Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels

Study Overview
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Brief Summary
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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
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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

Official Title
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Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels

Conditions
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Hypercholesterolemia, Hyperlipidemia

Intervention / Treatment
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* Dietary Supplement: Flax seed oil (ALA)
* Drug: Ezetimibe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: The subject had been taking flax oil in the last month The subject is not willing to undergo dietary restrictions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Statins only<br>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. | |
| Active Comparator: Statins and ezetimibe<br>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. | Drug: Ezetimibe<br>* In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks<br>|
| Experimental: Statins and flax oil only<br>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. | Dietary Supplement: Flax seed oil (ALA)<br>* 2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks<br>* Other names: Jamieson Flax seed oil (ALA)- capsules.;|
| Experimental: Statins and ezetimibe and flax oil<br>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. | Dietary Supplement: Flax seed oil (ALA)<br>* 2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks<br>* Other names: Jamieson Flax seed oil (ALA)- capsules.;Drug: Ezetimibe<br>* In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of circulating omega-3 fatty acid (ALA) |  | 6 weeks after enrollment of patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The n6:n3 fatty acid ratio will be calculated Total cholesterol, LDL, HDL, and triglyceride levels will also be measured |  | 6 weeks after patient enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3 Fatty acid, ALA (alpha linolenic acid), Ezetimibe, Flaxseed oil capsules