Fish Oil Brain Delivery Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Fish Oil Brain Delivery Study

Conditions
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Brain Health

Intervention / Treatment
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* Dietary Supplement: Docosahexaenoic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 55 and above at risk of Alzheimer's disease such as family history of dementia women have to be postmenopausal Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA<br>DHA (2grams/day) for 26 weeks | Dietary Supplement: Docosahexaenoic acid<br> <br> |
| Placebo Comparator: placebo<br>placebo (4 capsules per day) for 26 weeks | Dietary Supplement: Docosahexaenoic acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in DHA levels in the CSF following dietary DHA supplementation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain MRI | Structural and functional connectivity | 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, Docosahexaenoic acid, brain health, memory, fish oil, cognition, DHA, omega 3 fatty acid, brain