Skip to content

Fish Oil Brain Delivery Study

Fish Oil Brain Delivery Study

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02541929
Enrollment
31
Registered
2015-09-04
Start date
2016-06-30
Completion date
2019-09-30
Last updated
2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Health

Keywords

Alzheimer's disease, Docosahexaenoic acid, brain health, memory, fish oil, cognition, DHA, omega 3 fatty acid, brain

Brief summary

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

* 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.

Interventions

DIETARY_SUPPLEMENTDocosahexaenoic acid

Sponsors

Alzheimer's Association
CollaboratorOTHER
University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
changes in DHA levels in the CSF following dietary DHA supplementation6 months

Secondary

MeasureTime frameDescription
Brain MRI6 months and 1 yearStructural and functional connectivity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026