Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels

NCT ID: NCT00955227

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2015-12-31

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

Conditions

Hypercholesterolemia; Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Statins only

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Ezetimibe

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Flax seed oil (ALA)

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: EXPERIMENTAL

Flax seed oil (ALA)

Intervention Type: DIETARY_SUPPLEMENT

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

Ezetimibe

Intervention Type: DRUG

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

Interventions

Flax seed oil (ALA)

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

Intervention Type: DIETARY_SUPPLEMENT

Ezetimibe

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

Intervention Type: DRUG

Other Intervention Names

Jamieson Flax seed oil (ALA)- capsules.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Grant Pierce

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grant N Pierce, PhD

Role: STUDY_DIRECTOR

St. Boniface Hospital

Davinder Jassal

Role: PRINCIPAL_INVESTIGATOR

St. Boniface Hospital

Locations

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

St. Boniface General Hospital Research Centre

Winnipeg, Manitoba, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28531469 (View on PubMed)

Other Identifiers

B2009:054

Identifier Type: -

Identifier Source: org_study_id