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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 6
- 主要终点
- Behavioral Analysis
研究概览
简要总结
This study will evaluate the effects of a cysteine-rich whey protein isolate supplement (Immunocal®) on autistic behavior in pre-school children with autism.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of autism according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- •Male/female
- •Aged 3-5 years
排除标准
- •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
结局指标
主要结局
Behavioral Analysis
时间窗: 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,
次要结局
- Intracellular Glutathione & Antioxidant Capacity(Outcome measured at baseline (week 0) and week 12.)
- Safety Analysis(Outcome measure assessed at baseline (week 0) and week 12.)
研究者
Ana Maria Castejon Ph.D.
Associate Professor
Nova Southeastern University