies). We collect blood, stool and saliva samples.

The TRACE study is a two-arm randomized control trial: participants are randomized to either an elimination diet or a healthy diet. The comparator arm includes children who are being treated with care as usual. Currently, we included in each dietary treatment arm about half of the targeted participants (N=81 in each dietary group). In the care as usual group, we included about one-third of the targeted participants (N=60). We hope to finish inclusion around January 2020.

I am really looking forward to the results and hope to share this with you in a couple of years! If you have any questions, feel free to contact us via trace@karakter.com

REFERENCES
(1) Nigg, J. T., Lewis, K., Edinger, T., & Falk, M. (2012). Meta-analysis of attention- deficit/hyperactivity disorder or attention-deficit/hyperactivity disorder symptoms, restriction diet, and synthetic food color additives. Journal of the American Academy of Child & Adolescent Psychiatry, 51(1), 86-97. https://doi.org/10.1016/j.jaac.2011. 10.015 .
Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4321798/

(2) Izquierdo Pulido, M. L., Ríos Hernández, A., Farran, A., & Alda, J. Á. (2015). The role of diet and physical activity in children and adolescents with ADHD. Recent Advances in Pharmaceutical Sciences V, 2015, Research Signpost. Chapter 4, p. 51-64.
Link: http://diposit.ub.edu/dspace/bitstream/2445/67543/1/T_1444299316Munozv%204.pdf

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A little while ago, this blog featured an entry by Annick Bosch on the TRACE study, an amazing intervention study using the Elimination Diet to treat ADHD in kids (https://newbrainnutrition.com/adhd-and-elimination-diet/). Very shortly summarized, the Elimination Diet entails that participants can only eat a very restricted set of foodstuffs for several weeks, which can greatly reduce the number of ADHD symptoms in some kids. Subsequently, new foodstuffs are added back into the diet one by one, all the time checking that ADHD symptoms do not return. This ensures that every child for which the Elimination Diet proves successful ends up with a unique diet which suppresses their ADHD symptoms.

Now this is a fascinating study, since it indicates a direct influence of diet on ADHD behavior. What we know from the neurobiology of ADHD, is that it is caused by a myriad of relatively small changes in the structure, connectivity and functioning of several brain networks 1. For the most common treatments of ADHD, like medication with methylphenidate 2, we can quite accurately see the changes these interventions have on brain functioning. However, for the Elimination Diet, this has not been studied before at all. This is why we are now starting with the TRACE-MRI study, where kids that participate in a diet intervention in the TRACE program, are also asked to join for two sessions in an MRI scanner. Once before the start of the diet, and once again after 5 weeks, when the strictest phase of the Elimination Diet concludes. In the MRI scanner, we will look at the structure of the brain, at the connectivity of the brain, and at the functioning of the brain using two short psychological tasks. We made a short vlog detailing the experience of some of our first volunteers for this MRI session.

 

 

With the addition of this MRI session, we hope to be able to see the changes in brain structure and function over the first 5 weeks of the diet intervention. This will help us establish a solid biological foundation of how diet can influence the brain in general, and ADHD symptoms specifically. It can also show us if the effect of the Elimination Diet is found in the same brain networks and systems which respond to medication treatment. And lastly, we can see if there is a difference in the brains for those participants for whom the diet has a strong effect versus those where the diet does little or nothing to improve their ADHD symptoms. This can then help us identify for which people a dietary intervention would be a good alternative to standard treatment.

We will update you on the TRACE-MRI study and on the developments in this field right here on this blog!

 

REFERENCES
Faraone, S. V et al. Attention-deficit/hyperactivity disorder ­­­. Nat. Rev. Dis. Prim. 1, (2015).

Konrad, K., Neufang, S., Fink, G. R. & Herpertz-Dahlmann, B. Long-term effects of methylphenidate on neural networks associated with executive attention in children with ADHD: results from a longitudinal functional MRI study. J. Am. Acad. Child Adolesc. Psychiatry 46, 1633–41 (2007).

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When Alice’s mother first contacted our team to get more information on the dietary intervention at New Brain Nutrition, she mentioned that her daughter seems to be on edge all the time. On a typical day, Alice would be triggered easily over seemingly small things and stay upset for a long time. She told us that these emotional problems caused not only very strained and cheerless moments on the weekends and evenings, they also interfered notably with Alice’s social life. In between her angry or sad moments, Alice seems to be a perfectly happy and energetic 11-year old. Alice’s attention problems didn’t obstruct a healthy didactic development since she started ADHD-medication. However, the emotional problems were still present and seemed to cause severe impairment in social interactions, within the family and with peers. Therefore, her mother asked: Could we please try a dietary intervention to see if Alice’s nutrition may play a role in these problems?

Faraone[1] distinguishes two features in these kind of emotional problems: Emotional Impulsivity and Deficient Emotional Self-Regulation. Some children may experience explosive anger but also recover quickly from it. These children experience high Emotional Impulsivity but low Deficient Emotional Self-Regulation. Alice however, based on her mother’s narrative, seems to experience both high Emotional Impulsivity and high Deficient Emotional Self-Regulation.

The second week into the Elimination Diet treatment, the researcher checks in with the family: She’s still edgy and irritable for most of the time, her mother says, but she seems to break out of it a whole lot sooner. The other day her brother Daniel came home, telling Alice he ate lots of non-elimination diet snacks at his friend’s house. Understandably, Alice became upset but it didn’t last as long as her parents expected. In other words: The Emotional Impulsivity hadn’t decreased yet, but the Deficient Emotional Self-Regulation had.

By the end of the first 5 weeks of the dietary intervention, Alice’s parents reported a convincing decrease in emotion regulation problems. The teacher also reported that the attention problems had stabilized, as much as they did with the ADHD-medication that Alice had before. The family decided to continue the Elimination Diet and start with the re-introduction phase. Every two weeks a new product was re-introduced to see if this may elicit symptoms. This was probably the most interesting period for the family, as emotion regulation problems and attention problems arose and subsided over different phases.

After one year, Alice and her family had figured out a set of foods that, when eliminated from her diet, helped diminishing both the attention problems and emotional problems. Alice is less responsive to emotional triggers and more balanced during social interactions. Alice’s personalized diet or personalized nutrition is based on her experiences and symptoms during the dietary intervention. Her mother is very glad that they discovered this lifestyle intervention as an alternative to their previous treatment with ADHD-medication.

Writers note: This is the story of one individual participating in the New Brain Nutrition study. Evaluating the role of nutrition in treatment of mental health with scientific evidence is part of our future.

More information can be found in [1] Faraone S.V., Rostain A.L., Blader J., Busch B., Childress A.C., Connor D.F., & Newcorn J.H. (2018). Practitioner Review: Emotional dysregulation in attention‐deficit/hyperactivity disorder – implications for clinical recognition and intervention. Journal of Child Psychology and Psychiatry. https://doi.org/10.1111/jcpp.12899

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