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
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Mood Disorders
Inflammation
Dietary Supplement: Fish Oil
Dietary Supplement: Soybean Oil (Placebo)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: BioBehavioral Studies of Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 275
Study Start Date: June 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will take fish oil supplements daily for 4 months.
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)
Placebo Comparator: 2
Participants will take soybean oil (placebo) supplements daily for 4 months.
Dietary Supplement: Soybean Oil (Placebo)
Participants will take 2 grams of soybean oil supplements on a daily basis.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663871

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Matthew F. Muldoon, MD, MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00663871     History of Changes
Other Study ID Numbers: 567, 2P01HL040962, 2 P01 HL040962
Study First Received: April 18, 2008
Last Updated: July 5, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Fish Oil
Omega-3 fatty acids
Affect
Depression
Anger
Nutrition
Impulsivity
Aggression
Cognition
Behavior

Additional relevant MeSH terms:
Inflammation
Cardiovascular Diseases
Mood Disorders
Pathologic Processes
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014