Overview

This trial is active, not recruiting.

Conditions hypercholesterolemia, hyperlipidemia
Treatments flax seed oil (ala), ezetimibe
Sponsor University of Manitoba
Collaborator Canadian Institutes of Health Research (CIHR)
Start date July 2009
End date May 2011
Trial size 60 participants
Trial identifier NCT00955227, B2009:054

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(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.
(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.
ezetimibe
In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks
(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.
flax seed oil (ala) Jamieson Flax seed oil (ALA)- capsules.
2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks
(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.
flax seed oil (ala) Jamieson Flax seed oil (ALA)- capsules.
2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks
ezetimibe
In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks

Primary Outcomes

Measure
Levels of circulating omega-3 fatty acid (ALA)
time frame: 6 weeks after enrollment of patient

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels
Principal investigator Davinder Jassal
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Manitoba.