Autism Spectrum Disorders
Conditions
Keywords
Autism, Children, Behavior, Glutathione, Whey Protein, Immunocal, Antioxidant
Brief 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).
Interventions
DIETARY_SUPPLEMENTWhey Protein
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.
DIETARY_SUPPLEMENTRice Protein (Placebo)
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.
Sponsors
Immunotec Inc.
Nova Southeastern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Analysis | Outcome measure assessed at baseline (week 0) and week 12. | Behavioral analysis will be performed in areas of autism behaviors and severity, communication, developmental status and behavioral problems to establish the effects of a 90 day diet supplementation with a cysteine-rich whey protein isolate (Immunocal®) on autistic behavior in children with a diagnosis of autism according to DSM-IV, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Analysis | Outcome measure assessed at baseline (week 0) and week 12. | Safety analyses will be conducted to identify any adverse event during the course of the study, doing so will verify the tolerability of a cysteine-rich whey protein supplement (Immunocal®) in children with autism. |
| Intracellular Glutathione & Antioxidant Capacity | Outcome measured at baseline (week 0) and week 12. | Reduced and oxidized Glutathione levels in white blood cells will be quantified and correlated with behavioral changes in children with autism supplemented with a cysteine-rich whey protein. |
Countries
United States
Outcome results
None listed