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

NCT00014027 | Completed Phase 1

• 2 other identifiers: 01014101-AA-0141
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Omega-3 Fatty Acids; Cerebrospinal Fluid; Neurotransmitters; Cardiovascular; Reactivity; Healthy Volunteer; Lumbar Puncture; MRI

Interventions

Docosahexaenoic acid (DHA) DRUG

Eicosapentaenoic acid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A primary diagnosis of alcohol dependence within the last three months.
• Male or female research participants with a Coccaro Lifetime History of Aggression score of 20 or more.
• Reported consumption of seafood no greater than twice per week.
• Age of 18 years or older.
• Must have been sober for 21-60 days.
• Laboratory history and physical exam findings that are without significant abnormalities (significant abnormality would include laboratory deviations that require medical intervention or that indicate a major medical disorder).
• EKG and chest X-ray are without clinically significant abnormalities as determined by the physician interpreting the studies.
• Educational level and degree of understanding that is sufficient to provide informed consent, sign the consent forms and to allow for clear and intelligent communication between research participant, investigators and staff.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Adams PB, Lawson S, Sanigorski A, Sinclair AJ. Arachidonic acid to eicosapentaenoic acid ratio in blood correlates positively with clinical symptoms of depression. Lipids. 1996 Mar;31 Suppl:S157-61. doi: 10.1007/BF02637069.

  PMID: 8729112 BACKGROUND

• Apter A, Plutchik R, van Praag HM. Anxiety, impulsivity and depressed mood in relation to suicidal and violent behavior. Acta Psychiatr Scand. 1993 Jan;87(1):1-5. doi: 10.1111/j.1600-0447.1993.tb03321.x.

  PMID: 8424318 BACKGROUND

• Akselrod S, Gordon D, Madwed JB, Snidman NC, Shannon DC, Cohen RJ. Hemodynamic regulation: investigation by spectral analysis. Am J Physiol. 1985 Oct;249(4 Pt 2):H867-75. doi: 10.1152/ajpheart.1985.249.4.H867.

  PMID: 4051021 BACKGROUND

MeSH Terms

Interventions

Docosahexaenoic Acids; Eicosapentaenoic Acid

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Eicosanoids

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 7, 2001
• First Posted: April 9, 2001
• Study Start: April 4, 2001
• Primary Completion: April 11, 2008
• Study Completion: April 11, 2008
• Last Updated: July 2, 2017

Record last verified: 2010-07-13

Locations

US (1)