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

Nova Southeastern University (NSU)

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorders

Treatments: Dietary Supplement: Rice Protein (Placebo); Dietary Supplement: Whey Protein

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01366859

01291001F

Details and patient eligibility

About

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

Full 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).

Enrollment: 81 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

81 participants in 2 patient groups, including a placebo group

Whey Protein (Immunocal®)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Whey Protein

Placebo: Rice Protein

Placebo Comparator group

Description:

The control or placebo study arm will consist of thirty children who will receive a dose of 0.5 g/kg of weight a day up to 18 kg of weight a day or a dose of 10 g/day for those over 18 kg for three months.

Treatment:

Dietary Supplement: Rice Protein (Placebo)