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Completed

NCT Number: NCT02541929

Fish Oil Brain Delivery Study

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

USC Keck School of Medicine

Los Angeles, California, 90033, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Docosahexaenoic acid

Dietary Supplement

Primary outcomes

  1. changes in DHA levels in the CSF following dietary DHA supplementation

    Time frame: 6 months

Secondary outcomes

  1. Brain MRI

    Time frame: 6 months and 1 year

    Structural and functional connectivity

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Alzheimer's Association

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 4, 2015
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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