Citicoline Effects on Cortical Membrane Structure and Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- b-NTP concentrations in the ACC by 31P-MRS
研究概览
简要总结
The goal of this project is to determine the effects of 6-week dietary supplementation with one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy middle-aged adults.
详细描述
To determine the effect of citicoline supplementation on cortical structure and function in healthy middle-aged adults. Test 1: The effect of citicoline (500 mg/d) compared with placebo on event-related anterior cingulate cortex (ACC) activation during sustained attention by fMRI. Test 2: The effect of citicoline (500 mg/d) compared with placebo on reaction time and increasing accuracy on the sustained attention task (CPT-IP). Test 3: The effect of citicoline compared with placebo on phosphodiester (PDE) and b-NTP levels in the ACC by 31P-MRS. Test 4: ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS) following high-dose citicoline (500 mg/d) compared with placebo at Week 3. Test 5: The effect of low-dose citicoline (250 mg/d) compared with placebo on an ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS). Test 6: Among all subjects (n=60), the relationship between baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels and ACC activation, ACC PDE levels, or the effects of citicoline.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent;
- •Ages 40-60 years old;
- •Right handed.
- •If female, not pregnant (as determined by a positive pregnancy test); and agrees to use one of the following methods of birth control: abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive;
排除标准
- •Contraindication to an MRI scan (i.e., braces, claustrophobia, pacemaker etc);
- •A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy);
- •Body mass index (BMI) ≥ 30;
- •An IQ <75 and >130;
- •A positive urine drug test (nicotine dependence is permitted);
- •Personal history of a DSM-5 Axis I psychiatric disorder;
- •Requiring treatment with a drug which might obscure the action of the study treatment.
结局指标
主要结局
b-NTP concentrations in the ACC by 31P-MRS
时间窗: 6 weeks
Phosphodiester (PDE) concentrations in the ACC by 31P-MRS
时间窗: 6 weeks
次要结局
- Blood oxygenation level-dependent signal in the ACC during sustained attention by fMRI(6 weeks)
- Reaction time (ms) on an attention task (CPT-IP)(6 weeks)
- Accuracy (percent correct) on an attention task (CPT-IP)(6 weeks)