Clinical trial NCT02541929: Fish Oil Brain Delivery Study
Official title: Fish Oil Brain Delivery Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Brain Health
Keywords: Alzheimer's disease
Docosahexaenoic acid
brain health
memory
fish oil
cognition
DHA
omega 3 fatty acid
brain
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2015-09-04
Enrollment: 31
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: changes in DHA levels in the CSF following dietary DHA supplementation
timeFrame: 6 months
Secondary outcomes:
measure: Brain MRI
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
Study officials:
References:
citation: Arellanes IC, Choe N, Solomon V, He X, Kavin B, Martinez AE, Kono N, Buennagel DP, Hazra N, Kim G, D'Orazio LM, McCleary C, Sagare A, Zlokovic BV, Hodis HN, Mack WJ, Chui HC, Harrington MG, Braskie MN, Schneider LS, Yassine HN. Brain delivery of supplemental docosahexaenoic acid (DHA): A randomized placebo-controlled clinical trial. EBioMedicine. 2020 Sep;59:102883. doi: 10.1016/j.ebiom.2020.102883. Epub 2020 Jul 17.