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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
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Hussein Yassine, University of Southern California

Study Description
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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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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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


Locations
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United States, California
USC Keck School of Medicine
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Alzheimer's Association
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
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