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

NCT00663871 | Completed Results

• 3 other identifiers: STUDY190600292P01HL040962R01AT004699
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Mood Disorders; Inflammation

Keywords

Fish Oil; Omega-3 fatty acids; Affect; Depression; Anger; Nutrition; Impulsivity; Aggression; Cognition; Behavior

Outcome Measures

Primary Outcomes (15)

• Circulating Serum Interleukin-6 (IL-6)

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

  Baseline and Month 4

• C-reactive Protein (CRP)

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

  baseline and month 4

• Negative Affect

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

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

  baseline and month 4

Secondary Outcomes (5)

• Executive Function

  Baseline and Month 4

• Learning / Episodic Memory

  Baseline and Month 4

• Psychomotor Speed

  Baseline and Month 4

• Fluid Intelligence

  Baseline and Month 4

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

  Measured at Month 4

Other Outcomes (1)

• Structural & Functional MRI

  Baseline and month 4

Study Arms (2)

Fish Oil

ACTIVE COMPARATOR

Participants will take fish oil supplements daily for 4 months.

Dietary Supplement: Fish Oil

Placebo

PLACEBO COMPARATOR

Participants will take soybean oil (placebo) supplements daily for 4 months.

Dietary Supplement: Soybean Oil (Placebo)

Interventions

Fish Oil DIETARY_SUPPLEMENT

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

Also known as: Omega-3 Life Formula (PharmaOmega)

Fish Oil

Soybean Oil (Placebo) DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (12)

• Muldoon MF, Ryan CM, Yao JK, Conklin SM, Manuck SB. Long-chain omega-3 fatty acids and optimization of cognitive performance. Mil Med. 2014 Nov;179(11 Suppl):95-105. doi: 10.7205/MILMED-D-14-00168.

  PMID: 25373092 BACKGROUND

• Leckie RL, Lehman DE, Gianaros PJ, Erickson KI, Sereika SM, Kuan DCH, Manuck SB, Ryan CM, Yao JK, Muldoon MF. The effects of omega-3 fatty acids on neuropsychological functioning and brain morphology in mid-life adults: a randomized clinical trial. Psychol Med. 2020 Oct;50(14):2425-2434. doi: 10.1017/S0033291719002617. Epub 2019 Oct 4.

  PMID: 31581959 RESULT

• Muldoon MF, Laderian B, Kuan DC, Sereika SM, Marsland AL, Manuck SB. Fish oil supplementation does not lower C-reactive protein or interleukin-6 levels in healthy adults. J Intern Med. 2016 Jan;279(1):98-109. doi: 10.1111/joim.12442. Epub 2015 Oct 26.

  PMID: 26497831 RESULT

• Ginty AT, Muldoon MF, Kuan DCH, Schirda B, Kamarck TW, Jennings JR, Manuck SB, Gianaros PJ. Omega-3 Supplementation and the Neural Correlates of Negative Affect and Impulsivity: A Double-Blind, Randomized, Placebo-Controlled Trial in Midlife Adults. Psychosom Med. 2017 Jun;79(5):549-556. doi: 10.1097/PSY.0000000000000453.

  PMID: 28121722 RESULT

• Cipollina C, Salvatore SR, Muldoon MF, Freeman BA, Schopfer FJ. Generation and dietary modulation of anti-inflammatory electrophilic omega-3 fatty acid derivatives. PLoS One. 2014 Apr 15;9(4):e94836. doi: 10.1371/journal.pone.0094836. eCollection 2014.

  PMID: 24736647 RESULT

• Muldoon MF, Ryan CM, Sheu L, Yao JK, Conklin SM, Manuck SB. Serum phospholipid docosahexaenonic acid is associated with cognitive functioning during middle adulthood. J Nutr. 2010 Apr;140(4):848-53. doi: 10.3945/jn.109.119578. Epub 2010 Feb 24.

  PMID: 20181791 RESULT

• Liu JC, Conklin SM, Manuck SB, Yao JK, Muldoon MF. Long-chain omega-3 fatty acids and blood pressure. Am J Hypertens. 2011 Oct;24(10):1121-6. doi: 10.1038/ajh.2011.120. Epub 2011 Jul 14.

  PMID: 21753804 RESULT

• Conklin SM, Harris JI, Manuck SB, Yao JK, Hibbeln JR, Muldoon MF. Serum omega-3 fatty acids are associated with variation in mood, personality and behavior in hypercholesterolemic community volunteers. Psychiatry Res. 2007 Jul 30;152(1):1-10. doi: 10.1016/j.psychres.2006.10.006. Epub 2007 Mar 23.

  PMID: 17383013 RESULT

• Conklin SM, Gianaros PJ, Brown SM, Yao JK, Hariri AR, Manuck SB, Muldoon MF. Long-chain omega-3 fatty acid intake is associated positively with corticolimbic gray matter volume in healthy adults. Neurosci Lett. 2007 Jun 29;421(3):209-12. doi: 10.1016/j.neulet.2007.04.086. Epub 2007 Jun 2.

  PMID: 17574755 RESULT

• Conklin SM, Manuck SB, Yao JK, Flory JD, Hibbeln JR, Muldoon MF. High omega-6 and low omega-3 fatty acids are associated with depressive symptoms and neuroticism. Psychosom Med. 2007 Dec;69(9):932-4. doi: 10.1097/PSY.0b013e31815aaa42. Epub 2007 Nov 8.

  PMID: 17991818 RESULT

• Conklin SM, Runyan CA, Leonard S, Reddy RD, Muldoon MF, Yao JK. Age-related changes of n-3 and n-6 polyunsaturated fatty acids in the anterior cingulate cortex of individuals with major depressive disorder. Prostaglandins Leukot Essent Fatty Acids. 2010 Feb-Mar;82(2-3):111-9. doi: 10.1016/j.plefa.2009.12.002. Epub 2010 Jan 8.

  PMID: 20060277 RESULT

• Muldoon MF, Erickson KI, Goodpaster BH, Jakicic JM, Conklin SM, Sekikawa A, Yao JK, Manuck SB. Concurrent physical activity modifies the association between n3 long-chain fatty acids and cardiometabolic risk in midlife adults. J Nutr. 2013 Sep;143(9):1414-20. doi: 10.3945/jn.113.174078. Epub 2013 Jul 24.

  PMID: 23884386 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Mood Disorders; Inflammation; Depression; Impulsive Behavior; Aggression; Behavior

Interventions

Fish Oils; Soybean Oil

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Aberrant Motor Behavior in Dementia; Social Behavior

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Matthew F. Muldoon, MD, MPH
• Organization: University of Pittsburgh, Heart and Vascular Institute

mfm10@pitt.edu

412-624-8798

Study Officials

• Matthew F. Muldoon, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 11, 2021
• Results First Posted: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)