Fish Oil Brain Delivery Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02541929 |
Recruitment Status :
Completed
First Posted : September 4, 2015
Last Update Posted : March 31, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Health | Dietary Supplement: Docosahexaenoic acid | Phase 2 Phase 3 |
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Fish Oil Brain Delivery Study |
Actual Study Start Date : | June 30, 2016 |
Actual Primary Completion Date : | November 30, 2018 |
Actual Study Completion Date : | September 30, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: DHA
DHA (2grams/day) for 26 weeks
|
Dietary Supplement: Docosahexaenoic acid |
Placebo Comparator: placebo
placebo (4 capsules per day) for 26 weeks
|
Dietary Supplement: Docosahexaenoic acid |
- changes in DHA levels in the CSF following dietary DHA supplementation [ Time Frame: 6 months ]
- Brain MRI [ Time Frame: 6 months and 1 year ]Structural and functional connectivity

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541929
United States, California | |
USC Keck School of Medicine | |
Los Angeles, California, United States, 90033 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hussein Yassine, Dr. Hussein N. Yassine, MD, University of Southern California |
ClinicalTrials.gov Identifier: | NCT02541929 |
Other Study ID Numbers: |
HS-14-00864 |
First Posted: | September 4, 2015 Key Record Dates |
Last Update Posted: | March 31, 2020 |
Last Verified: | March 2020 |
Alzheimer's disease Docosahexaenoic acid brain health memory fish oil |
cognition DHA omega 3 fatty acid brain |