Evaluating the Effects of Omega-3 Fatty Acids on Heart Disease and Behavior
NCT ID: NCT00663871
Last Updated: 2021-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
272 participants
INTERVENTIONAL
2008-06-30
2012-10-31
Brief Summary
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Detailed Description
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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.)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Fish Oil
Participants will take fish oil supplements daily for 4 months.
Fish Oil
Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis.
Placebo
Participants will take soybean oil (placebo) supplements daily for 4 months.
Soybean Oil (Placebo)
Participants will take 2 grams of soybean oil supplements on a daily basis.
Interventions
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Fish Oil
Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis.
Soybean Oil (Placebo)
Participants will take 2 grams of soybean oil supplements on a daily basis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* English is primary language
* Consumes less than 300 mg/day of long-chain omega-3 fatty acids.
Exclusion Criteria
* 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
30 Years
55 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
Office of Dietary Supplements (ODS)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Stephen Manuck
Professor
Principal Investigators
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Matthew F. Muldoon, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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