ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02541929
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : March 30, 2017
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Hussein Yassine, University of Southern California

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.


Condition or disease Intervention/treatment Phase
Brain Health Dietary Supplement: Docosahexaenoic acid Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 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
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

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



Primary Outcome Measures :
  1. changes in DHA levels in the CSF following dietary DHA supplementation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Brain MRI [ Time Frame: 6 months and 1 year ]
    Structural and functional connectivity



Information from the National Library of Medicine

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:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages 40 and above
  • at risk of Alzheimer's disease such as family history of dementia
  • women have to be post menopausal

Exclusion Criteria:

  • current intake of fish oil or omega-3 supplements
  • history of prior heart attack, coronary bypass or percutaneous luminal angioplasty or strokes

Information from the National Library of Medicine

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


Contacts
Contact: Hussein Yassine, MD 323-442-1909

Locations
United States, California
USC Keck School of Medicine Recruiting
Los Angeles, California, United States, 90033
Contact: Hussein Yassine    323-489-4896    fishoilforbrain@gmail.com   
Sponsors and Collaborators
University of Southern California
Alzheimer's Association

Additional Information:
Responsible Party: Hussein Yassine, Dr. Hussein N. Yassine, MD, University of Southern California
ClinicalTrials.gov Identifier: NCT02541929     History of Changes
Other Study ID Numbers: HS-14-00864
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by Hussein Yassine, University of Southern California:
Alzheimer's disease
Docosahexaenoic acid
brain health
memory
fish oil
cognition
DHA
omega 3 fatty acid
brain