Fish Oil Brain Delivery Study

Phase 2

Completed

• Conditions: Brain Health
• Interventions: Dietary Supplement: Docosahexaenoic acid

• Registration Number: NCT02541929
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-04
• Study Start: 2016-06-30
• Primary Completion: 2018-11-30
• Study Completion: 2019-09-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-29
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• ages 55 and above
• at risk of Alzheimer's disease such as family history of dementia
• women have to be postmenopausal

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo	Docosahexaenoic acid	placebo (4 capsules per day) for 26 weeks
DHA	Docosahexaenoic acid	DHA (2grams/day) for 26 weeks

Primary Outcome Measures

Name	Time	Method
changes in DHA levels in the CSF following dietary DHA supplementation	6 months

Secondary Outcome Measures

Name	Time	Method
Brain MRI	6 months and 1 year	Structural and functional connectivity

Trial Locations

Locations (1)

USC Keck School of Medicine; 🇺🇸 Los Angeles, California, United States