a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)
Condition: Autism; Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder
MeSH terms: Hyperkinesis; Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Under double-blind, placebo-controlled, cross-over conditions, the short-term effects of use
      of A1 beta casein free milk (a2 milk) and milk containing A1 beta casein will be compared in
      a sample of pre-pubescent boys diagnosed with an autism spectrum disorder (ASD) with
      concurrent features of attention-deficit hyperactivity disorder (ADHD).
    

Detailed description: 
      Previous preliminary research studies have suggested that a diet devoid of milk and dairy
      products might be useful for some people on the autism spectrum in reducing certain types of
      behaviours or other symptoms that can affect quality of life. Aggravation of some of the
      symptoms of autism has been suggested to be linked to some of the constituents of milk, in
      particular a natural breakdown product of the milk protein called beta-casomorphin 1-7 (BC
      1-7 or BCM-7) found in the majority of mammalian dairy products. A dairy-free diet
      (casein-free diet) can however be a difficult diet to follow and may increase the risk that
      certain nutrients are missing from the diet.

      Anecdotal evidence suggests that different types of milk from different breeds of cattle
      (cows) may not carry the same biological effects for some on the autism spectrum. Milk
      typically found in supermarkets naturally contains BC1-7 as a function of the type of cows
      producing the milk and the protein it contains (A1 variant of the beta casein protein).

      The investigators are aiming to test whether a particular type of milk (A1 beta casein free
      milk also called a2 Milk™) might be able to replace a casein-free diet for children on the
      autism spectrum also presenting with attention-deficit hyperactivity disorder (ADHD) type
      symptoms. The investigators will be looking at the potential effects of A1 beta casein free
      milk on behaviour and various biological processes going on in the body. The source of A1
      beta casein free milk will be commercially available a2 Milk™ branded milk that is directly
      comparable to regular supermarket bought milk with the exception of the beta casein component
      and is already available to buy.

      In this double-blind, randomised, placebo-controlled trial, the effects of milk free of A1
      beta casein (a branded milk called a2 milk™) and milk containing A1 beta casein will be
      compared in a sample of pre-pubescent children diagnosed with an autism spectrum disorder
      with concurrent features of attention-deficit hyperactivity disorder (ADHD). Forty children
      based in North East England will be initially recruited; all possessing communicative speech
      and language. A baseline assessment will be conducted to include behavioural, psychometric
      and health-related parameters. Following random allocation, participants will be assigned to
      group A or group B and given A1 milk or a2 Milk™ initially for a period of 4 weeks. At this
      point, baseline assessment measures will be repeated. Milk types will be crossed for groups
      for a further 4 weeks. At study endpoint, baseline assessment measures will be repeated
      again. Data derived from the study will be analysed and outcomes reported in peer-review
      format. During the course of the study, all other forms of dairy product consumption (cheese,
      yogurts, etc) will be excluded from the diet of all participants irrespective of their
      treatment allocation.

      Data from supervised baseline, midpoint and endpoint psychometric and behavioural assessments
      will be made and stored via a secure survey website accessed via tablets supplied to all
      participants.
    

Intervention name(s): a2 milk; a1 containing milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): replace all milk with a2 milk; use a1 containing milk
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment