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Evaluating the Effects of Omega-3 Fatty Acids on Heart Disease and Behavior

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00663871
First received: April 18, 2008
Last updated: July 5, 2012
Last verified: July 2012

April 18, 2008
July 5, 2012
June 2008
April 2012   (final data collection date for primary outcome measure)
Circulating markers of systemic inflammation; autonomic control of heart rate; self-report, laboratory-based, and interview-based measures of affect, hostility, anger, impulsivity, and aggression [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
Circulating markers of systemic inflammation; self-report, laboratory-based, and interview-based measures of affect, hostility, anger, impulsivity, and aggression [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00663871 on ClinicalTrials.gov Archive Site
  • Cognitive performance; structural and functional brain imaging post supplementation [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • Moderation of effects of fish oil on inflammatory markers by select genetic polymorphisms [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • Cognitive performance [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • Moderation of effects of fish oil on inflammatory markers by select genetic polymorphisms [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluating the Effects of Omega-3 Fatty Acids on Heart Disease and Behavior
BioBehavioral Studies of Cardiovascular Disease

Omega-3 fatty acids are a certain kind of fish fat that has recently been shown to have health benefits. This study will examine the effectiveness of fish oil supplementation for reducing the early signs of heart disease risk and for improving mood, impulsivity, and anger levels.

Cardiovascular disease (CVD) is a broad term that includes diseases that affect the heart and blood vessels, including coronary heart disease, heart failure, high blood pressure, and stroke. CVD is the leading cause of death in the United States, resulting in 700,000 deaths each year. Preliminary research has shown that increased consumption of fish, specifically the omega-3 fatty acids found in fish oil, has beneficial effects in people with CVD. Fish oil may also have positive effects on the psychological health and well-being of people with psychiatric disorders. However, more research is needed to confirm the positive physical and psychological effects of fish oil in healthy adults. The purpose of this study is to evaluate the effectiveness of fish oil at reducing CVD risk markers, symptoms of depression and antagonistic disposition, and levels of impulsivity and aggression. The study will also examine whether genetic variations influence the effects of fish oil on markers of inflammation, a characteristic of CVD.

This study will enroll healthy adults who habitually consume low quantities of long-chain omega-3 fatty acids. Participants will be randomly assigned to receive either fish oil supplements or placebo on a daily basis for 4 months. Study visits will occur at baseline and Months 2 and 4. At the baseline and Month 4 visits, participants will undergo blood collection; heart rate measurements; and interviews, psychological tests, and questionnaires to assess mood, disposition, impulsivity, and aggression. Additionally, medication adherence will be measured at the Months 2 and 4 study visits and through phone calls from study staff at Week 2 and Month 3.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Cardiovascular Diseases
  • Mood Disorders
  • Inflammation
  • Dietary Supplement: Fish Oil
    Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis.
    Other Name: Omega-3 Life Formula (PharmaOmega)
  • Dietary Supplement: Soybean Oil (Placebo)
    Participants will take 2 grams of soybean oil supplements on a daily basis.
  • Active Comparator: 1
    Participants will take fish oil supplements daily for 4 months.
    Intervention: Dietary Supplement: Fish Oil
  • Placebo Comparator: 2
    Participants will take soybean oil (placebo) supplements daily for 4 months.
    Intervention: Dietary Supplement: Soybean Oil (Placebo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
275
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently employed at least 25 hours a week, but does not regularly work the third shift (i.e., night shift)
  • English is primary language
  • Consumes less than 300 mg/day of long-chain omega-3 fatty acids.

Exclusion Criteria:

  • Serious allergy to fish (e.g., anaphylaxis, bronchospasm, serious skin reaction)
  • History of atherosclerotic disease (e.g., myocardial infarction) or treatment of angina or claudication (e.g., angioplasty)
  • Reported history of schizophrenia or bipolar disorder
  • Long-term hepatitis
  • Kidney failure
  • Stroke or other neurological disorder
  • Lung disease requiring drug treatment
  • Stage 2 high blood pressure, defined as systolic blood pressure of 160 mm Hg or greater and diastolic blood pressure of 100 mm Hg or greater
  • Alcohol consumption of more than five drinks per day each week (i.e., more than 35 alcoholic drinks each week)
  • Pregnant or breastfeeding
  • Currently taking any cardiovascular, psychotropic, glucocorticoid, lipid-lowering, insulin, or weight loss medications
  • Currently taking fish oil supplements
Both
30 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00663871
567, 2P01HL040962, 2 P01 HL040962
No
University of Pittsburgh
University of Pittsburgh
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • Office of Dietary Supplements (ODS)
Principal Investigator: Matthew F. Muldoon, MD, MPH University of Pittsburgh
University of Pittsburgh
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP