Lutein and Multiple Sclerosis Experimental Study (LuMES)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Macular Pigment Optical Density
研究概览
简要总结
The central hypothesis is that lutein supplementation will improve MPOD and cognition. Accordingly, the specific aims are to 1) to determine the process feasibility associated with participating in 4-month lutein supplementation trial; and 2) to investigate the scientific feasibility of 4-month daily lutein supplementation on biological markers of lutein status and cognitive function among persons with MS.
详细描述
A two-group parallel design will be employed whereby participants will be randomly assigned to one of 2 groups. The supplementation doses 20mg/d (Group 1), and placebo (Group 2) will be consumed daily by the participant for a 4-month period. Pre-test and follow-up measures of lutein status and cognitive function will be assessed at baseline and at 4-month follow-up via laboratory visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-64.9 years
- •Self-reported relapsing-remitting MS (RRMS) diagnosis
- •Expanded Disability Status Scale (EDSS) score between 0-3.5
- •Macular Pigment Optical Density at baseline (MPOD ≤0.35)
- •Score ≤55 during the Symbol Digit Modalities Test (SDMT)
- •20/20 or corrected vision
- •No presence of color blindness
- •No history of age-related macular degeneration
- •No history of epileptic seizures
排除标准
- •Under 18 years or over 64.9 years
- •MS diagnosis other than RRMS
- •Pregnancy
- •Uncorrected vision
- •Presence of color blindness
- •PDDS score of 7 or more
- •Prior diagnosis of age-related macular degeneration
- •History of epileptic seizures
研究组 & 干预措施
Safflower Oil
干预措施: Placebo (Dietary Supplement)
Lutein
干预措施: Lutein (Dietary Supplement)
结局指标
主要结局
Macular Pigment Optical Density
时间窗: 4 months (baseline vs. follow-up)
Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer
Attentional Accuracy
时间窗: 4 months (baseline vs. follow-up)
Changes in accuracy (%) between groups using a computerized flanker task
Attentional Reaction Time
时间窗: 4 months (baseline vs. follow-up)
Changes in reaction time (ms) between groups using a computerized flanker task
Attentional Resource Allocation
时间窗: 4 months (baseline vs. follow-up)
Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task
Attentional Processing Speed
时间窗: 4 months (baseline vs. follow-up)
Changes in P3 event related potential latency (ms) between groups using a computerized flanker task
次要结局
未报告次要终点
研究者
Naiman Khan
Assistant Professor
University of Illinois at Urbana-Champaign