Clinical trial NCT01366859: Nutritional Intervention in Children With Autism Using Whey Protein (Immunocal): Impact on Core Areas of Behavior
Official title: Nutritional Intervention Using Supplementation With Cysteine-Rich Whey Protein Isolate (Immunocal®) in Children With Autism: Effects in Core Areas of Behavior- A Randomized Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorders
Keywords: Autism
Children
Behavior
Glutathione
Whey Protein
Immunocal
Antioxidant
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: Immunotec Inc.
First posted: 2011-06-06
Enrollment: 81
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

Eligibility criteria: 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

Primary outcomes:
measure: Behavioral Analysis
timeFrame: Outcome measure assessed at baseline (week 0) and week 12.
Secondary outcomes:
measure: Safety Analysis
timeFrame: Outcome measure assessed at baseline (week 0) and week 12.
measure: Intracellular Glutathione & Antioxidant Capacity
timeFrame: Outcome measured at baseline (week 0) and week 12.
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University Clinic
state: Florida
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University, College of Pharmacy
state: Florida
city: Ft. Lauderdale
country: United States
facility: Mailman Segal Center
state: Florida
Study officials:
affiliation: College of Pharmacy, Nova Southeastern University
name: Ana Maria Castejon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castejon AM, Spaw JA, Rozenfeld I, Sheinberg N, Kabot S, Shaw A, Hardigan P, Faillace R, Packer EE. Improving Antioxidant Capacity in Children With Autism: A Randomized, Double-Blind Controlled Study With Cysteine-Rich Whey Protein. Front Psychiatry. 2021 Sep 30;12:669089. doi: 10.3389/fpsyt.2021.669089. eCollection 2021.