HyperlipidemiaPhase 4NCT01089231
Effects of Omega-3 Fatty Acids on the Human Gene Expression
A Phase 4 study testing Fish oil in people with Hyperlipidemia and Healthy, run by Gottfried Wilhelm Leibniz Universität Hannover at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 51 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Healthy
- What is being tested?
- Fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 51 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- males, 20-50 years
- non-smokers
- ethnicity: Caucasians
- no medical treatment
- healthy subjects:
- no documented disease
Show all 13Show fewer
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Gottfried Wilhelm Leibniz University of Hanover
Hanover, Lower Saxony, 30167
About this study
Official title: Effects of Omega-3 Fatty Acids From Fish Oil on the Gene Expression in Healthy Humans and Humans With Hypertriglyceridemia
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.
Read the detailed description
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
- Hyperlipidemia, Healthy
- Being tested
- Fish oil, Placebo (corn oil)
- Keywords
- Hyperlipidemia, coronary heart disease, gene expression, fish oil, DHA, EPA
- Medical subject headings
- Hyperlipidemias, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary 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
Placebo (corn oil)Dietary supplement
corn oil (6 capsules per day)
| Study group | Role | What they receive |
|---|---|---|
| Placebo - healthy subjects | Placebo comparator | Dietary Supplement: corn oil capsules (6 per day) about 3 months Receives: Dietary Supplement: Placebo (corn oil) |
| Placebo - hyperlipedemic subjects | Placebo comparator | Dietary Supplement: corn oil capsules (6 per day) about 3 months Receives: 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 Receives: 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. Receives: Dietary Supplement: Fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Gene expression changes (number of regulated genes)
Secondary outcomes (2)
Fatty Acid Composition of Erythrocyte Membranes (Omega-3 Index)
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.
Measured: baseline and after 12 weeks
Blood Lipids
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.
Measured: baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gottfried Wilhelm Leibniz Universität Hannover
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Sc. Simone Schmidt, Gottfried Wilhelm Leibniz Universität Hannover
- Investigators
- Andreas Hahn, Prof., Study director, Gottfried Wilhelm Leibniz University of Hanover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089231
- Sponsor's protocol ID
- GWLUH-001
- Other IDs
- GWLUH2010
- Status last verified
- Dec 2011
- First submitted
- 17 Mar 2010
- Last updated
- 19 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23241455Schmidt 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.
PubMed 22929118Schmidt 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.
PubMed 22621246
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 Fatty Acids From Fish Oil on the Gene Expression in Healthy Humans and Humans With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT01089231
- Acronym / sponsor ID
- GWLUH-001
- Conditions
- Hyperlipidemia, Healthy
- Keywords
- Hyperlipidemia, coronary heart disease, gene expression, fish oil, DHA, EPA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gottfried Wilhelm Leibniz Universität HannoverUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Posted 2 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo - healthy subjects | Placebo comparator | Dietary Supplement: Placebo (corn oil)Dietary Supplement: corn oil capsules (6 per day) about 3 months |
| Placebo - hyperlipedemic subjects | Placebo comparator | Dietary Supplement: Placebo (corn oil)Dietary Supplement: corn oil capsules (6 per day) about 3 months |
| Fish oil - hyperlipidemic subjects | Experimental | Dietary Supplement: Fish oilDietary 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 | Experimental | Dietary Supplement: Fish oilDietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. |
Who may qualify
- Ages
- 20 to 51 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- males, 20-50 years
- non-smokers
- ethnicity: Caucasians
- no medical treatment
- healthy subjects:
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oilDietary 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 - healthy subjects, Fish oil - hyperlipidemic subjects |
| Placebo (corn oil)corn oil (6 capsules per day) | Dietary supplement | Placebo - healthy subjects, Placebo - hyperlipedemic subjects |
Primary outcome
Gene Expression Changes
Time frame: Gene expression changes (number of regulated genes)
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.
2 secondary outcomes
Fatty Acid Composition of Erythrocyte Membranes (Omega-3 Index)
Time frame: baseline and after 12 weeks
Blood Lipids
Time frame: baseline and after 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23241455Schmidt 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.
- Derived from this study: PubMed 22929118Schmidt 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.
- Derived from this study: PubMed 22621246Schmidt 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.
- web page of the instituteLink provided by the sponsor.
Related trials for Hyperlipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Hahn, Prof. study director
Gottfried Wilhelm Leibniz University of Hanover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fish oil in people with Hyperlipidemia and Healthy, run by Gottfried Wilhelm Leibniz Universität Hannover at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Expression Changes (time frame: Gene expression changes (number of regulated genes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01089231, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2011.