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OpenTrials
Completed

NCT Number: NCT00955227

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface General Hospital, Winnipeg, Manitoba, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flax seed oil (ALA)

Dietary Supplement

2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks

Other names: Jamieson Flax seed oil (ALA)- capsules.

ezetimibe

Drug

In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks

Primary outcomes

  1. Levels of circulating omega-3 fatty acid (ALA)

    Time frame: 6 weeks after enrollment of patient

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2015
First posted
Aug 10, 2009
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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