Study on Metabolic Processes and Cognitive Functions in Adults and Adolescents With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tryptophan turnover
研究概览
简要总结
The objective of this study is to gain preliminary information and knowledge on metabolic profile in ASD. The benefit of this study will be to expand our insight of the potential relationship in metabolic processes and neuropsychological functions in ASD. For example, based on the obtained data of the study we can determine whether there is a link between the tryptophan pathway and cognitive functions in autism. The project is based on a systematic and multidisciplinary approach using tracers for delineating the mechanism by which the metabolism of amino acids like TRP is involved in affective and cognitive functions in ASD. Using an innovative approach to the evaluation of amino acids has not been used in adults with ASD. In addition, the obtained data of the study holds promise to develop specific markers (metabolic and/or neuropsychological) for guiding the identification those individuals with increased risk of developing mood disturbances or cognitive impairment, and for predicting the therapeutic effect of a specific nutritional interventions in subjects with ASD.
详细描述
This study investigates the metabolic profile of different amino acids and cognitive functions in adults and adolescents with ASD in comparison with age- and gender-matched healthy young adults. The study involves 1 screening visit of approximately 2 hours and 1 study day of 5 hours
The objective is to explore changes in amino acids (e.g. TRP pathway) in ASD and evaluate the function of TRP in neuropsychological functions by using the technique of stable isotope and our newly developed 'single pulse method' with multiple amino acid and keto-acid isotopes.
The aim of this study is to determine the underlying mechanism by which the metabolism of amino acids such as TRP are involved in mood and cognitive functions in ADS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female according to the investigator's or appointed staff's judgment
- •Age 16 years or older
- •Ability to walk, sit down and stand up independently
- •Ability to lie in supine or elevated position for 4 hours
- •Willingness and ability to comply with the protocol
- •Inclusion criteria subjects with Autism Spectrum Disorder (ASD):
- •Healthy high functioning person diagnosed with autism spectrum disorder
- •Age 16 years or older
- •Ability to walk, sit down and stand up independently
- •Ability to lie in supine or elevated position for 4 hours
- •Willingness and ability to comply with the protocol
排除标准
- •Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy group)
- •Failure to give informed consent
- •Established diagnosis of Insulin Dependent Diabetes Mellitus
- •Metabolic diseases, including hepatic or renal disorders
- •Presence of acute illness or metabolically unstable chronic illness
- •Presence of fever within the last 3 days
- •Pre-planned surgery of procedures that would interfere with the conduct of the study
- •Any other condition according to the PI or study physician that would interfere with proper conduct of the study / safety of the patient
- •Current alcohol or drug abuse
- •Use of protein or amino acid containing nutritional supplements within 5 days prior to the study days
- •Use of long-term oral corticosteroids or short course of oral cortico-steroids 4 weeks preceding first test day
- •Body Mass Index of < 18.5 or ≥ 40 kg/m2
- •Montreal Cognitive Assessment score of < 20
研究组 & 干预措施
Healthy matched controls
Study Day: The subject will arrive fasted. A catheter will be inserted in the arm for stable isotope infusion and blood sampling. The hand of the arm used for blood sampling will be placed in a thermostatically controlled warmed box that heats the air. Immediately after a baseline blood sample is taken, an infusion with stable isotopes will be administered by the research nurse. Stable isotopes are given to measure amino acid metabolism. Blood samples will be collected before and/or after infusion. Subjects will be asked to complete a list of questions regarding quality of life, mood and depression, diet.
干预措施: stable isotope infusion (Other)
Adults with Autism Spectrum Disorder
The subject will arrive fasted. A catheter will be inserted in the arm for stable isotope infusion and blood sampling. The hand of the arm used for blood sampling will be placed in a thermostatically controlled warmed box that heats the air. Immediately after a baseline blood sample is taken, an infusion with stable isotopes will be administered by the research nurse. Stable isotopes are given to measure amino acid metabolism. Blood samples will be collected before and/or after infusion. Subjects will be asked to complete a list of questions regarding quality of life, mood and depression, diet.
干预措施: stable isotope infusion (Other)
结局指标
主要结局
Tryptophan turnover
时间窗: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
次要结局
- hydroxyproline breakdown (reflecting collagen breakdown)(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- glutamate turnover(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- Group differences in learning and memory as measured by Digit Span(1 day)
- Group differences in attention and executive functions as measured by Trail Making Test (TMT),(1 day)
- Group differences in attention and executive functions as measured by Brief-A(1 day)
- glutathione turnover(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- leucine turnover(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- Whole body myofibrillar protein breakdown rate (reflecting muscle protein breakdown)(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- urea production(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)(1 day)
- Adolescent/Adult Sensory Profile(1 day)
- Group differences in attention and executive functions as measured by PASAT(1 day)
- taurine turnover(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)(1 day)
- Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT),(1 day)
- Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS),(1 day)
- Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT),(1 day)
研究者
Marielle PKJ Engelen, PhD
Associate Professor
Texas A&M University