Fish Oil Brain Delivery Study

Brain Health Clinical Trial

Official title:

Fish Oil Brain Delivery Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541929
• Other study ID #: HS-14-00864
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 30, 2016
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 30, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Health

Intervention

Dietary Supplement:
• Docosahexaenoic acid

Locations

Country	Name	City	State
United States	USC Keck School of Medicine	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Alzheimer's Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in DHA levels in the CSF following dietary DHA supplementation		6 months
Secondary	Brain MRI	Structural and functional connectivity	6 months and 1 year

External Links

•   Yassine Lab Website