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Completed

NCT Number: NCT00663871

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

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.

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Key information

Conditions

Cardiovascular Diseases Aberrant Motor Behavior in Dementia Aggression Behavior Behavioral Symptoms Depression Impulsive Behavior Inflammation Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Social Behavior

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

About this study

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.)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis.

Other names: Omega-3 Life Formula (PharmaOmega)

Soybean Oil (Placebo)

Dietary Supplement

Participants will take 2 grams of soybean oil supplements on a daily basis.

Primary outcomes

  1. Circulating Serum Interleukin-6 (IL-6)

    Time frame: Baseline and Month 4

    Systemic inflammation: fasting serum Interleukin-6 (IL-6)

  2. C-reactive Protein (CRP)

    Time frame: baseline and month 4

    fasting serum C-reactive protein (CRP) in milligrams per liter (mg/L)

  3. Negative Affect

    Time frame: baseline and month 4

    Negative affect questions adapted from the Positive and Negative Affect Schedule - Expanded Form administered via ecological momentary assessment. The minimum value is 1, and the maximum value is 6. A higher score are worse (more negative affect).

  4. Impulsivity

    Time frame: baseline and month 4

    Barratt Impulsiveness Scale. The minimum value is 34, and the maximum value is 120. A higher score suggests a worse outcome.

  5. Aggression

    Time frame: baseline and month 4

    Bus-Perry Aggression Questionnaire. The minimum value is 14, and the maximum value is 53. A higher score suggests a worse outcome.

  6. Hostility, Barefoot Score

    Time frame: baseline and month 4

    The 27-item Barefoot Hostility Scale. The minimum value is 1, and the maximum value is 30. A higher score suggests a worse outcome.

  7. Trait Anger

    Time frame: baseline and month 4

    State-Trait Anger Expression Inventory. The minimum value is 10, and the maximum value is 40. A higher score suggests a worse outcome.

  8. Anger Expression

    Time frame: baseline and month 4

    State-Trait Anger Expression Inventory. The minimum value is 0, and the maximum value is 72. A higher score suggests a worse outcome.

  9. Type A, Total Score

    Time frame: baseline and month 4

    Structured Interview - Type A Behavior Pattern using the Interpersonal Hostility Assessment Technique (IHAT). The minimum value is 0, and the maximum value is 12. A higher score suggests a worse outcome.

  10. Mean Successive Difference in Inter-beat Intervals Natural Log Transformed Paced Respiration

    Time frame: baseline and month 4

    Mean successive difference in inter-beat intervals natural log transformed paced respiration in milliseconds

  11. High Frequency (.12 to .40 Hz) Heart Rate Variability Natural Log Transformed Paced Respiration

    Time frame: baseline and month 4

    High frequency (.12 to .40 Hz) heart rate variability natural log transformed paced respiration in Hertz units (Hz)

  12. Total Power (0 to .40 Hz) Heart Rate Variability Natural Log Transformed Paced Respiration

    Time frame: baseline and month 4

    Total power (0 to .40 Hz) heart rate variability natural log transformed paced respiration in Hertz (Hz) units.

  13. Mean Successive Difference in Inter-beat Intervals Natural Log Transformed Unpaced Respiration

    Time frame: baseline and month 4

    Mean successive difference in inter-beat intervals natural log transformed unpaced respiration in milliseconds (msec)

  14. High Frequency (.12 to .40 Hz) Heart Rate Variability Natural Log Transformed Unpaced Respiration

    Time frame: baseline and month 4

    High frequency (.12 to .40 Hz) heart rate variability natural log transformed unpaced respiration in Hertz (Hz) units

  15. Total Power (0 to .40 Hz) Heart Rate Variability Natural Log Transformed Unpaced Respiration

    Time frame: baseline and month 4

    Total power (0 to .40 Hz) heart rate variability natural log transformed unpaced respiration in Hertz (Hz) units

Secondary outcomes

  1. Executive Function

    Time frame: Baseline and Month 4

    Executive function was comprised of trail making B - A time, digit span forward and digit span backward completions. Performance scores on each task were converted into Z-scores, and then averaged across tasks. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate higher function (better outcome). The analysis compared changes in Z-scores between the two treatment groups.

  2. Learning / Episodic Memory

    Time frame: Baseline and Month 4

    Learning/episodic memory was comprised of d' from the four word memory task and the average performance across all trials of the Rey auditory verbal learning test. Performance scores on each task were converted into Z-scores, and then averaged across tasks. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate higher function (better outcome). The analysis compared changes in Z-scores between the two treatment groups.

  3. Psychomotor Speed

    Time frame: Baseline and Month 4

    Psychomotor speed was comprised of trail making A time, Stroop word-only time and color-only time. Performance scores on each task were converted into Z-scores, and then averaged across tasks. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate higher function (better outcome). The analysis compared changes in Z-scores between the two treatment groups.

  4. Fluid Intelligence

    Time frame: Baseline and Month 4

    This outcome was based upon matrix reasoning task raw score, block design task raw score and spatial span forward raw score. Performance scores on each task were converted into Z-scores, and then averaged across tasks. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate higher function (better outcome). The analysis compared changes in Z-scores between the two treatment groups.

  5. Moderation of Effects of Fish Oil on Inflammatory Markers by Select Genetic Polymorphisms

    Time frame: Measured at Month 4

    Circulating serum concentrations of IL6 and CRP before and after supplementation with fish oil or placebo.

Other outcomes

  1. Structural & Functional MRI

    Time frame: Baseline and month 4

    Measures of brain structure and function from magnetic resonance imaging

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Office of Dietary Supplements (ODS)

Registry information

Official study title

BioBehavioral Studies of Cardiovascular Disease

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 22, 2008
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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