NCT02541929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

June 30, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

September 2, 2015

Last Update Submit

March 29, 2020

Conditions

Brain Health

Keywords

Alzheimer's diseaseDocosahexaenoic acidbrain healthmemoryfish oilcognitionDHAomega 3 fatty acidbrain

Outcome Measures

Primary Outcomes (1)

  • changes in DHA levels in the CSF following dietary DHA supplementation

    6 months

Secondary Outcomes (1)

  • Brain MRI

    6 months and 1 year

Study Arms (2)

DHA

EXPERIMENTAL

DHA (2grams/day) for 26 weeks

Dietary Supplement: Docosahexaenoic acid

placebo

PLACEBO COMPARATOR

placebo (4 capsules per day) for 26 weeks

Dietary Supplement: Docosahexaenoic acid

Interventions

Docosahexaenoic acidDIETARY_SUPPLEMENT
DHAplacebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Related Publications (2)

  • Bantugan MA, Xian H, Solomon V, Lee M, Cai Z, Wang S, Duro MV, Kerman BE, Fonteh A, Meuret C, Li M, Braskie MN, McIntire LBJ, Jurin L, Oberlin S, Evans J, Davis R, Mack WJ, Abdullah L, Yassine HN. Associations of ApoE4 status and DHA supplementation on plasma and CSF lipid profiles and entorhinal cortex thickness. J Lipid Res. 2023 Jun;64(6):100354. doi: 10.1016/j.jlr.2023.100354. Epub 2023 Mar 22.

    PMID: 36958720DERIVED

  • Arellanes IC, Choe N, Solomon V, He X, Kavin B, Martinez AE, Kono N, Buennagel DP, Hazra N, Kim G, D'Orazio LM, McCleary C, Sagare A, Zlokovic BV, Hodis HN, Mack WJ, Chui HC, Harrington MG, Braskie MN, Schneider LS, Yassine HN. Brain delivery of supplemental docosahexaenoic acid (DHA): A randomized placebo-controlled clinical trial. EBioMedicine. 2020 Sep;59:102883. doi: 10.1016/j.ebiom.2020.102883. Epub 2020 Jul 17.

    PMID: 32690472DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Hussein N. Yassine, MD

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 4, 2015

Study Start

June 30, 2016

Primary Completion

November 30, 2018

Study Completion

September 30, 2019

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

US(1)