NCT00662142已完成3 期
Effect of 8-Week Dietary DHA Supplementation on Cerebral Blood Flow and Metabolic Function
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- performance on sustained attention task (CPT-IP)
研究概览
简要总结
The goal of this study is to determine if 8-week dietary treatment with the omega-3 fatty acid docosahexaenoic acid (DHA) improves attention performance and associated cortical activity and metabolism in 8 - 10 year old males that were not breast-fed during infancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects between the ages of 8 - 10 years.
- •Not breast-fed during infancy
- •Right hand dominant
- •Attending school at appropriate grade level
- •Normal body-mass index (BMI)
- •Ability and willingness to provide assent and informed, written consent from at least one biological parent.
- •Present with biological parent
- •No current general medical or psychiatric illness.
- •Medication free.
- •Normal intelligence as assessed by the Kaufman Brief Intelligence Test.
- •Willingness to maintain current dietary habits.
排除标准
- •Inability or unwillingness to provide consent.
- •Antecedent or concurrent serious medical illness.
- •A lifetime history of any significant axis I psychiatric disorder ( i.e. bipolar disorder, schizophrenia)
- •Patients who have received any psychoactive medications, current and lifetime.
- •Clinically unstable medical disease, including cardiovascular, hepatic insufficiency, severe renal impairment, gastrointestinal, pulmonary, metabolic, endocrine, obesity or other systemic disease.
- •History of seizures, excluding febrile seizures in childhood.
- •Patients requiring treatment with any drug which might obscure the action of study the study treatment.
- •Less than normal intelligence.
- •Cerebral aneurysm clip
- •Cochlear implant
- •Metal fragments lodged within the eye
- •Claustrophobia
- •Necessity of sedation (no sedation will be given).
- •History of loss of consciousness > 10 minutes in duration
研究组 & 干预措施
1
Experimental
DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio
干预措施: docosahexaenoic acid (Dietary Supplement)
结局指标
主要结局
performance on sustained attention task (CPT-IP)
时间窗: 8 weeks
次要结局
- fMRI activation of prefrontal and frontal cortical regions during performance of an attention task (CPT-IP)(8 weeks)
- NAA concentrations(8 weeks)
研究者
研究点 (1)
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