Nutritional Intervention in Children With Autism Using Whey Protein (Immunocal): Impact on Core Areas of Behavior

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).

Inclusion Criteria:

- Diagnosis of autism according to the Diagnostic and Statistical Manual of Mental
Disorders (DSM-IV)

- Male/female

- Aged 3-5 years

Exclusion Criteria:

- Milk Allergy

- Rice allergy

- Nut Allergy

- Major medical problems including cardiac, liver endocrine or renal disease

- History of seizure disorder or gross neurological deficit

- Concomitant treatment with psychiatric medication

- Current diet supplementation with N-acetyl-cysteine, alpha lipoic acid or whey
protein.

- Comorbid diagnosis: Fragile X syndrome, tuberous sclerosis, phenylketonuria or fetal
alcohol syndrome

- Acute illness