Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Levels of circulating omega-3 fatty acid (ALA)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •The subject had been taking flax oil in the last month
- •The subject is not willing to undergo dietary restrictions
研究组 & 干预措施
Statins and ezetimibe
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.
干预措施: Ezetimibe (Drug)
Statins and flax oil only
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.
干预措施: Flax seed oil (ALA) (Dietary Supplement)
Statins and ezetimibe and flax oil
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.
干预措施: Flax seed oil (ALA) (Dietary Supplement)
Statins and ezetimibe and flax oil
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.
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Levels of circulating omega-3 fatty acid (ALA)
时间窗: 6 weeks after enrollment of patient
次要结局
- 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)
研究者
Dr. Grant Pierce
Professor
University of Manitoba