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NCT01366859 · ClinicalTrials.gov registry record · Phase 2
Nutritional Intervention in Children With Autism Using Whey Protein (Immunocal): Impact on Core Areas of Behavior
A Phase 2 study, sponsored by Nova Southeastern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT01366859: Completed Phase 2 study, sponsored by Nova Southeastern University.
NCT01366859 is a Phase 2 study that has completed, run by Nova Southeastern University. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01366859, a Phase 2 study, has completed, sponsored by Nova Southeastern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study 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.
Primary Outcome
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,
Interventions
- DIETARY_SUPPLEMENT Whey Protein
- DIETARY_SUPPLEMENT Rice Protein (Placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2011-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
What the finished NCT01366859 record still lists
NCT01366859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which Whey Protein is the first listed.
NCT01366859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01366859 about?
NCT01366859 is a clinical study titled "Nutritional Intervention in Children With Autism Using Whey Protein (Immunocal): Impact on Core Areas of 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.
What is the current status of trial NCT01366859?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2011-05. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01366859?
The interventions under investigation include: Whey Protein (DIETARY_SUPPLEMENT), Rice Protein (Placebo) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01366859?
This trial is sponsored by Nova Southeastern University, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01366859's enrollment target sits among peer trials
81 834th of 2000 higher than 1,159 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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