Clinical trial NCT00955227: Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels
Official title: Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Hyperlipidemia
Keywords: Omega-3 Fatty acid
ALA (alpha linolenic acid)
Ezetimibe
Flaxseed oil capsules
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Eligibility criteria: 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

Primary outcomes:
measure: Levels of circulating omega-3 fatty acid (ALA)
timeFrame: 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
timeFrame: 6 weeks after patient enrollment
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital Research Centre
state: Manitoba
Study officials:
affiliation: St. Boniface Hospital
name: Grant N Pierce, PhD
role: STUDY_DIRECTOR
affiliation: St. Boniface Hospital
name: Davinder Jassal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blackwood DP, LaVallee RK, Al Busaidi A, Jassal DS, Pierce GN. A randomized trial of the effects of ezetimibe on the absorption of omega-3 fatty acids in cardiac disease patients: A pilot study. Clin Nutr ESPEN. 2015 Oct;10(5):e155-e159. doi: 10.1016/j.clnesp.2015.07.002. Epub 2015 Aug 28.