None listed
Conditions
Brief summary
There is now a growing amount of research supporting the notion of communication between gut microbiota (microorganisms; e.g. ecoli, streptococcus) and the central nervous system (CNS) (known as the brain-gut axis). According to Cryan and Dinan (2012) communication between the gut and CNS may be occurring through neural, endocrine and immune pathways indicating the possibility of alterations to gut microbiota as a form of therapy for treatment of CNS related disorders. According to a review by Kidd (2000) integrative treatments such as correction of intestinal dysbiosis, nutritional supplementation and dietary modifications can be a successful way to help children with ADHD reduce symptoms and move towards a productive and normal life. A review by Stevens, Kuczek, Burgess, Hurt, and Arnold (2011) states that there are a number of studies that have found encouraging results in ADHD children following an elimination diet (Pelsser et al., 2011; Pelsser et al., 2009) and diets challenging with or removing any artificial food dyes (Bateman et al., 2004; McCann et al., 2007). This review supported the use of dietary interventions in at least subpopulations of ADHD children, concluding diets that removed artificial colours significantly improve symptoms that return when challenged (Stevens et al., 2011). These authors also concluded that elimination diets would be an appropriate intervention for children who have not responded satisfactorily to traditional treatment. Moreover, Villagomez and Ramtekkar (2014) concluded that the use of nutritional supplementation in children with ADHD may be a justified and importantly safe intervention, where a number of studies have observed improvements in ADHD related symptomatology following nutritional supplementation (Bilici et al., 2004; Harding, Judah,& Gant, 2003; Hawkey & Nigg, 2014; Huss, Volp, & StaussGrabo, 2010). Further, due to the understanding of the microbiome’s connection to neurodevelopment, it is compelling to consider the role it is likely to play in disorders such as ADHD (Theije et al., 2014). Unlike autism spectrum disorders (ASDs), there have been no studies investigating the microbial composition and status of ADHD children, which could help provide some important insights into the effects of food or food allergy on behaviour (Theije et al., 2014). Previously no study has investigated the effects of diet and nutrition upon psychological functioning (cognition, brain activity, and sleep), together with gut microbial composition in this population. This is important because investigations of gut composition have to date largely been ignored in children with ADHD (Theije et al., 2014) and this information could be used as an important indicator to guide clinical decisions on an individualised level. Although this study is applying a standardised protocol in the interests of experimental control, this information could still be important for future individualized treatments.
Interventions
The first appointment involved in the trial is with Dr Jacques Duff. He will explain the dietary and nutritional supplementation requirements of the study to parents of participants and answer any questions they may have about the treatment protocol. Dr Duff is a Registered Psychologist and also Neuroscientist and Nutritionist. Participants will be asked to not start their child on the diet and supplements until after their next visit (where all baseline testing will take place). He will also pr
The first appointment involved in the trial is with Dr Jacques Duff. He will explain the dietary and nutritional supplementation requirements of the study to parents of participants and answer any questions they may have about the treatment protocol. Dr Duff is a Registered Psychologist and also Neuroscientist and Nutritionist. Participants will be asked to not start their child on the diet and supplements until after their next visit (where all baseline testing will take place). He will also provide parents with a kit and instructions on how to collect a faecal sample from your child that will be sent by courier to Bioscreen Medical for analysis. Please see the attached nutrition form for details about the administration and dosage requirements for the nutritional supplements in the study. The 6 month dietary alteration period eliminates all additives, preservatives, food colourings, gluten (in particular wheat), dairy products, cereal grains, excess sugar and refined carbohydrates. Patients are encouraged to eat more fish, fruit, vegetables, legumes, pulses and selenium containing foods (e.g., Brazil nuts). They are also encouraged to eat eggs, beef, free range chicken and goats meat in moderation. The nutritional supplementation includes Fish oils, zinc citrate, vitamin E, magnesium, cognisense, vitamin C and vitamin D3. As outlined in the Information to Participants in Research document, dietary compliance will be monitored by at each of the bimonthly appointments at the clinic and by parents via a monthly diary which will be made available either online or hard copy.
Sponsors
Victoria University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
Participants will be required to have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). People with ADHD display persistent patterns of inattention and/or hyperactivity-impulsivity that interferes with functioning or development.
Exclusion criteria
No significant co-morbidities (for example a diagnosis of autism or depression as well as ADHD).
Outcome results
None listed