Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT01366859
Status:
COMPLETED
Last Update Posted:
2016-11-03
First Post:
2011-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Intervention in Children With Autism Using Whey Protein (Immunocal): Impact on Core Areas of Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067816', 'term': 'Whey Proteins'}], 'ancestors': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-02', 'studyFirstSubmitDate': '2011-06-02', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavioral Analysis', 'timeFrame': 'Outcome measure assessed at baseline (week 0) and week 12.', 'description': '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,'}], 'secondaryOutcomes': [{'measure': 'Safety Analysis', 'timeFrame': 'Outcome measure assessed at baseline (week 0) and week 12.', 'description': '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.'}, {'measure': 'Intracellular Glutathione & Antioxidant Capacity', 'timeFrame': 'Outcome measured at baseline (week 0) and week 12.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Autism', 'Children', 'Behavior', 'Glutathione', 'Whey Protein', 'Immunocal', 'Antioxidant'], 'conditions': ['Autism Spectrum Disorders']}, 'referencesModule': {'references': [{'pmid': '34658941', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effects of a cysteine-rich whey protein isolate supplement (Immunocal®) on autistic behavior in pre-school children with autism.', 'detailedDescription': 'Summary:\n\nAutism 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.\n\nHypothesis:\n\nMany 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.\n\nPurpose:\n\nThis study will evaluate the effects of a cysteine-rich whey protein isolate supplement (Immunocal®) on autistic behavior in pre-school children with autism.\n\nMethods:\n\nThis 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of autism according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)\n* Male/female\n* Aged 3-5 years\n\nExclusion Criteria:\n\n* Milk Allergy\n* Rice allergy\n* Nut Allergy\n* Major medical problems including cardiac, liver endocrine or renal disease\n* History of seizure disorder or gross neurological deficit\n* Concomitant treatment with psychiatric medication\n* Current diet supplementation with N-acetyl-cysteine, alpha lipoic acid or whey protein.\n* Comorbid diagnosis: Fragile X syndrome, tuberous sclerosis, phenylketonuria or fetal alcohol syndrome\n* Acute illness'}, 'identificationModule': {'nctId': 'NCT01366859', 'briefTitle': 'Nutritional Intervention in Children With Autism Using Whey Protein (Immunocal): Impact on Core Areas of Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Nova Southeastern University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '01291001F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whey Protein (Immunocal®)', 'description': '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.', 'interventionNames': ['Dietary Supplement: Whey Protein']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo: Rice Protein', 'description': '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.', 'interventionNames': ['Dietary Supplement: Rice Protein (Placebo)']}], 'interventions': [{'name': 'Whey Protein', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Immunocal', 'Cystine-rich Whey Protein Isolate'], 'description': "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.", 'armGroupLabels': ['Whey Protein (Immunocal®)']}, {'name': 'Rice Protein (Placebo)', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Placebo: Rice Protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33314', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Mailman Segal Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33328', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Southeastern University Clinic', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33328', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Southeastern University, College of Pharmacy', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}], 'overallOfficials': [{'name': 'Ana Maria Castejon, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'College of Pharmacy, Nova Southeastern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Southeastern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Immunotec Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ana Maria Castejon Ph.D.', 'investigatorAffiliation': 'Nova Southeastern University'}}}}