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Autism Spectrum DisordersPhase 2NCT01366859

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

A Phase 2 study testing Whey Protein in people with Autism Spectrum Disorders, run by Nova Southeastern University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 5 years
Conditions the study is for
Autism Spectrum Disorders
What is being tested?
Whey Protein
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
3 sitesUnited States
Study dates
May 2011to Oct 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosis of autism according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
  • Male/female
  • Aged 3-5 years

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mailman Segal Center

    Fort Lauderdale, Florida, 33314

  • Nova Southeastern University Clinic

    Fort Lauderdale, Florida, 33328

  • Nova Southeastern University, College of Pharmacy

    Fort Lauderdale, Florida, 33328

Other trials in United States

About this study

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

This study will evaluate the effects of a cysteine-rich whey protein isolate supplement (Immunocal®) on autistic behavior in pre-school children with autism.

Read the 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).

Being tested
Whey Protein, Rice Protein (Placebo)
Keywords
Autism, Children, Behavior, Glutathione, Whey Protein, Immunocal, Antioxidant
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whey ProteinDietary supplement

    Also called Immunocal, Cystine-rich Whey Protein Isolate

    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.

  • 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.

Study groups in NCT01366859
Study groupRoleWhat they receive
Whey Protein (Immunocal®)ExperimentalThe 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.
Receives: Dietary Supplement: Whey Protein
Placebo: Rice ProteinPlacebo comparatorThe 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.
Receives: Dietary Supplement: Rice Protein (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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,

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

Secondary outcomes (2)

  1. Safety Analysis

    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.

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

  2. Intracellular Glutathione & Antioxidant Capacity

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01366859
Sponsor's protocol ID
01291001F
Status last verified
Mar 2016
First submitted
2 Jun 2011
Last updated
3 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34658941

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Whey Protein in people with Autism Spectrum Disorders, run by Nova Southeastern University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behavioral Analysis (time frame: Outcome measure assessed at baseline (week 0) and week 12.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01366859, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016; AzTrials last refreshed its copy on 3 Nov 2026.

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