Effects of Omega-3 Fatty Acids on the Human Gene Expression
NCT ID: NCT01089231
Last Updated: 2011-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2010-03-31
2011-07-31
Brief Summary
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Detailed Description
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Cross-sectional studies suggested that omega-3 fatty acids, especially the very long-chain fatty acids Eicosapentaenoic acid (EPA, C20:5ω3) and Docosahexaenoic acid (DHA, C22:6ω3), are protective against cardiovascular and coronary heart diseases. Their cardio protective potential is based on their positive effects on blood lipids, vascular tonus and blood clotting. A number of controlled clinical trials have shown that EPA and DHA supplementation lower fasting and postprandial plasma concentrations of triglyceride-rich lipoproteins and their remnants. Biochemical research revealed numerous metabolic effects of EPA and DHA, ranging from their effects on membrane fluidity to the modification of the eicosanoid profile.
However, only a few human clinical trials examined the regulative effects of DHA and EPA supplementation on gene expression. Furthermore, to our knowledge no published research data is available dealing with the effect of these fatty acids on gene expression in subjects with hypertriglyceridemia in comparison to healthy subjects. Such findings are of great concern due to hints that especially people with hypertriglyceridemia benefit from the triglyceride lowering effect of EPA and DHA supplementation. Presently it is not well-established if the gene regulative potential of EPA and DHA in these persons differs from healthy persons. These findings could help to understand the differences in the metabolic effects of EPA and DHA in healthy vs. hypertriglyceridemic persons, which have a greater risk for cardiovascular and coronary diseases. Finally, these data could contribute to a knowledge basis for targeted strategies in preventive therapies with the very long-chain omega-3 fatty acids EPA and DHA.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo - healthy subjects
Dietary Supplement: corn oil capsules (6 per day) about 3 months
Placebo (corn oil)
corn oil (6 capsules per day)
Placebo - hyperlipedemic subjects
Dietary Supplement: corn oil capsules (6 per day) about 3 months
Placebo (corn oil)
corn oil (6 capsules per day)
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
Fish oil
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
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.
Fish oil
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
Interventions
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Fish oil
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
Placebo (corn oil)
corn oil (6 capsules per day)
Eligibility Criteria
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Inclusion Criteria
* non-smokers
* ethnicity: Caucasians
* no medical treatment
* healthy subjects:
* no documented disease
* normal blood lipids (triglyceride \< 150 mg/dl; total cholesterol \< 200 mg/dl)
* humans with increased blood lipids (hyperlipidemia)
* documented hypertriglyceridemia or
* triglyceride ≥ 150 mg/dl (≥ 1,7 mmol/l) and
* total cholesterol \> 200 mg/dl (5,2 mmol/l)
* written confirmation of the subjects after detailed oral and written explanation about the study contents, - requirements and risks
* ability and willingness of the participants to attend the investigator's orders (compliance of the study conditions, consumption of the study medicaments according to the dosage commendation)
Exclusion Criteria
* smokers
* medical treatment (especially corticosteroids, anti-inflammatory drugs, blood lipids lowering drugs (e.g. statins, fibrates, bile acid exchanger resin, phytosterols)
* taking any supplements with omega-3 fatty acids, phytosterols, polyglucosamines (Chitosan) or other lipid binding ingredients
* daily consumption of omega-3 fatty acids rich fish (salmon, mackerel, herring)
* heavy chronic diseases (tumors, diabetes typ 1, etc.), documented heart disease, documented blood clotting disorders, renal failure, liver diseases
* documented blood clotting disorders and consumption of coagulation-inhibiting drugs (for example Marcumar, ASS)
* allergy or intolerance to fish/fish oil or any of the study ingredients of the test products
* chronic gastro-intestinal diseases (Colitis ulcerosa, Morbus Crohn, pancreatic insufficiency)
* donation of blood in the last 6 weeks
* routine consumption of laxative
* alcohol-, drug- and/or medicament dependence
* subjects who are not in agreement with the study conditions
* refusal or rather reset of the consent from the subject
* active participation in other investigational drug or device trial within the last 30 days
20 Years
51 Years
MALE
Yes
Sponsors
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Gottfried Wilhelm Leibniz Universität Hannover
OTHER
Responsible Party
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M. Sc. Simone Schmidt
Master of Science
Principal Investigators
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Andreas Hahn, Prof.
Role: STUDY_DIRECTOR
Gottfried Wilhelm Leibniz University of Hanover
Locations
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Gottfried Wilhelm Leibniz University of Hanover
Hanover, Lower Saxony, Germany
Countries
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References
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Schmidt S, Willers J, Stahl F, Mutz KO, Scheper T, Hahn A, Schuchardt JP. Regulation of lipid metabolism-related gene expression in whole blood cells of normo- and dyslipidemic men after fish oil supplementation. Lipids Health Dis. 2012 Dec 14;11:172. doi: 10.1186/1476-511X-11-172.
Schmidt S, Stahl F, Mutz KO, Scheper T, Hahn A, Schuchardt JP. Different gene expression profiles in normo- and dyslipidemic men after fish oil supplementation: results from a randomized controlled trial. Lipids Health Dis. 2012 Aug 29;11:105. doi: 10.1186/1476-511X-11-105.
Schmidt S, Stahl F, Mutz KO, Scheper T, Hahn A, Schuchardt JP. Transcriptome-based identification of antioxidative gene expression after fish oil supplementation in normo- and dyslipidemic men. Nutr Metab (Lond). 2012 May 23;9(1):45. doi: 10.1186/1743-7075-9-45.
Related Links
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web page of the institute
Other Identifiers
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GWLUH2010
Identifier Type: OTHER
Identifier Source: secondary_id
GWLUH-001
Identifier Type: -
Identifier Source: org_study_id