Evaluating the Effects of Omega-3 Fatty Acids on Heart Disease and Behavior
Condition: Cardiovascular Diseases; Mood Disorders; Inflammation
MeSH terms: Cardiovascular Diseases; Inflammation; Mood Disorders
Study type: Interventional

Summary: 
      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.
    

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, stroke
      and vascular dementia. 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 explore potentail effects of fish oil supplementation on CVD mechanisms and risk
      markers, and on depressive symptoms, antagonistic disposition, and levels of impulsivity and
      aggression.

      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 the following
      measures as primary study aims: blood collection for inflammatory markers; heart rate and
      variability measurements; and interviews, psychological tests, and questionnaires to assess
      mood, disposition, impulsivity, and aggression.

      As secondary aims, we will test for any effects of fish oil on cognitive performance and, if
      a main effect on inflammatory markers is found, we will test for moderation by select genetic
      polymorphisms.

      As an exploratory aim, we will test for any effects of fish oil on structural or functional
      brain imaging. (This exploratory aim was mistakenly listed as a secondary aim at the time of
      trial registration.)
    

Intervention name(s): Fish Oil; Soybean Oil (Placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis.; Participants will take 2 grams of soybean oil supplements on a daily basis.
Other intervention name(s): Omega-3 Life Formula (PharmaOmega)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Fish Oil; Omega-3 fatty acids; Affect; Depression; Anger; Nutrition; Impulsivity; Aggression; Cognition; Behavior