Effect of Polyunsaturated Fatty Acids on Cardiovascular and Motor Responses Under Stress

Completed · Phase 1

Conditions studied: Healthy

In brief

This research study is designed to find out if increasing the dietary intake of polyunsaturated fats improves concentration, motor skills and cardiovascular responses under stress. These polyunsaturated fats may also change the chemicals in the brain that control these responses. Specifically, these polyunsaturated fats may raise brain levels of neurotransmitters called dopamine and serotonin. Polyunsaturated fats are important for improving the function of both the brain and the heart. People cannot make these polyunsaturated fats and they can only be obtained from the oils that we eat. For three months subjects will take 8 capsules a day that contain either corn oils flavored with fish oils or fish oil that taste a little like corn oils. Subjects will not be told which oils we expect to work better. An initial evaluation will determine if subjects fit the criteria necessary to enter the study. A battery of tests will be conducted twice, once before starting the capsules and again after three months of taking the capsules. These batteries of tests will include an MRI of the head, paper and pencil tests to evaluate changes in mood, and tests of concentration and motor skills and cardiovascular responses under stress. Two lumbar punctures will be performed to collect cerebrospinal fluid so that changes in neurotransmitters can be evaluated. Subjects will be on a no seafood diet to equalize their dietary intake of polyunsaturated fatty acids. Subjects will be expected to complete all parts of this study.

Key facts

Study ID

NCT00014027

Run by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

People needed

97

Starts

2001-04-04

Expected to finish

2008-04-11

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Lifetime history of an axis I psychiatric disorders specifically psychotic, schizophrenic, bipolar affective disorder type I or eating disorders or premenstrual phase dysphoric disorder. Major depression, depressive disorder NOS, panic and other anxiety disorders are not exclusionary. Axis II personality disorders are not exclusionary.
• Major medical disorders or major neurological disorders.
• Determination by the Principal Investigator that the subject's use of prescription or illicit drugs within the last six months will interfere with the dependent endpoints of the study.
• Regular use of prescription medications with psychotropic effects including side effects or medications that modify lipid metabolism, within the last month. Use of NSAIDS, aspirin or Tylenol not more than five times total per week, will be allowed.
• Current psychotherapy to reduce aggression or depression.
• Extensive use of home remedies, vitamins or nutritional supplements within three months. Use of multi-vitamins one time per day will be allowed.
• Pacemaker or other metal implants, which might be a contraindication for a MRI, scan.
• Laboratory tests which indicate presence of the HIV.
• Pregnancy.
• Allergy to fish or seafood.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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