NCT02541929已完成2 期
Fish Oil Brain Delivery Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- changes in DHA levels in the CSF following dietary DHA supplementation
研究概览
简要总结
Docosahexaenoic acid (DHA) is an essential omega-3 fish oil. DHA is critical to the structure and function of brain cells.
DHA fish oil has been shown to be beneficial in cognition in several animal studies; however, this effect in human studies is not clear. It is not known how much dietary fish oil can get into the human brain. Thus, exploring fish oil delivery in human brains is critical for designing appropriate interventions.
详细描述
- The investigators goal is to study how different people deliver DHA to the brain.
- The study will only require two visits six months apart and involve taking DHA during these 6 months.
- Participants will receive DHA supplements for the study duration and a compensation for each study visit.
- Blood and cerebrospinal fluid levels of DHA will be measured before and after taking DHA.
- Brain imaging by MRI will be obtained at baseline and at conclusion of study
- This study will help us learn how much of the ingested DHA goes to the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, 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
- •ages 55 and above
- •at risk of Alzheimer's disease such as family history of dementia
- •women have to be postmenopausal
排除标准
- •Current smokers (or a recent history of smoking within less than 5 years),
- •Having a history of cardiovascular disease defined by a prior heart attack, coronary bypass or percutaneous luminal angioplasty, kidney failure or blindness.
- •a diagnosis of cancer in the past 6 months, uncontrolled hyper- or hypothyroidism
- •Taking anti-coagulants such as warfarin
- •Anyone consuming n-3 PUFA capsules for the last 3 months.
- •regular exercisers (>5 X30min of aerobic exercise per week),
- •heavy drinkers (>30 units of alcohol per week). One unit of alcohol is about equal to: half a pint of ordinary strength beer, lager or cider (3-4% alcohol by volume); or. a small pub measure (25 ml) of spirits (40% alcohol by volume); or. a standard pub measure (50 ml) of fortified wine such as sherry or port (20% alcohol by volume)
- •If participants have scores that lie 2 SD outside the means of the neuropsychiatry tests administered, they will have mild cognitive impairment. Participant's with mild cognitive impairment are excluded from this study.
结局指标
主要结局
changes in DHA levels in the CSF following dietary DHA supplementation
时间窗: 6 months
次要结局
- Brain MRI(6 months and 1 year)
研究者
Hussein Yassine
Dr. Hussein N. Yassine, MD
University of Southern California
研究点 (2)
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