Nutritional Intervention in Children With Autism Using Whey Protein (Immunocal): Impact on Core Areas of Behavior
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effects of a cysteine-rich whey protein isolate supplement
      (Immunocal®) on autistic behavior in pre-school children with autism.
    

Detailed description: 
      Summary:

      Autism is a neurodevelopmental disorder currently affecting as many as 1 of 150 children in
      the United States. Autism is considered by many to be a permanent condition with little hope
      for improvement. The treatment for autism is centered on special schooling and behavioral
      therapy; and conventional medical treatments have had little impact on ameliorating this
      disorder. Recent research has discovered that some autistic individuals have increased
      markers of oxidative stress and some degree of mitochondrial dysfunction. Furthermore,
      genetic abnormalities in the glutathione pathway have been associated to autism. Thus, we are
      proposing that a nutritional supplement based on bovine milk serum containing cysteine-rich
      whey proteins serving as glutathione precursors can improve behavioral function in children
      with Autism.

      Hypothesis:

      Many children with autism have impaired antioxidant/detoxification capacity and chronic
      oxidative stress. Studies have also shown that autistic children show an abnormally high
      prevalence of glutathione deficiency. A cysteine-rich whey protein supplement demonstrated to
      raise glutathione levels will improve the metabolic imbalance and improve measures of
      autistic behavior.

      Purpose:

      This study will evaluate the effects of a cysteine-rich whey protein isolate supplement
      (Immunocal®) on autistic behavior in pre-school children with autism.

      Methods:

      This will be a 3 month double-blind placebo-controlled study. A total of 60 subjects will be
      selected/recruited and enrolled (see inclusion and exclusion criteria) to have a minimum 40
      evaluable children (including estimated drop-outs) ranging in age from 3 to 5 years old to
      participate in the study and data recorded and collected. Children will be randomly assigned
      to either treatment- to the study product (Immunocal) or to the control (rice protein) for
      three months (20 subjects per group). Core areas of autistic behavior that will be assessed
      before (baseline/week 0), and at the end of treatment (week 12) are: atypical autistic
      behaviors and severity, communication, developmental status and behavioral problems. In
      addition, blood glutathione levels will be quantified before and after treatment. Side
      effects and adverse reactions will be compared between the two groups before (baseline/week
      0) and at the end of treatment (week 12).
    

Intervention name(s): Whey Protein; Rice Protein (Placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The experimental study group will consist of thirty children that will be treated with Immunocal® 0.5 g/kg if less than 18 kg of body weight or 10 g/day for those children over 18 kg of body weight for three months to determine the supplement's effect in core areas of behavior in children with autism.; The control or placebo study group will consist of thirty children that will be treated with rice protein (placebo) 0.5 g/kg if less than 18 kg of body weight or 10 g/day for those children over 18 kg of body weight for three months.
Other intervention name(s): Immunocal; Cystine-rich Whey Protein Isolate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Autism; Children; Behavior; Glutathione; Whey Protein; Immunocal; Antioxidant