Hypercholesterolemia, Hyperlipidemia
Conditions
Keywords
Omega-3 Fatty acid, ALA (alpha linolenic acid), Ezetimibe, Flaxseed oil capsules
Brief 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
Interventions
DIETARY_SUPPLEMENTFlax seed oil (ALA)
2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks
DRUGEzetimibe
In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks
Sponsors
Canadian Institutes of Health Research (CIHR)
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of circulating omega-3 fatty acid (ALA) | 6 weeks after enrollment of patient |
Secondary
| Measure | 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 |
Countries
Canada
Outcome results
None listed