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| ID | Type | Description | Link |
|---|---|---|---|
| 2P01HL040962 | U.S. NIH Grant/Contract | View source | |
| R01AT004699 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Office of Dietary Supplements (ODS) | NIH |
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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.
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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish Oil | Active Comparator | Participants will take fish oil supplements daily for 4 months. |
|
| Placebo | Placebo Comparator | Participants will take soybean oil (placebo) supplements daily for 4 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish Oil | Dietary Supplement | Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Structural & Functional MRI | Measures of brain structure and function from magnetic resonance imaging | Baseline and month 4 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew F. Muldoon, MD, MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25373092 | Background | 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. | |
| 31581959 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Circulating Serum Interleukin-6 (IL-6) | Systemic inflammation: fasting serum Interleukin-6 (IL-6) | 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. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline and Month 4 |
|
4 months
Used pre-specified 9 item side effect questionnaire.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fishy belch or after-taste | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew F. Muldoon, MD, MPH | University of Pittsburgh, Heart and Vascular Institute | 412-624-8798 | mfm10@pitt.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D019964 | Mood Disorders |
| D007249 | Inflammation |
| D003863 | Depression |
| D007175 | Impulsive Behavior |
| D000374 | Aggression |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| D013024 | Soybean Oil |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
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| Soybean Oil (Placebo) | Dietary Supplement | Participants will take 2 grams of soybean oil supplements on a daily basis. |
|
| 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 |
| 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. | 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. | 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. | 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 at Month 4 |
| 26497831 | 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. |
| 28121722 | 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. |
| 24736647 | 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. |
| 20181791 | 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. |
| 21753804 | 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. |
| 17383013 | 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. |
| 17574755 | 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. |
| 17991818 | 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. |
| 20060277 | 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. |
| 23884386 | 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. |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 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. |
|
|
|
| Primary | C-reactive Protein (CRP) | fasting serum C-reactive protein (CRP) in milligrams per liter (mg/L) | 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. | Posted | Median | Inter-Quartile Range | mg/L | baseline and month 4 |
|
|
|
|
| Primary | 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). | All randomized participants were analyzed. | Posted | Median | Inter-Quartile Range | units on a scale | baseline and month 4 |
|
|
|
|
| Primary | Impulsivity | Barratt Impulsiveness Scale. The minimum value is 34, and the maximum value is 120. A higher score suggests a worse outcome. | All randomized participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 4 |
|
|
|
|
| Primary | Aggression | Bus-Perry Aggression Questionnaire. The minimum value is 14, and the maximum value is 53. A higher score suggests a worse outcome. | All randomized participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 4 |
|
|
|
|
| Primary | 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. | All randomized participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 4 |
|
|
|
|
| Primary | 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. | All randomized participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 4 |
|
|
|
|
| Primary | 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. | All randomized participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 4 |
|
|
|
|
| Primary | 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. | All randomized participants were analyzed. | Posted | Median | Inter-Quartile Range | units on a scale | baseline and month 4 |
|
|
|
|
| Primary | 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 | One participant was excluded from the analysis due to missing both at baseline and 4-month data.. | Posted | Mean | Standard Deviation | ln(milliseconds) | baseline and month 4 |
|
|
|
|
| Primary | 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) | One participant was excluded from the analysis due to missing both at baseline and 4-month data. | Posted | Mean | Standard Deviation | ln(hertz) | baseline and month 4 |
|
|
|
|
| Primary | 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. | One participant was excluded from the analysis due to missing both at baseline and 4-month data. | Posted | Mean | Standard Deviation | ln(hertz) | baseline and month 4 |
|
|
|
|
| Primary | 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) | One participant was excluded from the analysis due to missing both at baseline and 4-month data. | Posted | Mean | Standard Deviation | ln(milliseconds) | baseline and month 4 |
|
|
|
|
| Primary | 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 | One participant was excluded from the analysis due to missing both at baseline and 4-month data. | Posted | Mean | Standard Deviation | ln(hertz) | baseline and month 4 |
|
|
|
|
| Primary | 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 | One participant in placebo group was excluded from the analysis due to missing both at baseline and 4-month data. | Posted | Mean | Standard Deviation | ln(hertz) | baseline and month 4 |
|
|
|
|
| Secondary | 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. | One participant in placebo group was excluded from the analysis due to missing both at baseline and 4-month data. | Posted | Mean | Standard Deviation | Z-score | Baseline and Month 4 |
|
|
|
|
| Secondary | 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. | One participant in placebo group was excluded from the analysis due to missing both at baseline and 4-month data. | Posted | Mean | Standard Deviation | Z-score | Baseline and Month 4 |
|
|
|
|
| Secondary | 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. | One participant in placebo group was excluded from the analysis due to missing both at baseline and 4-month data. | Posted | Mean | Standard Deviation | Z-score | Baseline and Month 4 |
|
|
|
|
| Secondary | 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. | One participant in placebo group was excluded from the analysis due to missing both at baseline and 4-month data. | Posted | Mean | Standard Deviation | Z-score | Baseline and Month 4 |
|
|
|
|
| Secondary | 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. | This aim was conditional and was not completed per the protocol. | Posted | Measured at Month 4 |
|
|
| Other Pre-specified | Structural & Functional MRI | Measures of brain structure and function from magnetic resonance imaging | Not Posted | Baseline and month 4 | Participants |
| 0 |
| 134 |
| 61 |
| 134 |
| EG001 | 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. | 0 | 138 | 17 | 138 |
| Loose stool, bloating or gas pains | Gastrointestinal disorders | Systematic Assessment |
|
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| D000096762 | Aberrant Motor Behavior in Dementia |
| D012919 | Social Behavior |
| D005223 |
| Fats |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |