Evaluating the Effects of Omega-3 Fatty Acids on Heart Disease and Behavior
|ClinicalTrials.gov Identifier: NCT00663871|
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : July 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Mood Disorders Inflammation||Dietary Supplement: Fish Oil Dietary Supplement: Soybean Oil (Placebo)||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||275 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||BioBehavioral Studies of Cardiovascular Disease|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
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.
- 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 ]
- Cognitive performance; structural and functional brain imaging post supplementation [ Time Frame: Measured at Month 4 ]
- Moderation of effects of fish oil on inflammatory markers by select genetic polymorphisms [ Time Frame: Measured at Month 4 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663871
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15260|
|Principal Investigator:||Matthew F. Muldoon, MD, MPH||University of Pittsburgh|