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

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ClinicalTrials.gov Identifier: NCT01366859
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : November 3, 2016
Sponsor:
Collaborator:
Immunotec Inc.
Information provided by (Responsible Party):
Ana Maria Castejon Ph.D., Nova Southeastern University

Tracking Information
First Submitted Date  ICMJE June 2, 2011
First Posted Date  ICMJE June 6, 2011
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE May 2011
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2011)
Behavioral Analysis [ Time Frame: 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,
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01366859 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2011)
  • Safety Analysis [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutritional Intervention in Children With Autism Using Whey Protein (Immunocal): Impact on Core Areas of Behavior
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Autism Spectrum Disorders
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Whey Protein
  • 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.
    Intervention: Dietary Supplement: Rice Protein (Placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2016)
81
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2011)
60
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01366859
Other Study ID Numbers  ICMJE 01291001F
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ana Maria Castejon Ph.D., Nova Southeastern University
Study Sponsor  ICMJE Nova Southeastern University
Collaborators  ICMJE Immunotec Inc.
Investigators  ICMJE
Principal Investigator: Ana Maria Castejon, Ph.D. College of Pharmacy, Nova Southeastern University
PRS Account Nova Southeastern University
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP