N/A
Completed N=272
Evaluating the Effects of Omega-3 Fatty Acids on Heart Disease and Behavior
Source: ClinicalTrials.gov NCT00663871 ↗Enrolled (actual)
272
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Circulating Serum Interleukin-6 (IL-6) — 1.13; 1.01; 0.88; 0.81 pg/mL — p=0.59
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Circulating Serum Interleukin-6 (IL-6) |
1.13; 1.01; 0.88; 0.81 | 0.59 |
| PRIMARY C-reactive Protein (CRP) |
1.00; 0.67; 0.94; 0.64 | 0.21 |
| PRIMARY Negative Affect |
1.76; 1.69; 1.73; 1.59 | 0.92 |
| PRIMARY Impulsivity |
60.44; 59.57; 60.41; 59.38 | 0.86 |
| PRIMARY Aggression |
28.14; 27.55; 27.75; 27.46 | 0.63 |
| PRIMARY Hostility, Barefoot Score |
13.58; 12.54; 13.30; 12.58 | 0.50 |
| PRIMARY Trait Anger |
16.07; 16.01; 15.39; 15.03 | 0.25 |
| PRIMARY Anger Expression |
24.73; 24.50; 22.83; 23.25 | 0.52 |
| PRIMARY Type A, Total Score |
1.0; 1.0; 1.0; 1.0 | 0.52 |
| PRIMARY Mean Successive Difference in Inter-beat Intervals Natural Log Transformed Paced Respiration |
2.99; 3.13; 2.92; 3.08 | 0.68 |
| PRIMARY High Frequency (.12 to .40 Hz) Heart Rate Variability Natural Log Transformed Paced Respiration |
5.93; 6.15; 5.74; 6.13 | 0.16 |
| PRIMARY Total Power (0 to .40 Hz) Heart Rate Variability Natural Log Transformed Paced Respiration |
7.02; 7.21; 6.94; 7.18 | 0.59 |
| PRIMARY Mean Successive Difference in Inter-beat Intervals Natural Log Transformed Unpaced Respiration |
2.97; 3.11; 2.95; 3.03 | 0.35 |
| PRIMARY High Frequency (.12 to .40 Hz) Heart Rate Variability Natural Log Transformed Unpaced Respiration |
5.37; 5.61; 5.29; 5.51 | 0.74 |
| PRIMARY Total Power (0 to .40 Hz) Heart Rate Variability Natural Log Transformed Unpaced Respiration |
7.05; 7.13; 6.98; 7.15 | 0.28 |
| SECONDARY Executive Function |
-0.02; 0.02; 0.07; 0.03 | 0.76 |
| SECONDARY Learning / Episodic Memory |
0.01; -0.01; 0.18; 0.12 | 0.62 |
| SECONDARY Psychomotor Speed |
0.04; -0.04; 0.13; 0.007 | 0.42 |
| SECONDARY Fluid Intelligence |
-0.02; 0.02; -0.005; 0.05 | 0.54 |
| SECONDARY Moderation of Effects of Fish Oil on Inflammatory Markers by Select Genetic Polymorphisms |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00663871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.