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

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

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.

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

Intervention(s) in this Clinical Trial

• Dietary Supplement: Flax seed oil (ALA)
  • 2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks
• Drug: Ezetimibe
  • In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: Statins only
  • 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
  • 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.
• Experimental: Statins and flax oil only
  • 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.
• Experimental: Statins and ezetimibe and flax oil
  • 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.

Primary Measures

• Levels of circulating omega-3 fatty acid (ALA)
  • Time Frame: 6 weeks after enrollment of patient
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Manitoba Other

Overall Clinical Trial Officials and Contacts

Grant N Pierce, PhD Study Director St. Boniface General Hospital Research Centre  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00955227

Study ID Number: B2009:054

ClinicalTrials.gov Identifier: NCT00955227

Health Authority: Canada: Canadian Institutes of Health Research