Cardiovascular DiseasesNCT00663871

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

A study testing Fish Oil in people with Cardiovascular Diseases and Mood Disorders, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 30 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Diseases, Mood Disorders, Inflammation
What is being tested?: Fish Oil
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 272 participants
Where: 1 siteUnited States
Study dates: Jun 2008to Oct 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15260

Other trials in United States

About this study

Official title: BioBehavioral Studies of Cardiovascular Disease

Read the 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.)

Conditions: Cardiovascular Diseases, Mood Disorders, Inflammation
Being tested: Fish Oil, Soybean Oil (Placebo)
Keywords: Fish Oil, Omega-3 fatty acids, Affect, Depression, Anger, Nutrition, Impulsivity, Aggression, Cognition, Behavior
Medical subject headings: Cardiovascular Diseases, Mood Disorders, Inflammation, Depression, Impulsive Behavior, Aggression, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fish OilDietary supplement
Also called Omega-3 Life Formula (PharmaOmega)
Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis.
Soybean Oil (Placebo)Dietary supplement
Participants will take 2 grams of soybean oil supplements on a daily basis.

Study groups in NCT00663871
Study group	Role	What they receive
Fish Oil	Active comparator	Participants will take fish oil supplements daily for 4 months. Receives: Dietary Supplement: Fish Oil
Placebo	Placebo comparator	Participants will take soybean oil (placebo) supplements daily for 4 months. Receives: Dietary Supplement: Soybean Oil (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Executive Function
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.
Measured: Baseline and Month 4
Learning / Episodic Memory
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.
Measured: Baseline and Month 4
Psychomotor Speed
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.
Measured: Baseline and Month 4
Fluid Intelligence
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.
Measured: Baseline and Month 4
Moderation of Effects of Fish Oil on Inflammatory Markers by Select Genetic Polymorphisms
Circulating serum concentrations of IL6 and CRP before and after supplementation with fish oil or placebo.
Measured: Measured at Month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Oct 2012

First posted22 Apr 2008 (estimated)
Study startJun 2008
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00663871
Sponsor's protocol ID: STUDY19060029
Other IDs: 2P01HL040962, R01AT004699
Status last verified: May 2021
First submitted: 18 Apr 2008
Last updated: 11 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 25373092
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.
PubMed 31581959
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.
PubMed 26497831
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.
PubMed 28121722
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.
PubMed 24736647
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.
PubMed 20181791
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.
PubMed 21753804
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.
PubMed 17383013
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.
PubMed 17574755
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.
PubMed 17991818
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.
PubMed 20060277
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.
PubMed 23884386

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BioBehavioral Studies of Cardiovascular Disease
ClinicalTrials.gov ID: NCT00663871
Acronym / sponsor ID: STUDY19060029
Conditions: Cardiovascular Diseases, Mood Disorders, Inflammation
Keywords: Fish Oil, Omega-3 fatty acids, Affect, Depression, Anger, Nutrition, Impulsivity, Aggression
Study type: Interventional
Recruitment status: Completed
Enrolment: 272 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
Study start: Jun 2008
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 22 Apr 2008 (estimated)
Results: Posted 12 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Fish Oil	Active comparator	Dietary Supplement: Fish OilParticipants will take fish oil supplements daily for 4 months.
Placebo	Placebo comparator	Dietary Supplement: Soybean Oil (Placebo)Participants will take soybean oil (placebo) supplements daily for 4 months.

Who may qualify

Ages: 30 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fish OilAlso: Omega-3 Life Formula (PharmaOmega)Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis.	Dietary supplement	Fish Oil
Soybean Oil (Placebo)Participants will take 2 grams of soybean oil supplements on a daily basis.	Dietary supplement	Placebo

Primary outcome

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

5 secondary outcomes

Executive Function
Time frame: Baseline and Month 4
Learning / Episodic Memory
Time frame: Baseline and Month 4
Psychomotor Speed
Time frame: Baseline and Month 4
Fluid Intelligence
Time frame: Baseline and Month 4
Moderation of Effects of Fish Oil on Inflammatory Markers by Select Genetic Polymorphisms
Time frame: Measured at Month 4

Results and safety

Results posted to the registry on 12 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fish Oil	134	124
Placebo	138	131

Primary outcome: Circulating Serum Interleukin-6 (IL-6)

Time frame: Baseline and Month 4. Median (Inter-Quartile Range). Unit: pg/mL

Measure	Fish Oil n = 127	Placebo n = 131
baseline	1.13 (0.465 to 1.79)	1.01 (0.60 to 1.40)
Month 4	0.88 (0.60 to 1.72)	0.81 (0.53 to 1.31)

Fish Oil vs Placebo: Mean Difference (Net): -0.04 (95% CI -0.27 to 0.19), p = 0.59, ANOVA

Population analysed: 11 participants had chronic inflammatory conditions at baseline and were excluded, leaving 129 in fish oil and 132 in placebo groups. The 17 subjects who did not finish the study were retained through use of single-imputation analysis. Any subject missing both baseline and 4-month data could not be retained. TThis applied to 2 fish oil and 1 placebo participants for IL-6, leaving 127 and 131, respectively in the analysis population.

Primary outcome: C-reactive Protein (CRP)

Time frame: baseline and month 4. Median (Inter-Quartile Range). Unit: mg/L

Measure	Fish Oil n = 125	Placebo n = 129
baseline	1.00 (.043 to 2.17)	0.67 (0.30 to 1.67)
month 4	0.94 (.042 to 2.02)	0.64 (0.33 to 1.87)

Fish Oil vs Placebo: Mean Difference (Net): 0.05 (95% CI -0.24 to 0.19), p = 0.21, ANOVA

Population analysed: 11 participants had chronic inflammatory conditions at baseline and were excluded, leaving 129 in fish oil and 132 in placebo groups. The 17 subjects who did not finish the study were retained through use of single-imputation analysis. Any subject missing both baseline and 4-month data could not be retained. This applied to 4 fish oil and 3 placebo participants for CRP, leaving 125 and 129, respectively, in the analysis population.

Primary outcome: Negative Affect

Time frame: baseline and month 4. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Fish Oil n = 134	Placebo n = 138
Baseline	1.76 (1.23 to 2.42)	1.69 (1.28 to 2.45)
Month 4	1.73 (1.20 to 2.33)	1.59 (1.21 to 2.34)

Fish Oil vs Placebo: Odds Ratio (OR): 1.02 (95% CI 0.69 to 1.50), p = 0.92, Mixed Models Analysis

Population analysed: All randomized participants were analyzed.

Primary outcome: Impulsivity

Time frame: baseline and month 4. Mean (Standard Deviation). Unit: units on a scale

Measure	Fish Oil n = 134	Placebo n = 138
Baseline	60.44 (8.53)	59.57 (8.44)
Month 4	60.41 (9.27)	59.38 (8.97)

Fish Oil vs Placebo: Mean Difference (Net): 0.12 (95% CI -1.21 to 1.44), p = 0.86, Mixed Models Analysis

Population analysed: All randomized participants were analyzed.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fish Oil	0 of 134 (0%)	61 of 134 (45.5%)	Not reported
Placebo	0 of 138 (0%)	17 of 138 (12.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25373092Muldoon 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.
Results publication: PubMed 31581959Leckie 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.
Results publication: PubMed 26497831Muldoon 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.
Results publication: PubMed 28121722Ginty 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.
Results publication: PubMed 24736647Cipollina 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.
Results publication: PubMed 20181791Muldoon 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.
Results publication: PubMed 21753804Liu 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.
Results publication: PubMed 17383013Conklin 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.
Results publication: PubMed 17574755Conklin 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.
Results publication: PubMed 17991818Conklin 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.
Results publication: PubMed 20060277Conklin 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.
Results publication: PubMed 23884386Muldoon 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew F. Muldoon, MD, MPH principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fish Oil in people with Cardiovascular Diseases and Mood Disorders, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circulating Serum Interleukin-6 (IL-6) (time frame: Baseline and Month 4). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00663871, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.