The Combination of Citicoline and Omega-3 on Attention in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Accuracy (percent correct) on an attention task (Conners continuous performance test3)
研究概览
简要总结
The goal of this study is to determine the effects of Citicoline plus Omega-3 or Omega-3 alone versus placebo on attention in non-demented healthy older adults.
详细描述
This study is a randomized, double-blind, placebo-controlled trial. The investigators hypothesize that supplementation of Citicoline plus Omega-3 will improve attention in healthy adults age 55 years and older, compared to placebo. The study is designed as 3-arm, parallel group study comparing placebo, Omega-3 only, and Citicoline plus Omega-3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 55 years or older
- •If female, must be post-menopausal
- •Non-demented
- •Not depressed
- •General health status that will not interfere with the participant's ability to complete the study
- •No history of neurological disorder
- •Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator
- •Sufficient English language skills to complete all testing
排除标准
- •Alzheimer's, Dementia or other neurological disease
- •Fish intake of 6 ounce serving once a week 3 months prior to enrollment; Omega-3 supplement intake (e.g. fish oil capsules, cod liver oil, or flaxseed oil) less than 3 months prior to enrollment.
- •Citicoline supplementation 3 months prior to enrollment
- •Prescriptions medications:
- •Anticoagulation therapy: Vitamin K antagonist: warfarin (Coumadin, jantoven), Factor Xa inhibitors: rivaroxaban (xarelto), fondaparinux (arixtra), dibigatran (pradaxa), apixaban (eliquis); Low molecular weight heparins: dalteparin (fragmin), enoxaparin (lovenox)
- •Dementia medications (e.g. anticholinesterase inhibitors, memantine)
- •Diagnosis of Adult Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD) and/or taking stimulants (e.g. dextroamphetamine sulfate, methylphenidate HCL, dextroamphetamine Sulf-Saccharate)
- •Body Mass Index > 30
- •Enrollment in another treatment study
研究组 & 干预措施
Omega-3
Intervention: Dietary Supplement: Omega-3 supplement
干预措施: Omega-3 supplement (Dietary Supplement)
Placebo
Intervention: Dietary Supplement: Placebo supplement
干预措施: Placebo supplement (Dietary Supplement)
Cognizin and Omega-3
Intervention: Dietary Supplement: Citicoline and Omega-3 supplement
干预措施: Citicoline and Omega-3 supplement (Dietary Supplement)
结局指标
主要结局
Accuracy (percent correct) on an attention task (Conners continuous performance test3)
时间窗: 16 weeks
次要结局
- Scores of Neuropsychological test battery from the Uniform Data Set(16 weeks)