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

NCT01366859 | Completed Phase 2

• 1 other identifier: 01291001F
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 3

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.

Conditions

Autism Spectrum Disorders

Keywords

Autism; Children; Behavior; Glutathione; Whey Protein; Immunocal; Antioxidant

Outcome Measures

Primary Outcomes (1)

• Behavioral Analysis

  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,

  Outcome measure assessed at baseline (week 0) and week 12.

Secondary Outcomes (2)

• Safety Analysis

  Outcome measure assessed at baseline (week 0) and week 12.

• Intracellular Glutathione & Antioxidant Capacity

  Outcome measured at baseline (week 0) and week 12.

Study Arms (2)

Whey Protein (Immunocal®)

EXPERIMENTAL

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

Placebo: Rice Protein

PLACEBO COMPARATOR

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)

Interventions

Whey Protein DIETARY_SUPPLEMENT

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.

Also known as: Immunocal, Cystine-rich Whey Protein Isolate

Whey Protein (Immunocal®)

Rice Protein (Placebo) DIETARY_SUPPLEMENT

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.

Placebo: Rice Protein

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Nova Southeastern University: lead
• Immunotec Inc.: collaborator

Study Sites (3)

Mailman Segal Center

Fort Lauderdale, Florida, 33314, United States

Location

Nova Southeastern University Clinic

Fort Lauderdale, Florida, 33328, United States

Location

Nova Southeastern University, College of Pharmacy

Fort Lauderdale, Florida, 33328, United States

Location

Related Publications (1)

• 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.

  PMID: 34658941 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Behavior

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ana Maria Castejon, Ph.D.

  College of Pharmacy, Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 6, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 3, 2016

Record last verified: 2016-03

Locations

US (3)