Trial Outcomes & Findings for Effects of Omega-3 Fatty Acids on the Human Gene Expression (NCT NCT01089231)
NCT ID: NCT01089231
Last Updated: 2011-12-19
Results Overview
Gene expression changes were measured by using whole genome microarrays. The expression values of all genes were compared between baseline and 4 hours, 7 days and twelve weeks after supplementation with FO or CO and differentially expressed genes were detected by standard two-state pooled-variance t-test (p\<0,05). The number of differentially expressed genes (regulated genes)compared to the baseline values were determined for every study group in total as well as for every time point (4 hours, 7 days, 12 weeks)in total and specifically.
COMPLETED
PHASE4
40 participants
Gene expression changes (number of regulated genes)
2011-12-19
Participant Flow
The recruitment of subjects was performed by several advertisements and study placards in hanover from january until february 2010. By a telephonic preselection 106 subjects were selected according to inclusion criteria.
Serum lipid levels of the preselected subjects were determined and 20 normolipidemic and 20 dyslipidemic men were enrolled in the study population.
Participant milestones
| Measure |
Placebo - Healthy Subjects
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
|
Placebo - Hyperlipedemic Subjects
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
|
Fish Oil - Hyperlipidemic Subjects
Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
|
Fish Oil - Healthy Subjects
Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
8
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Omega-3 Fatty Acids on the Human Gene Expression
Baseline characteristics by cohort
| Measure |
Placebo - Healthy Subjects
n=10 Participants
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
|
Placebo - Hyperlipedemic Subjects
n=10 Participants
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
|
Fish Oil - Hyperlipidemic Subjects
n=10 Participants
Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
|
Fish Oil - Healthy Subjects
n=10 Participants
Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
|
Total
n=40 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
37.4 years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 8.94 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 8.64 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 8.11 • n=4 Participants
|
38.82 years
STANDARD_DEVIATION 8.29 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
40 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Gene expression changes (number of regulated genes)Gene expression changes were measured by using whole genome microarrays. The expression values of all genes were compared between baseline and 4 hours, 7 days and twelve weeks after supplementation with FO or CO and differentially expressed genes were detected by standard two-state pooled-variance t-test (p\<0,05). The number of differentially expressed genes (regulated genes)compared to the baseline values were determined for every study group in total as well as for every time point (4 hours, 7 days, 12 weeks)in total and specifically.
Outcome measures
| Measure |
Placebo - Healthy Subjects
n=6 Participants
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
|
Placebo - Hyperlipedemic Subjects
n=8 Participants
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
|
Fish Oil - Hyperlipidemic Subjects
n=8 Participants
Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
|
Fish Oil - Healthy Subjects
n=9 Participants
Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
|
|---|---|---|---|---|
|
Gene Expression Changes
total (4 hours+7 days+12weeks,without doubles)
|
841 number of regulated genes
|
1041 number of regulated genes
|
1639 number of regulated genes
|
628 number of regulated genes
|
|
Gene Expression Changes
4 hours (total)
|
320 number of regulated genes
|
436 number of regulated genes
|
508 number of regulated genes
|
264 number of regulated genes
|
|
Gene Expression Changes
7 days (total)
|
418 number of regulated genes
|
629 number of regulated genes
|
1105 number of regulated genes
|
230 number of regulated genes
|
|
Gene Expression Changes
12 weeks (total)
|
500 number of regulated genes
|
493 number of regulated genes
|
1027 number of regulated genes
|
338 number of regulated genes
|
|
Gene Expression Changes
4 hours (specific)
|
94 number of regulated genes
|
85 number of regulated genes
|
246 number of regulated genes
|
140 number of regulated genes
|
|
Gene Expression Changes
7 days (specific)
|
135 number of regulated genes
|
242 number of regulated genes
|
326 number of regulated genes
|
78 number of regulated genes
|
|
Gene Expression Changes
12 weeks (specific)
|
312 number of regulated genes
|
287 number of regulated genes
|
203 number of regulated genes
|
214 number of regulated genes
|
SECONDARY outcome
Timeframe: baseline and after 12 weeksFasting venous blood samples were collected and RBC membrane FA composition including the omega-3 index, given as EPA + DHA, was analyzed at baseline and after 12 weeks according to the omega-3 index methodology (Harris \& von Schacky, 2004). Results are presented as a percentage of the total identified FAs after response factor correction. The coefficient of variation for EPA + DHA was 5%. Quality was assured according to DIN ISO 15189.
Outcome measures
| Measure |
Placebo - Healthy Subjects
n=6 Participants
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
|
Placebo - Hyperlipedemic Subjects
n=8 Participants
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
|
Fish Oil - Hyperlipidemic Subjects
n=8 Participants
Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
|
Fish Oil - Healthy Subjects
n=9 Participants
Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
|
|---|---|---|---|---|
|
Fatty Acid Composition of Erythrocyte Membranes (Omega-3 Index)
omega-3 index baseline
|
5.08 percentage of total fatty acids
Standard Deviation 1.41
|
5.27 percentage of total fatty acids
Standard Deviation 1.69
|
4.90 percentage of total fatty acids
Standard Deviation 1.80
|
5.24 percentage of total fatty acids
Standard Deviation 0.70
|
|
Fatty Acid Composition of Erythrocyte Membranes (Omega-3 Index)
omega-3 index after 12 weeks
|
4.78 percentage of total fatty acids
Standard Deviation 1.16
|
5.50 percentage of total fatty acids
Standard Deviation 1.57
|
9.84 percentage of total fatty acids
Standard Deviation 1.26
|
10.7 percentage of total fatty acids
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: baseline and after 12 weeksFasting venous blood samples were collected and blood lipid levels were determined by an external contract laboratory (LADR, Hannover; Germany) at baseline (t0), after one week (t1) and after 12 weeks (t12) of supplementation.
Outcome measures
| Measure |
Placebo - Healthy Subjects
n=6 Participants
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
|
Placebo - Hyperlipedemic Subjects
n=8 Participants
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
|
Fish Oil - Hyperlipidemic Subjects
n=8 Participants
Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
|
Fish Oil - Healthy Subjects
n=9 Participants
Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
|
|---|---|---|---|---|
|
Blood Lipids
total cholesterol (TC) baseline
|
194.0 mg/dl
Standard Deviation 22.2
|
261.0 mg/dl
Standard Deviation 48.1
|
262.2 mg/dl
Standard Deviation 61.9
|
184.1 mg/dl
Standard Deviation 13.3
|
|
Blood Lipids
total cholesterol (TC) after 12 weeks
|
188.9 mg/dl
Standard Deviation 21.5
|
257.5 mg/dl
Standard Deviation 60.3
|
264.4 mg/dl
Standard Deviation 49.2
|
198.6 mg/dl
Standard Deviation 26.1
|
|
Blood Lipids
low-density lipoprotein (LDL) baseline
|
118.1 mg/dl
Standard Deviation 25.1
|
178.1 mg/dl
Standard Deviation 45.4
|
146.1 mg/dl
Standard Deviation 5.31
|
108.7 mg/dl
Standard Deviation 12.8
|
|
Blood Lipids
low-density lipoprotein (LDL) after 12 weeks
|
118.6 mg/dl
Standard Deviation 28.2
|
172.6 mg/dl
Standard Deviation 54.4
|
167.4 mg/dl
Standard Deviation 23.6
|
117.2 mg/dl
Standard Deviation 22.1
|
|
Blood Lipids
high-density lipoprotein (HDL) baseline
|
52.7 mg/dl
Standard Deviation 12.7
|
47.9 mg/dl
Standard Deviation 10.0
|
45.2 mg/dl
Standard Deviation 6.5
|
59.0 mg/dl
Standard Deviation 10.4
|
|
Blood Lipids
high-density lipoprotein (HDL) after 12 weeks
|
52.6 mg/dl
Standard Deviation 11.6
|
47.4 mg/dl
Standard Deviation 8.21
|
50.8 mg/dl
Standard Deviation 9.43
|
65.2 mg/dl
Standard Deviation 14.4
|
|
Blood Lipids
triacylglycerol (TG) baseline
|
115.6 mg/dl
Standard Deviation 53.8
|
175.0 mg/dl
Standard Deviation 56.2
|
322.4 mg/dl
Standard Deviation 259.0
|
82.4 mg/dl
Standard Deviation 35.3
|
|
Blood Lipids
triacylglycerol (TG) after 12 weeks
|
87.4 mg/dl
Standard Deviation 14.8
|
186.9 mg/dl
Standard Deviation 49.6
|
230.8 mg/dl
Standard Deviation 147.0
|
66.2 mg/dl
Standard Deviation 16.7
|
Adverse Events
Placebo - Healthy Subjects
Placebo - Hyperlipedemic Subjects
Fish Oil - Hyperlipidemic Subjects
Fish Oil - Healthy Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
M. Sc. Simone Schmidt
Leibniz Universität Hannover
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place