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

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorders

In brief

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

Key facts

Study ID

NCT01366859

Run by

Nova Southeastern University

People needed

81

Starts

2011-05-01

Expected to finish

2016-10-01

Last updated by the study team

2016-11-03

Who can join

Age: 3 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of autism according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
• Male/female
• Aged 3-5 years

You may not qualify if…

• 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

Where it is running

• Mailman Segal Center — Fort Lauderdale, Florida, United States
• Nova Southeastern University Clinic — Fort Lauderdale, Florida, United States
• Nova Southeastern University, College of Pharmacy — Fort Lauderdale, Florida, United States

Full record on ClinicalTrials.gov

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