- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- USC Keck School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: DHA
DHA (2grams/day) for 26 weeks
|
|
PLACEBO_COMPARATOR: placebo
placebo (4 capsules per day) for 26 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in DHA levels in the CSF following dietary DHA supplementation
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain MRI
Time Frame: 6 months and 1 year
|
Structural and functional connectivity
|
6 months and 1 year
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HS-14-00864
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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