Fatty acid supplements alter biological signatures in children with Autism Spectrum Disorder

脂肪酸补充剂改变自闭症谱系障碍儿童的生物特征

• 批准号: 10480779
• 负责人: Sarah Keim
• 金额: $ 40.05万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10480779
• 关键词: Adverse event; Affect; Age; Anti-Inflammatory Agents; Behavior Disorders; Biological; Biological Availability; Child; Clinical; Conflict (Psychology); Consumption; Data; Diagnosis; Docosahexaenoic Acids; Docosahexaenoic acid supplementation; Dose; Eicosapentaenoic Acid; Erythrocytes; Family; Fatty Acids; Fish Oils; Formulation; Foundations; Future; Goals; Inflammation; Infrastructure; Interferon Type II; Interleukin-1 beta; Interleukin-2; Lifestyle-related condition; Natural Products; Obesity; Omega-3 Fatty Acids; Outcome; Parents; Participant; Pathway interactions; Patients; Personal Satisfaction; Pharmaceutical Preparations; Phase; Physiological; Plant Extracts; Plasma; Population; Property; Psyche structure; Publishing; Quality of life; Randomized; Reporting; Research; Research Personnel; Safety; Sampling; Specific qualifier value; Supplementation; Symptoms; Testing; Variant; Vitamins; Weight; autism spectrum disorder; autistic children; base; borage oil; clinical research site; clinically significant; comorbidity; design; dietary supplements; dosage; effective therapy; efficacy trial; evidence base; externalizing behavior; fatty acid supplementation; gamma-Linolenic Acid; gastrointestinal; inflammatory marker; physical symptom; primary endpoint; recruit; stem; symptomatic improvement

ABSTRACT Fatty acid supplements are among the most popular complementary products consumed by children with Autism Spectrum Disorder (ASD), driven by anecdotal evidence of benefit and a few small RCTs that demonstrated improvements in externalizing behaviors. Because no approved drugs exist to treat the core symptoms of ASD, well-intentioned parents are reaching for any product that may help their child. The implications are that fatty acid supplements are given to children without any evidence base as to their function, mechanism of action, effective dose, or benefits versus harms. Over-the-counter (OTC) fatty acid supplements are plentiful and consist of varying fatty acid compositions and often contain other ingredients. Recent evidence from our group and others suggest a combination of fish and borage oils providing supplementation of DHA, EPA and GLA (“Omega 3-6”) is particularly promising compared to other formulations. A critical need exists to evaluate Omega 3-6 for optimal dosing and changes in a physiologically relevant biological signature related to ASD symptoms, before a rigorous, full-scale efficacy trial can be launched. Our objective is to evaluate the effects of higher doses of Omega 3-6 on pre-specified biological signatures Our overall hypothesis is that optimal dosing of Omega 3-6 will alter biological signatures in a manner that correlates with improvements in ASD-related behaviors. The R61 phase of this proposal will test the hypothesis that Omega 3-6 will produce a clinically-significant reduction (improvement) in one or more the inflammatory markers IL-1β, IL-2, and IFNγ and our higher doses will demonstrate bioavailability, safety, and tolerability. The R33 phase of this proposal will test the hypothesis that the impact on biological signatures correlates with Omega 3-6 dose, can be replicated in a new sample of patients, and the change in key inflammatory marker(s) are correlated with core ASD symptoms after supplementation. Upon completion of this proposed 2-phase project, we expect to have identified an optimal dosing range for which Omega 3-6 exerts its effect on inflammation and, subsequently, on ASD symptoms in children. Such results are expected to have an important positive impact by laying the necessary groundwork for a full-scale efficacy trial to evaluate the effect of Omega 3-6 on ASD symptom improvement.

摘要

项目成果

Randomized Controlled Trial of Omega-3 and -6 Fatty Acid Supplementation to Reduce Inflammatory Markers in Children with Autism Spectrum Disorder.

• DOI: 10.1007/s10803-021-05396-9
• 发表时间: 2022-12
• 期刊: JOURNAL OF AUTISM AND DEVELOPMENTAL DISORDERS
• 影响因子: 3.9
• 作者: Keim, Sarah A.;Jude, Abigail;Smith, Katie;Khan, Aiman Q.;Coury, Daniel L.;Rausch, Joseph;Udaipuria, Shivika;Norris, Megan;Bartram, Lindsay R.;Narayanan, Anita R.;Rogers, Lynette K.
• 通讯作者: Rogers, Lynette K.