Fish Oil Brain Delivery Study

March 29, 2020 updated by: Hussein Yassine, University of Southern California

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

31

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90033
        • USC Keck School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DHA
DHA (2grams/day) for 26 weeks
PLACEBO_COMPARATOR: placebo
placebo (4 capsules per day) for 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in DHA levels in the CSF following dietary DHA supplementation
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain MRI
Time Frame: 6 months and 1 year
Structural and functional connectivity
6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2016

Primary Completion (ACTUAL)

November 30, 2018

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (ESTIMATE)

September 4, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 29, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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