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
基本信息
- 批准号:10480779
- 负责人:
- 金额:$ 40.05万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:Adverse eventAffectAgeAnti-Inflammatory AgentsBehavior DisordersBiologicalBiological AvailabilityChildClinicalConflict (Psychology)ConsumptionDataDiagnosisDocosahexaenoic AcidsDocosahexaenoic acid supplementationDoseEicosapentaenoic AcidErythrocytesFamilyFatty AcidsFish OilsFormulationFoundationsFutureGoalsInflammationInfrastructureInterferon Type IIInterleukin-1 betaInterleukin-2Lifestyle-related conditionNatural ProductsObesityOmega-3 Fatty AcidsOutcomeParentsParticipantPathway interactionsPatientsPersonal SatisfactionPharmaceutical PreparationsPhasePhysiologicalPlant ExtractsPlasmaPopulationPropertyPsyche structurePublishingQuality of lifeRandomizedReportingResearchResearch PersonnelSafetySamplingSpecific qualifier valueSupplementationSymptomsTestingVariantVitaminsWeightautism spectrum disorderautistic childrenbaseborage oilclinical research siteclinically significantcomorbiditydesigndietary supplementsdosageeffective therapyefficacy trialevidence baseexternalizing behaviorfatty acid supplementationgamma-Linolenic Acidgastrointestinalinflammatory markerphysical symptomprimary endpointrecruitstemsymptomatic improvement
项目摘要
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.
抽象的
脂肪酸补充剂是自闭症谱系障碍 (ASD) 儿童最流行的补充产品之一,其益处的轶事证据和一些小型随机对照试验表明,脂肪酸补充剂可以改善外化行为。由于没有批准的药物可以治疗自闭症谱系障碍的核心症状,善意的父母正在寻求任何可能帮助他们的孩子的产品。这意味着,在没有任何关于其功能、作用机制、有效剂量或利弊的证据基础的情况下,向儿童提供脂肪酸补充剂。非处方 (OTC) 脂肪酸补充剂很丰富,由不同的脂肪酸成分组成,并且通常含有其他成分。我们小组和其他人的最新证据表明,与其他配方相比,补充 DHA、EPA 和 GLA(“Omega 3-6”)的鱼油和琉璃苣油组合特别有前景。在启动严格、全面的疗效试验之前,迫切需要评估 Omega 3-6 的最佳剂量以及与 ASD 症状相关的生理相关生物特征的变化。我们的目标是评估较高剂量的 Omega 3-6 对预先指定的生物特征的影响 我们的总体假设是,Omega 3-6 的最佳剂量将以与 ASD 相关行为的改善相关的方式改变生物特征。该提案的 R61 阶段将测试以下假设:Omega 3-6 将使一种或多种炎症标志物 IL-1β、IL-2 和 IFNγ 产生临床显着降低(改善),并且我们的更高剂量将证明生物利用度、安全性和耐受性。该提案的 R33 阶段将测试以下假设:对生物特征的影响与 Omega 3-6 剂量相关,可以在新的患者样本中复制,并且关键炎症标志物的变化与补充后的核心 ASD 症状相关。完成这个拟议的两阶段项目后,我们希望确定 Omega 3-6 对炎症以及随后对儿童 ASD 症状发挥作用的最佳剂量范围。这些结果预计将产生重要的积极影响,为评估 Omega 3-6 对 ASD 症状改善效果的全面功效试验奠定必要的基础。
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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:
- 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.
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Sarah Keim其他文献
Sarah Keim的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Sarah Keim', 18)}}的其他基金
Environmental Influences on Child Health Outcomes (ECHO) and Pregnancy in Ohio
俄亥俄州环境对儿童健康结果 (ECHO) 和怀孕的影响
- 批准号:
10746498 - 财政年份:2023
- 资助金额:
$ 40.05万 - 项目类别:
Long-term Effects and Safety of DHA Supplementation in Toddlerhood for Children born Preterm
学步期补充 DHA 对早产儿的长期影响和安全性
- 批准号:
10226056 - 财政年份:2020
- 资助金额:
$ 40.05万 - 项目类别:
Long-term Effects and Safety of DHA Supplementation in Toddlerhood for Children born Preterm
学步期补充 DHA 对早产儿的长期影响和安全性
- 批准号:
10650351 - 财政年份:2020
- 资助金额:
$ 40.05万 - 项目类别:
Long-term Effects and Safety of DHA Supplementation in Toddlerhood for Children born Preterm - Administrative Supplement
学步期补充 DHA 对早产儿的长期影响和安全性 - 行政补充
- 批准号:
10727669 - 财政年份:2020
- 资助金额:
$ 40.05万 - 项目类别:
Long-term Effects and Safety of DHA Supplementation in Toddlerhood for Children born Preterm
学步期补充 DHA 对早产儿的长期影响和安全性
- 批准号:
10012322 - 财政年份:2020
- 资助金额:
$ 40.05万 - 项目类别:
Long-term Effects and Safety of DHA Supplementation in Toddlerhood for Children born Preterm
学步期补充 DHA 对早产儿的长期影响和安全性
- 批准号:
10443726 - 财政年份:2020
- 资助金额:
$ 40.05万 - 项目类别:
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:
10222888 - 财政年份:2017
- 资助金额:
$ 40.05万 - 项目类别:
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:
10266170 - 财政年份:2017
- 资助金额:
$ 40.05万 - 项目类别:
The Development of Early Childhood Obesity in Children Born Preterm
早产儿早期肥胖的发展
- 批准号:
9112267 - 财政年份:2016
- 资助金额:
$ 40.05万 - 项目类别:
Development and Evaluation of New Breastfeeding Questions Applicable to Multiple National Surveys
适用于多项全国调查的新母乳喂养问题的开发和评估
- 批准号:
9159393 - 财政年份:2016
- 资助金额:
$ 40.05万 - 项目类别:
相似海外基金
Hormone therapy, age of menopause, previous parity, and APOE genotype affect cognition in aging humans.
激素治疗、绝经年龄、既往产次和 APOE 基因型会影响老年人的认知。
- 批准号:
495182 - 财政年份:2023
- 资助金额:
$ 40.05万 - 项目类别:
Investigating how alternative splicing processes affect cartilage biology from development to old age
研究选择性剪接过程如何影响从发育到老年的软骨生物学
- 批准号:
2601817 - 财政年份:2021
- 资助金额:
$ 40.05万 - 项目类别:
Studentship
RAPID: Coronavirus Risk Communication: How Age and Communication Format Affect Risk Perception and Behaviors
RAPID:冠状病毒风险沟通:年龄和沟通方式如何影响风险认知和行为
- 批准号:
2029039 - 财政年份:2020
- 资助金额:
$ 40.05万 - 项目类别:
Standard Grant
Neighborhood and Parent Variables Affect Low-Income Preschool Age Child Physical Activity
社区和家长变量影响低收入学龄前儿童的身体活动
- 批准号:
9888417 - 财政年份:2019
- 资助金额:
$ 40.05万 - 项目类别:
The affect of Age related hearing loss for cognitive function
年龄相关性听力损失对认知功能的影响
- 批准号:
17K11318 - 财政年份:2017
- 资助金额:
$ 40.05万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Affect regulation and Beta Amyloid: Maturational Factors in Aging and Age-Related Pathology
影响调节和 β 淀粉样蛋白:衰老和年龄相关病理学中的成熟因素
- 批准号:
9320090 - 财政年份:2017
- 资助金额:
$ 40.05万 - 项目类别:
Affect regulation and Beta Amyloid: Maturational Factors in Aging and Age-Related Pathology
影响调节和 β 淀粉样蛋白:衰老和年龄相关病理学中的成熟因素
- 批准号:
10166936 - 财政年份:2017
- 资助金额:
$ 40.05万 - 项目类别:
Affect regulation and Beta Amyloid: Maturational Factors in Aging and Age-Related Pathology
影响调节和 β 淀粉样蛋白:衰老和年龄相关病理学中的成熟因素
- 批准号:
9761593 - 财政年份:2017
- 资助金额:
$ 40.05万 - 项目类别:
How age dependent molecular changes in T follicular helper cells affect their function
滤泡辅助 T 细胞的年龄依赖性分子变化如何影响其功能
- 批准号:
BB/M50306X/1 - 财政年份:2014
- 资助金额:
$ 40.05万 - 项目类别:
Training Grant
Inflamm-aging: What do we know about the effect of inflammation on HIV treatment and disease as we age, and how does this affect our search for a Cure?
炎症衰老:随着年龄的增长,我们对炎症对艾滋病毒治疗和疾病的影响了解多少?这对我们寻找治愈方法有何影响?
- 批准号:
288272 - 财政年份:2013
- 资助金额:
$ 40.05万 - 项目类别:
Miscellaneous Programs