Trial Outcomes & Findings for Evaluating the Effects of Omega-3 Fatty Acids on Heart Disease and Behavior (NCT NCT00663871)
NCT ID: NCT00663871
Last Updated: 2021-06-11
Results Overview
Systemic inflammation: fasting serum Interleukin-6 (IL-6)
COMPLETED
NA
272 participants
Baseline and Month 4
2021-06-11
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
|
Overall Study
STARTED
|
134
|
138
|
|
Overall Study
COMPLETED
|
124
|
131
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
Baseline Characteristics
Evaluating the Effects of Omega-3 Fatty Acids on Heart Disease and Behavior
Baseline characteristics by cohort
| Measure |
Fish Oil
n=134 Participants
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
n=138 Participants
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.
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
134 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
132 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
109 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
134 participants
n=5 Participants
|
138 participants
n=7 Participants
|
272 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 4Population: 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.
Systemic inflammation: fasting serum Interleukin-6 (IL-6)
Outcome measures
| Measure |
Fish Oil
n=127 Participants
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
n=131 Participants
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.
|
|---|---|---|
|
Circulating Serum Interleukin-6 (IL-6)
baseline
|
1.13 pg/mL
Interval 0.465 to 1.79
|
1.01 pg/mL
Interval 0.6 to 1.4
|
|
Circulating Serum Interleukin-6 (IL-6)
Month 4
|
0.88 pg/mL
Interval 0.6 to 1.72
|
0.81 pg/mL
Interval 0.53 to 1.31
|
PRIMARY outcome
Timeframe: baseline and month 4Population: 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.
fasting serum C-reactive protein (CRP) in milligrams per liter (mg/L)
Outcome measures
| Measure |
Fish Oil
n=125 Participants
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
n=129 Participants
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.
|
|---|---|---|
|
C-reactive Protein (CRP)
baseline
|
1.00 mg/L
Interval 0.043 to 2.17
|
0.67 mg/L
Interval 0.3 to 1.67
|
|
C-reactive Protein (CRP)
month 4
|
0.94 mg/L
Interval 0.042 to 2.02
|
0.64 mg/L
Interval 0.33 to 1.87
|
PRIMARY outcome
Timeframe: baseline and month 4Population: All randomized participants were analyzed.
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).
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=138 Participants
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.
|
|---|---|---|
|
Negative Affect
Baseline
|
1.76 units on a scale
Interval 1.23 to 2.42
|
1.69 units on a scale
Interval 1.28 to 2.45
|
|
Negative Affect
Month 4
|
1.73 units on a scale
Interval 1.2 to 2.33
|
1.59 units on a scale
Interval 1.21 to 2.34
|
PRIMARY outcome
Timeframe: baseline and month 4Population: All randomized participants were analyzed.
Barratt Impulsiveness Scale. The minimum value is 34, and the maximum value is 120. A higher score suggests a worse outcome.
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=138 Participants
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.
|
|---|---|---|
|
Impulsivity
Baseline
|
60.44 units on a scale
Standard Deviation 8.53
|
59.57 units on a scale
Standard Deviation 8.44
|
|
Impulsivity
Month 4
|
60.41 units on a scale
Standard Deviation 9.27
|
59.38 units on a scale
Standard Deviation 8.97
|
PRIMARY outcome
Timeframe: baseline and month 4Population: All randomized participants were analyzed.
Bus-Perry Aggression Questionnaire. The minimum value is 14, and the maximum value is 53. A higher score suggests a worse outcome.
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=138 Participants
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.
|
|---|---|---|
|
Aggression
Baseline
|
28.14 units on a scale
Standard Deviation 8.32
|
27.55 units on a scale
Standard Deviation 7.51
|
|
Aggression
Month 4
|
27.75 units on a scale
Standard Deviation 8.90
|
27.46 units on a scale
Standard Deviation 7.72
|
PRIMARY outcome
Timeframe: baseline and month 4Population: All randomized participants were analyzed.
The 27-item Barefoot Hostility Scale. The minimum value is 1, and the maximum value is 30. A higher score suggests a worse outcome.
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=138 Participants
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.
|
|---|---|---|
|
Hostility, Barefoot Score
Baseline
|
13.58 units on a scale
Standard Deviation 6.52
|
12.54 units on a scale
Standard Deviation 6.21
|
|
Hostility, Barefoot Score
Month 4
|
13.30 units on a scale
Standard Deviation 6.53
|
12.58 units on a scale
Standard Deviation 6.13
|
PRIMARY outcome
Timeframe: baseline and month 4Population: All randomized participants were analyzed.
State-Trait Anger Expression Inventory. The minimum value is 10, and the maximum value is 40. A higher score suggests a worse outcome.
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=138 Participants
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.
|
|---|---|---|
|
Trait Anger
Baseline
|
16.07 units on a scale
Standard Deviation 3.69
|
16.01 units on a scale
Standard Deviation 3.33
|
|
Trait Anger
Month 4
|
15.39 units on a scale
Standard Deviation 3.32
|
15.03 units on a scale
Standard Deviation 3.21
|
PRIMARY outcome
Timeframe: baseline and month 4Population: All randomized participants were analyzed.
State-Trait Anger Expression Inventory. The minimum value is 0, and the maximum value is 72. A higher score suggests a worse outcome.
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=138 Participants
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.
|
|---|---|---|
|
Anger Expression
Baseline
|
24.73 units on a scale
Standard Deviation 8.86
|
24.50 units on a scale
Standard Deviation 8.38
|
|
Anger Expression
Month 4
|
22.83 units on a scale
Standard Deviation 8.63
|
23.25 units on a scale
Standard Deviation 7.77
|
PRIMARY outcome
Timeframe: baseline and month 4Population: All randomized participants were analyzed.
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.
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=138 Participants
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.
|
|---|---|---|
|
Type A, Total Score
Baseline
|
1.0 units on a scale
Interval 0.0 to 2.5
|
1.0 units on a scale
Interval 0.0 to 2.0
|
|
Type A, Total Score
Month 4
|
1.0 units on a scale
Interval 0.0 to 2.0
|
1.0 units on a scale
Interval 0.5 to 1.83
|
PRIMARY outcome
Timeframe: baseline and month 4Population: One participant was excluded from the analysis due to missing both at baseline and 4-month data..
Mean successive difference in inter-beat intervals natural log transformed paced respiration in milliseconds
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=137 Participants
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.
|
|---|---|---|
|
Mean Successive Difference in Inter-beat Intervals Natural Log Transformed Paced Respiration
Baseline
|
2.99 ln(milliseconds)
Standard Deviation 0.77
|
3.13 ln(milliseconds)
Standard Deviation 0.69
|
|
Mean Successive Difference in Inter-beat Intervals Natural Log Transformed Paced Respiration
Month 4
|
2.92 ln(milliseconds)
Standard Deviation 0.83
|
3.08 ln(milliseconds)
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: baseline and month 4Population: One participant was excluded from the analysis due to missing both at baseline and 4-month data.
High frequency (.12 to .40 Hz) heart rate variability natural log transformed paced respiration in Hertz units (Hz)
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=137 Participants
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.
|
|---|---|---|
|
High Frequency (.12 to .40 Hz) Heart Rate Variability Natural Log Transformed Paced Respiration
Baseline
|
5.93 ln(hertz)
Standard Deviation 1.52
|
6.15 ln(hertz)
Standard Deviation 1.38
|
|
High Frequency (.12 to .40 Hz) Heart Rate Variability Natural Log Transformed Paced Respiration
Month 4
|
5.74 ln(hertz)
Standard Deviation 1.66
|
6.13 ln(hertz)
Standard Deviation 1.28
|
PRIMARY outcome
Timeframe: baseline and month 4Population: One participant was excluded from the analysis due to missing both at baseline and 4-month data.
Total power (0 to .40 Hz) heart rate variability natural log transformed paced respiration in Hertz (Hz) units.
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=137 Participants
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.
|
|---|---|---|
|
Total Power (0 to .40 Hz) Heart Rate Variability Natural Log Transformed Paced Respiration
Baseline
|
7.02 ln(hertz)
Standard Deviation 1.10
|
7.21 ln(hertz)
Standard Deviation 0.97
|
|
Total Power (0 to .40 Hz) Heart Rate Variability Natural Log Transformed Paced Respiration
Month 4
|
6.94 ln(hertz)
Standard Deviation 1.10
|
7.18 ln(hertz)
Standard Deviation 0.92
|
PRIMARY outcome
Timeframe: baseline and month 4Population: One participant was excluded from the analysis due to missing both at baseline and 4-month data.
Mean successive difference in inter-beat intervals natural log transformed unpaced respiration in milliseconds (msec)
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=137 Participants
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.
|
|---|---|---|
|
Mean Successive Difference in Inter-beat Intervals Natural Log Transformed Unpaced Respiration
Baseline
|
2.97 ln(milliseconds)
Standard Deviation 0.71
|
3.11 ln(milliseconds)
Standard Deviation 0.67
|
|
Mean Successive Difference in Inter-beat Intervals Natural Log Transformed Unpaced Respiration
Month 4
|
2.95 ln(milliseconds)
Standard Deviation 0.71
|
3.03 ln(milliseconds)
Standard Deviation 0.59
|
PRIMARY outcome
Timeframe: baseline and month 4Population: One participant was excluded from the analysis due to missing both at baseline and 4-month data.
High frequency (.12 to .40 Hz) heart rate variability natural log transformed unpaced respiration in Hertz (Hz) units
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=137 Participants
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.
|
|---|---|---|
|
High Frequency (.12 to .40 Hz) Heart Rate Variability Natural Log Transformed Unpaced Respiration
Baseline
|
5.37 ln(hertz)
Standard Deviation 1.40
|
5.61 ln(hertz)
Standard Deviation 1.28
|
|
High Frequency (.12 to .40 Hz) Heart Rate Variability Natural Log Transformed Unpaced Respiration
Month 4
|
5.29 ln(hertz)
Standard Deviation 1.41
|
5.51 ln(hertz)
Standard Deviation 1.21
|
PRIMARY outcome
Timeframe: baseline and month 4Population: One participant in placebo group was excluded from the analysis due to missing both at baseline and 4-month data.
Total power (0 to .40 Hz) heart rate variability natural log transformed unpaced respiration in Hertz (Hz) units
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=137 Participants
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.
|
|---|---|---|
|
Total Power (0 to .40 Hz) Heart Rate Variability Natural Log Transformed Unpaced Respiration
Baseline
|
7.05 ln(hertz)
Standard Deviation 0.98
|
7.13 ln(hertz)
Standard Deviation 0.97
|
|
Total Power (0 to .40 Hz) Heart Rate Variability Natural Log Transformed Unpaced Respiration
Month 4
|
6.98 ln(hertz)
Standard Deviation 0.97
|
7.15 ln(hertz)
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline and Month 4Population: One participant in placebo group was excluded from the analysis due to missing both at baseline and 4-month data.
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.
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=137 Participants
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.
|
|---|---|---|
|
Executive Function
baseline
|
-0.02 Z-score
Standard Deviation 0.57
|
0.02 Z-score
Standard Deviation 0.61
|
|
Executive Function
Month 4
|
0.07 Z-score
Standard Deviation 0.62
|
0.03 Z-score
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline and Month 4Population: One participant in placebo group was excluded from the analysis due to missing both at baseline and 4-month data.
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.
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=137 Participants
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.
|
|---|---|---|
|
Learning / Episodic Memory
baseline
|
0.01 Z-score
Standard Deviation 0.87
|
-0.01 Z-score
Standard Deviation 0.86
|
|
Learning / Episodic Memory
Month 4
|
0.18 Z-score
Standard Deviation 0.85
|
0.12 Z-score
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline and Month 4Population: One participant in placebo group was excluded from the analysis due to missing both at baseline and 4-month data.
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.
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=137 Participants
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.
|
|---|---|---|
|
Psychomotor Speed
baseline
|
0.04 Z-score
Standard Deviation 0.63
|
-0.04 Z-score
Standard Deviation 0.60
|
|
Psychomotor Speed
Month 4
|
0.13 Z-score
Standard Deviation 0.54
|
0.007 Z-score
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Baseline and Month 4Population: One participant in placebo group was excluded from the analysis due to missing both at baseline and 4-month data.
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.
Outcome measures
| Measure |
Fish Oil
n=134 Participants
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
n=137 Participants
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.
|
|---|---|---|
|
Fluid Intelligence
baseline
|
-0.02 Z-score
Standard Deviation 0.85
|
0.02 Z-score
Standard Deviation 0.90
|
|
Fluid Intelligence
Month 4
|
-0.005 Z-score
Standard Deviation 0.82
|
0.05 Z-score
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Measured at Month 4Population: This aim was conditional and was not completed per the protocol.
Circulating serum concentrations of IL6 and CRP before and after supplementation with fish oil or placebo.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 4Measures of brain structure and function from magnetic resonance imaging
Outcome measures
Outcome data not reported
Adverse Events
Fish Oil
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fish Oil
n=134 participants at risk
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
n=138 participants at risk
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.
|
|---|---|---|
|
General disorders
Fishy belch or after-taste
|
38.1%
51/134 • Number of events 51 • 4 months
Used pre-specified 9 item side effect questionnaire.
|
10.1%
14/138 • Number of events 14 • 4 months
Used pre-specified 9 item side effect questionnaire.
|
|
Gastrointestinal disorders
Loose stool, bloating or gas pains
|
7.5%
10/134 • Number of events 10 • 4 months
Used pre-specified 9 item side effect questionnaire.
|
2.2%
3/138 • Number of events 3 • 4 months
Used pre-specified 9 item side effect questionnaire.
|
Additional Information
Matthew F. Muldoon, MD, MPH
University of Pittsburgh, Heart and Vascular Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place