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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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-07-31

Brief Summary

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The aim of this study is to investigate the effects of short- and long-term intervention with EPA and DHA-rich fish oil on gene expression profiles in healthy and hyperlipidemic males.

Detailed Description

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Cardiovascular and coronary heart diseases continue to be the leading causes of morbidity and mortality among adults in Europe and North America. Since the number of elderly people and therefore the number of chronic-inflammatory diseases rise, preventive therapies become more important. Within preventive strategies, nutrition plays a central role.

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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Hyperlipidemia Healthy

Keywords

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Hyperlipidemia coronary heart disease gene expression fish oil DHA, EPA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo - healthy subjects

Dietary Supplement: corn oil capsules (6 per day) about 3 months

Group Type PLACEBO_COMPARATOR

Placebo (corn oil)

Intervention Type DIETARY_SUPPLEMENT

corn oil (6 capsules per day)

Placebo - hyperlipedemic subjects

Dietary Supplement: corn oil capsules (6 per day) about 3 months

Group Type PLACEBO_COMPARATOR

Placebo (corn oil)

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Fish oil

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type EXPERIMENTAL

Fish oil

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Placebo (corn oil)

corn oil (6 capsules per day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* males, 20-50 years
* 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

* Body-Mass-Index (BMI) ≥ 35
* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

51 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gottfried Wilhelm Leibniz Universität Hannover

OTHER

Sponsor Role lead

Responsible Party

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M. Sc. Simone Schmidt

Master of Science

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Germany

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.

Reference Type DERIVED
PMID: 23241455 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22929118 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22621246 (View on PubMed)

Related Links

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http://www.nutrition.uni-hannover.de

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