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

NCT01089231 | Completed Phase 4 Results

• 2 other identifiers: GWLUH-001GWLUH2010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperlipidemia; Healthy

Keywords

Hyperlipidemia; coronary heart disease; gene expression; fish oil; DHA, EPA

Outcome Measures

Primary Outcomes (1)

• Gene Expression Changes

  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.

  Gene expression changes (number of regulated genes)

Secondary Outcomes (2)

• Fatty Acid Composition of Erythrocyte Membranes (Omega-3 Index)

  baseline and after 12 weeks

• Blood Lipids

  baseline and after 12 weeks

Study Arms (4)

Placebo - healthy subjects

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo (corn oil)

Placebo - hyperlipedemic subjects

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo (corn oil)

Fish oil - hyperlipidemic subjects

EXPERIMENTAL

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

Dietary Supplement: Fish oil

Fish oil - healthy subjects

EXPERIMENTAL

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.

Dietary Supplement: Fish oil

Interventions

Fish oil 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; Fish oil - hyperlipidemic subjects

Placebo (corn oil) DIETARY_SUPPLEMENT

corn oil (6 capsules per day)

Placebo - healthy subjects; Placebo - hyperlipedemic subjects

Eligibility Criteria

• Age: 20 Years - 51 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gottfried Wilhelm Leibniz Universität Hannover: lead

Study Sites (1)

Gottfried Wilhelm Leibniz University of Hanover

Hanover, Lower Saxony, 30167, Germany

Location

Related Publications (3)

• 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.

  PMID: 23241455 DERIVED

• 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.

  PMID: 22929118 DERIVED

• 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.

  PMID: 22621246 DERIVED

Related Links

• web page of the institute

MeSH Terms

Conditions

Hyperlipidemias; Coronary Disease

Interventions

Fish Oils; Corn Oil

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

* 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

Results Point of Contact

• Title: M. Sc. Simone Schmidt
• Organization: Leibniz Universität Hannover

Schmidt@nutrition.uni-hannover.de

+49 (511) 762 5931

Study Officials

• Andreas Hahn, Prof.

  Gottfried Wilhelm Leibniz University of Hanover

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: December 19, 2011
• Results First Posted: December 2, 2011

Record last verified: 2011-12

Locations

DE (1)