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

May 20, 2021 updated by: Stephen Manuck, University of Pittsburgh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.)

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fish Oil
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 Names:
  • Omega-3 Life Formula (PharmaOmega)
Placebo Comparator: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating Serum Interleukin-6 (IL-6)
Time Frame: Baseline and Month 4
Systemic inflammation: fasting serum Interleukin-6 (IL-6)
Baseline and Month 4
C-reactive Protein (CRP)
Time Frame: baseline and month 4
fasting serum C-reactive protein (CRP) in milligrams per liter (mg/L)
baseline and month 4
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).
baseline and month 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.
baseline and month 4
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.
baseline and month 4
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.
baseline and month 4
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.
baseline and month 4
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.
baseline and month 4
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.
baseline and month 4
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
baseline and month 4
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)
baseline and month 4
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.
baseline and month 4
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)
baseline and month 4
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
baseline and month 4
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
baseline and month 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Month 4
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.
Baseline and Month 4
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.
Baseline and Month 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.
Baseline and Month 4
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.
Measured at Month 4

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structural & Functional MRI
Time Frame: Baseline and month 4
Measures of brain structure and function from magnetic resonance imaging
Baseline and month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

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

Investigators

  • Principal Investigator: Matthew F. Muldoon, MD, MPH, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19060029
  • 2P01HL040962 (U.S. NIH Grant/Contract)
  • R01AT004699 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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