NCT00955227

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. 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

Conditions

• Hypercholesterolemia
• Hyperlipidemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-05-01
• Completion: 2015-12-01
• First posted: 2009-08-10
• Last updated: 2016-05-12

Locations

2 sites across 1 country: Canada