Nutritional Intervention in Children With Autism Using Whey Protein (Immunocal): Impact on Core Areas of Behavior
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01366859|
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : November 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Dietary Supplement: Whey Protein Dietary Supplement: Rice Protein (Placebo)||Phase 2|
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.
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.
This study will evaluate the effects of a cysteine-rich whey protein isolate supplement (Immunocal®) on autistic behavior in pre-school children with autism.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, 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|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
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.
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.
- 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,
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366859
|United States, Florida|
|Nova Southeastern University Clinic|
|Fort Lauderdale, Florida, United States, 33328|
|Nova Southeastern University, College of Pharmacy|
|Fort Lauderdale, Florida, United States, 33328|
|Mailman Segal Center|
|Ft. Lauderdale, Florida, United States, 33314|
|Principal Investigator:||Ana Maria Castejon, Ph.D.||College of Pharmacy, Nova Southeastern University|