HypercholesterolemiaNCT00955227
Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels
A study testing Flax seed oil (ALA) and Ezetimibe in people with Hypercholesterolemia and Hyperlipidemia, run by University of Manitoba at 2 sites in Canada.
Trial summary
The objective of this study is to determine if the administration of a cholesterol lowering drug like ezetimibe will reduce circulating omega-3 fatty acid (ALA) levels in patients with heart disease and hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia, Hyperlipidemia
- What is being tested?
- Flax seed oil (ALA) and Ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2009to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is between 18-80 years old
- The subject lives in Winnipeg area
- The subject is willing to seize intake of oils/ salad dressings/ seafood
- The subject is willing to comply with the study schedule
Who cannot join
- The subject had been taking flax oil in the last month
- The subject is not willing to undergo dietary restrictions
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
St. Boniface General Hospital Research Centre
Winnipeg, Manitoba
About this study
The objective of this study is to determine if the administration of a cholesterol lowering drug like ezetimibe will reduce circulating omega-3 fatty acid (ALA) levels in patients with heart disease and hypercholesterolemia.
The investigators hypothesize that their data will discover that patients receiving ezetimibe require additional dietary supplementation with omega-3 supplements to insure that these beneficial fatty acids are available to these patients.
Read the detailed description
All patients will undergo drug therapy as required to treat their clinical symptoms including the use of other classes of cholesterol-lowering drugs like statins (that will not interfere with intestinal cholesterol levels). One group of patients will be those who in addition to there existing drug therapy are prescribed ezetimibe to lower circulating cholesterol concentrations. A second group of patients will be those who are not prescribed ezetimibe as part of their normal course of therapy. Blood samples will be taken from all patients at the study baseline. All patients will be fasted for 12 hours prior to the blood sample being taken. After 6 weeks a second blood sample will be taken. This will determine if the drug intervention (ezetimibe) influenced the circulating omega-3 fatty acid concentration.
It will also be of interest to determine if drug administration (ezetimibe) will influence this process when higher levels of omega-3 fatty acids are given to the patients by dietary supplements of ALA. Two additional groups of patients will consume a flaxseed oil supplement containing 1g of ALA in the form of two capsules daily
- Conditions
- Hypercholesterolemia, Hyperlipidemia
- Being tested
- Flax seed oil (ALA), Ezetimibe
- Keywords
- Omega-3 Fatty acid, ALA (alpha linolenic acid), Ezetimibe, Flaxseed oil capsules
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flax seed oil (ALA)Dietary supplement
Also called Jamieson Flax seed oil (ALA)- capsules.
2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks
EzetimibeDrug
In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Statins only | No intervention | In this arm- 15 Patients with heart disease and hypercholesterolemia will receive standard statin treatment as determined by the Cardiologist. Patients in this arm will be excluded if they are on ezetimibe. |
| Statins and ezetimibe | Active comparator | In this arm- 15 Patients with heart disease and hypercholesterolemia will receive standard statin treatment as determined by the Cardiologist. In addition, these patients will be on ezetimibe. Receives: Drug: Ezetimibe |
| Statins and flax oil only | Experimental | In this arm- 15 Patients receiving standard statin treatment as determined by their cardiologist will also receive two flaxseed oil capsules/day each containing 500 mg of ALA. Receives: Dietary Supplement: Flax seed oil (ALA) |
| Statins and ezetimibe and flax oil | Experimental | In this arm- 15 Patients with heart disease and hypercholesterolemia that are on standard statin treatment as determined by their cardiologist, will also receive (as an intervention) ezetimibe and flaxseed oil capsules containing 500mg of ALA. Receives: Dietary Supplement: Flax seed oil (ALA); Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of circulating omega-3 fatty acid (ALA)
Measured: 6 weeks after enrollment of patient
Secondary outcomes (1)
The n6:n3 fatty acid ratio will be calculated Total cholesterol, LDL, HDL, and triglyceride levels will also be measured
Measured: 6 weeks after patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2011
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Grant Pierce, University of Manitoba
- Investigators
- Grant N Pierce, PhD, Study director, St. Boniface HospitalDavinder Jassal, Principal investigator, St. Boniface Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955227
- Sponsor's protocol ID
- B2009:054
- Status last verified
- May 2016
- First submitted
- 6 Aug 2009
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Results in press in 2016 Clinical Nutrition Blackwood et. al
Publications
Blackwood DP, LaVallee RK, Al Busaidi A, Jassal DS, Pierce GN. A randomized trial of the effects of ezetimibe on the absorption of omega-3 fatty acids in cardiac disease patients: A pilot study. Clin Nutr ESPEN. 2015 Oct;10(5):e155-e159. doi: 10.1016/j.clnesp.2015.07.002. Epub 2015 Aug 28.
PubMed 28531469
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels
- ClinicalTrials.gov ID
- NCT00955227
- Acronym / sponsor ID
- B2009:054
- Conditions
- Hypercholesterolemia, Hyperlipidemia
- Keywords
- Omega-3 Fatty acid, ALA (alpha linolenic acid), Ezetimibe, Flaxseed oil capsules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine if the administration of a cholesterol lowering drug like ezetimibe will reduce circulating omega-3 fatty acid (ALA) levels in patients with heart disease and hypercholesterolemia.
The investigators hypothesize that their data will discover that patients receiving ezetimibe require additional dietary supplementation with omega-3 supplements to insure that these beneficial fatty acids are available to these patients.
Detailed description
All patients will undergo drug therapy as required to treat their clinical symptoms including the use of other classes of cholesterol-lowering drugs like statins (that will not interfere with intestinal cholesterol levels). One group of patients will be those who in addition to there existing drug therapy are prescribed ezetimibe to lower circulating cholesterol concentrations. A second group of patients will be those who are not prescribed ezetimibe as part of their normal course of therapy. Blood samples will be taken from all patients at the study baseline. All patients will be fasted for 12 hours prior to the blood sample being taken. After 6 weeks a second blood sample will be taken. This will determine if the drug intervention (ezetimibe) influenced the circulating omega-3 fatty acid concentration.
It will also be of interest to determine if drug administration (ezetimibe) will influence this process when higher levels of omega-3 fatty acids are given to the patients by dietary supplements of ALA. Two additional groups of patients will consume a flaxseed oil supplement containing 1g of ALA in the form of two capsules daily
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Statins only | No intervention | –In this arm- 15 Patients with heart disease and hypercholesterolemia will receive standard statin treatment as determined by the Cardiologist. Patients in this arm will be excluded if they are on ezetimibe. |
| Statins and ezetimibe | Active comparator | Drug: EzetimibeIn this arm- 15 Patients with heart disease and hypercholesterolemia will receive standard statin treatment as determined by the Cardiologist. In addition, these patients will be on ezetimibe. |
| Statins and flax oil only | Experimental | Dietary Supplement: Flax seed oil (ALA)In this arm- 15 Patients receiving standard statin treatment as determined by their cardiologist will also receive two flaxseed oil capsules/day each containing 500 mg of ALA. |
| Statins and ezetimibe and flax oil | Experimental | Dietary Supplement: Flax seed oil (ALA), Drug: EzetimibeIn this arm- 15 Patients with heart disease and hypercholesterolemia that are on standard statin treatment as determined by their cardiologist, will also receive (as an intervention) ezetimibe and flaxseed oil capsules containing 500mg of ALA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject is between 18-80 years old
- The subject lives in Winnipeg area
- The subject is willing to seize intake of oils/ salad dressings/ seafood
- The subject is willing to comply with the study schedule
Key exclusion criteria (2 listed)
- The subject had been taking flax oil in the last month
- The subject is not willing to undergo dietary restrictions
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 |
|---|---|---|
| Flax seed oil (ALA)Also: Jamieson Flax seed oil (ALA)- capsules.2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks | Dietary supplement | Statins and ezetimibe and flax oil, Statins and flax oil only |
| EzetimibeIn total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks | Drug | Statins and ezetimibe, Statins and ezetimibe and flax oil |
Primary outcome
Levels of circulating omega-3 fatty acid (ALA)
Time frame: 6 weeks after enrollment of patient
1 secondary outcome
The n6:n3 fatty acid ratio will be calculated Total cholesterol, LDL, HDL, and triglyceride levels will also be measured
Time frame: 6 weeks after patient enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Derived from this study: PubMed 28531469Blackwood DP, LaVallee RK, Al Busaidi A, Jassal DS, Pierce GN. A randomized trial of the effects of ezetimibe on the absorption of omega-3 fatty acids in cardiac disease patients: A pilot study. Clin Nutr ESPEN. 2015 Oct;10(5):e155-e159. doi: 10.1016/j.clnesp.2015.07.002. Epub 2015 Aug 28.
- Individual participant dataSharing planned: Yes. Results in press in 2016 Clinical Nutrition Blackwood et. al
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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.
Grant N Pierce, PhD study director
St. Boniface Hospital
Davinder Jassal principal investigator
St. Boniface Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flax seed oil (ALA) and Ezetimibe in people with Hypercholesterolemia and Hyperlipidemia, run by University of Manitoba at 2 sites in Canada.
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 4 inclusion and 2 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Levels of circulating omega-3 fatty acid (ALA) (time frame: 6 weeks after enrollment of patient). 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 NCT00955227, which also lists 1 linked publication.
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 12 May 2016.