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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Nova Southeastern University
Sponsor:
Collaborator:
Immunotec Inc.
Information provided by (Responsible Party):
Ana Maria Castejon Ph.D., Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT01366859
First received: June 2, 2011
Last updated: April 16, 2014
Last verified: February 2013
  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.


Condition Intervention Phase
Autism Spectrum Disorders
Dietary Supplement: Whey Protein
Dietary Supplement: Rice Protein (Placebo)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:
  • Behavioral Analysis [ Time Frame: Outcome measure assessed at baseline (week 0) and week 12. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Safety Analysis [ Time Frame: Outcome measure assessed at baseline (week 0) and week 12. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Outcome measured at baseline (week 0) and week 12. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whey Protein (Immunocal®)
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.
Dietary Supplement: Whey 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.
Other Names:
  • Immunocal
  • Cystine-rich Whey Protein Isolate
Placebo Comparator: Placebo: Rice Protein
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.
Dietary Supplement: Rice 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.

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

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366859

Contacts
Contact: Ana Maria Castejon, Ph.D. 954-262-1396 castejon@nova.edu

Locations
United States, Florida
Nova Southeastern University Clinic Recruiting
Fort Lauderdale, Florida, United States, 33328
Contact: Edward E Packer, D.O.    954-262-1656    epacker@nova.edu   
Sub-Investigator: Edward E Packer, D.O.         
Sub-Investigator: Bruce Peters, D.O.         
Sub-Investigator: Rogerio Faillace, M.D.         
Nova Southeastern University, College of Pharmacy Recruiting
Fort Lauderdale, Florida, United States, 33328
Contact: Ana Maria Castejon, Ph.D.    954-262-1396    castejon@nova.edu   
Principal Investigator: Ana Maria Castejon, Ph.D.         
Mailman Segal Center Recruiting
Ft. Lauderdale, Florida, United States, 33314
Contact: Nurit Sheinberg, Ed.D.    954-262-7136    nurit@nova.edu   
Sub-Investigator: Roni Leiderman, Ph.D,         
Sub-Investigator: Nurit Sheinberg, Ed.D.         
Sub-Investigator: Susan Kabot, Ed.D.         
Sponsors and Collaborators
Nova Southeastern University
Immunotec Inc.
Investigators
Principal Investigator: Ana Maria Castejon, Ph.D. College of Pharmacy, Nova Southeastern University
  More Information

No publications provided

Responsible Party: Ana Maria Castejon Ph.D., Associate Professor, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT01366859     History of Changes
Other Study ID Numbers: 01291001F
Study First Received: June 2, 2011
Last Updated: April 16, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Nova Southeastern University:
Autism
Children
Behavior
Glutathione
Whey Protein
Immunocal
Antioxidant

Additional relevant MeSH terms:
Autistic Disorder
Food Habits
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Habits

ClinicalTrials.gov processed this record on July 31, 2014