Fish Oil Brain Delivery Study

University of Southern California

Status and phase: Completed; Phase 3; Phase 2

Conditions: Brain Health

Treatments: Dietary Supplement: Docosahexaenoic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02541929

HS-14-00864

Details and patient eligibility

About

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.

Full description

• 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.

Enrollment: 31 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

1. Current smokers (or a recent history of smoking within less than 5 years),
2. Having a history of cardiovascular disease defined by a prior heart attack, coronary bypass or percutaneous luminal angioplasty, kidney failure or blindness.
3. a diagnosis of cancer in the past 6 months, uncontrolled hyper- or hypothyroidism
4. Taking anti-coagulants such as warfarin
5. Anyone consuming n-3 PUFA capsules for the last 3 months.
6. regular exercisers (>5 X30min of aerobic exercise per week),
7. 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)
8. 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

DHA

Experimental group

Description:

DHA (2grams/day) for 26 weeks

Treatment:

Dietary Supplement: Docosahexaenoic acid

placebo

Placebo Comparator group

Description:

placebo (4 capsules per day) for 26 weeks

Treatment:

Dietary Supplement: Docosahexaenoic acid