Fish Oil Brain Delivery Study | NCT02541929

Studies
Fish Oil Brain Delivery Study

NCT02541929

Sponsor

University of Southern California

Status

Completed

Last Update Posted

Mar 31, 2020Actual

Enrollment

31Actual

Phase

Phase 2Phase 3

Conditions

Brain Health

Interventions

Docosahexaenoic acid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2016Actual

Primary Completion Date

Nov 30, 2018Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Sep 2, 2015

First Submission Date that Met QC Criteria

Sep 3, 2015

First Posted Date

Sep 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2020

Last Update Posted Date

Mar 31, 2020Actual

Name	Class
Alzheimer's Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Docosahexaenoic acid	Dietary Supplement		DHA placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
USC Keck School of Medicine		Los Angeles	California	90033	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36958720	Derived	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.
32690472

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats