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Effects of Omega-3 Fatty Acids on the Human Gene Expression

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ClinicalTrials.gov Identifier: NCT01089231
Recruitment Status : Completed
First Posted : March 18, 2010
Results First Posted : December 2, 2011
Last Update Posted : December 19, 2011
Sponsor:
Information provided by (Responsible Party):
M. Sc. Simone Schmidt, Gottfried Wilhelm Leibniz Universität Hannover

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Hyperlipidemia
Healthy
Interventions Dietary Supplement: Fish oil
Dietary Supplement: Placebo (corn oil)
Enrollment 40
Recruitment Details 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.
Pre-assignment Details Serum lipid levels of the preselected subjects were determined and 20 normolipidemic and 20 dyslipidemic men were enrolled in the study population.
Arm/Group Title Placebo - Healthy Subjects Placebo - Hyperlipedemic Subjects Fish Oil - Hyperlipidemic Subjects Fish Oil - Healthy Subjects
Hide Arm/Group Description Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6 Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8 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 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
Period Title: Overall Study
Started 10 10 10 10
Completed 6 [1] 8 [2] 8 [3] 9 [4]
Not Completed 4 2 2 1
[1]
4 subjects excluded (2 alcohol use / TG level changes; 1 use of not allowed drugs; 1 low RNA yield)
[2]
2 subjects excluded (1 highly elevated TG and TC data; 1 elevated inflammation (CRP level))
[3]
2 subject excluded (1 use of not allowed drugs; 1 low RNA yield)
[4]
1 subject excluded (low RNA yield)
Arm/Group Title Placebo - Healthy Subjects Placebo - Hyperlipedemic Subjects Fish Oil - Hyperlipidemic Subjects Fish Oil - Healthy Subjects Total
Hide Arm/Group Description Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6 Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8 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 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 of all reporting groups
Overall Number of Baseline Participants 10 10 10 10 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 10 participants 40 participants
37.4  (8.30) 41.8  (8.94) 40.2  (8.64) 37.5  (8.11) 38.82  (8.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 40 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
40
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 10 participants 10 participants 10 participants 10 participants 40 participants
10 10 10 10 40
1.Primary Outcome
Title Gene Expression Changes
Hide Description 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.
Time Frame Gene expression changes (number of regulated genes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo - Healthy Subjects Placebo - Hyperlipedemic Subjects Fish Oil - Hyperlipidemic Subjects Fish Oil - Healthy Subjects
Hide Arm/Group Description:
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
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
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 Number of Participants Analyzed 6 8 8 9
Measure Type: Number
Unit of Measure: number of regulated genes
total (4 hours+7 days+12weeks,without doubles) 841 1041 1639 628
4 hours (total) 320 436 508 264
7 days (total) 418 629 1105 230
12 weeks (total) 500 493 1027 338
4 hours (specific) 94 85 246 140
7 days (specific) 135 242 326 78
12 weeks (specific) 312 287 203 214
2.Secondary Outcome
Title Fatty Acid Composition of Erythrocyte Membranes (Omega-3 Index)
Hide Description Fasting 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.
Time Frame baseline and after 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo - Healthy Subjects Placebo - Hyperlipedemic Subjects Fish Oil - Hyperlipidemic Subjects Fish Oil - Healthy Subjects
Hide Arm/Group Description:
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
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
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 Number of Participants Analyzed 6 8 8 9
Mean (Standard Deviation)
Unit of Measure: percentage of total fatty acids
omega-3 index baseline 5.08  (1.41) 5.27  (1.69) 4.90  (1.80) 5.24  (0.70)
omega-3 index after 12 weeks 4.78  (1.16) 5.50  (1.57) 9.84  (1.26) 10.7  (1.06)
3.Secondary Outcome
Title Blood Lipids
Hide Description Fasting 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.
Time Frame baseline and after 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo - Healthy Subjects Placebo - Hyperlipedemic Subjects Fish Oil - Hyperlipidemic Subjects Fish Oil - Healthy Subjects
Hide Arm/Group Description:
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
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
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 Number of Participants Analyzed 6 8 8 9
Mean (Standard Deviation)
Unit of Measure: mg/dl
total cholesterol (TC) baseline 194.0  (22.2) 261.0  (48.1) 262.2  (61.9) 184.1  (13.3)
total cholesterol (TC) after 12 weeks 188.9  (21.5) 257.5  (60.3) 264.4  (49.2) 198.6  (26.1)
low-density lipoprotein (LDL) baseline 118.1  (25.1) 178.1  (45.4) 146.1  (5.31) 108.7  (12.8)
low-density lipoprotein (LDL) after 12 weeks 118.6  (28.2) 172.6  (54.4) 167.4  (23.6) 117.2  (22.1)
high-density lipoprotein (HDL) baseline 52.7  (12.7) 47.9  (10.0) 45.2  (6.5) 59.0  (10.4)
high-density lipoprotein (HDL) after 12 weeks 52.6  (11.6) 47.4  (8.21) 50.8  (9.43) 65.2  (14.4)
triacylglycerol (TG) baseline 115.6  (53.8) 175.0  (56.2) 322.4  (259.0) 82.4  (35.3)
triacylglycerol (TG) after 12 weeks 87.4  (14.8) 186.9  (49.6) 230.8  (147.0) 66.2  (16.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo - Healthy Subjects Placebo - Hyperlipedemic Subjects Fish Oil - Hyperlipidemic Subjects Fish Oil - Healthy Subjects
Hide Arm/Group Description Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6 Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8 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 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
All-Cause Mortality
Placebo - Healthy Subjects Placebo - Hyperlipedemic Subjects Fish Oil - Hyperlipidemic Subjects Fish Oil - Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo - Healthy Subjects Placebo - Hyperlipedemic Subjects Fish Oil - Hyperlipidemic Subjects Fish Oil - Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.05%
Placebo - Healthy Subjects Placebo - Hyperlipedemic Subjects Fish Oil - Hyperlipidemic Subjects Fish Oil - Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/9 (0.00%) 
  • A higher number of participants would be better to compensate drop outs
  • two pre-screening procedures of lipid levels are generally desirable
  • CO is not an optimal placebo control
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: M. Sc. Simone Schmidt
Organization: Leibniz Universität Hannover
Phone: +49 (511) 762 5931
EMail: Schmidt@nutrition.uni-hannover.de
Layout table for additonal information
Responsible Party: M. Sc. Simone Schmidt, Gottfried Wilhelm Leibniz Universität Hannover
ClinicalTrials.gov Identifier: NCT01089231    
Other Study ID Numbers: GWLUH-001
GWLUH2010 ( Other Identifier: 01 )
First Submitted: March 17, 2010
First Posted: March 18, 2010
Results First Submitted: October 27, 2011
Results First Posted: December 2, 2011
Last Update Posted: December 19, 2011