Phase 4
N=40
Effects of Omega-3 Fatty Acids on the Human Gene Expression
Hyperlipidemia · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01089231 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Gene Expression Changes — 841; 1041; 1639; 628 number of regulated genes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fish oil (Dietary_supplement); Placebo (corn oil) (Dietary_supplement)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Gottfried Wilhelm Leibniz Universität Hannover
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gene Expression Changes |
841; 1041; 1639; 628; 320; 436 | — |
| SECONDARY Fatty Acid Composition of Erythrocyte Membranes (Omega-3 Index) |
5.08; 5.27; 4.90; 5.24; 4.78; 5.50 | — |
| SECONDARY Blood Lipids |
194.0; 261.0; 262.2; 184.1; 188.9; 257.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- males, 20-50 years
- non-smokers
- ethnicity: Caucasians
- no medical treatment
- healthy subjects:
- no documented disease
- normal blood lipids (triglyceride 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
- common exclusion criteria like
- 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
Data sourced from ClinicalTrials.gov (NCT01089231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.