NCT00278135已完成不适用
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in the Elderly
DSM Nutritional Products, Inc.27 个研究点 分布在 1 个国家目标入组 485 人开始时间: 2005年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 485
- 试验地点
- 27
- 主要终点
- Determine the effects of DHA, a nutritional supplement (900 mg/d) on improving cognitive functions (i.e. working memory, memory retention, attention, and executive function) in healthy elderly subjects at 24 weeks
研究概览
简要总结
The purpose of this study is to investigate the effect of docosahexaenoic acid (DHA, 22:6n-3) in improving cognitive functions in subjects with age-related cognitive decline. DHA is a long chain omega-3 fatty acid (LC-PUFA) that plays an important role in neural and visual development and cardiovascular health.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, aged 55 or greater.
- •Have a subjective memory complaint and have a Logical Memory subtest (of the Wechsler Memory Scale - III [WMS-III]) raw score one standard deviation or greater below the mean of a younger population.
- •Have the ability to understand the requirements of the study; be willing to provide written informed consent; and agree to abide by the study restrictions and return for the required assessments.
- •If taking non-prohibited medication, be on a stable drug regimen (in prior 3 months).
排除标准
- •Have a screening Mini-Mental State Examination (MMSE) <
- •Consume greater than 200 mg/day DHA as assessed on a DHA Food Frequency Questionnaire in the prior 2 months to screening.
- •Use nutritional fish oil, flaxseed oil, omega-3 supplements, or huperzine in the prior 2 months to screening.
- •Use acetylcholinesterase inhibitors or memantine in the prior 2 months to screening.
- •Use major anti-psychotics or major anti-depressants.
- •Use lipase inhibitors such as Xenical® (orlistat).
- •History of major medical conditions including ischemic stroke, head trauma with loss of consciousness, epilepsy, psychosis, vascular dementia, depression (Geriatric Depression [15-item] > 5), myocardial infarction (within 1 year), uncontrolled diabetes, or blindness.
- •History of major surgery within the past 6 months.
- •Current use or history of drug and/or alcohol abuse within 5 years.
- •Administration of any investigational product within the past 30 days.
- •Inability to swallow capsules.
结局指标
主要结局
Determine the effects of DHA, a nutritional supplement (900 mg/d) on improving cognitive functions (i.e. working memory, memory retention, attention, and executive function) in healthy elderly subjects at 24 weeks
时间窗: 24 weeks
次要结局
- Effects of DHA on visual acuity, levels of plasma phospholipids, and evaluating the safety and tolerability of the DHA dose administered(24 weeks)
- The study will include a screening period, baseline, and 24 week treatment period.
研究者
研究点 (27)
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