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

May 10, 2016 updated by: Dr. Grant Pierce, University of Manitoba

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
      • Winnipeg, Manitoba, Canada
        • St. Boniface General Hospital Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.
Drug: Ezetimibe
In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks
Experimental: 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.
Dietary supplement: Flax seed oil (ALA)
2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks
Other Names:
  • Jamieson Flax seed oil (ALA)- capsules.
Experimental: 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.
Drug: Ezetimibe
In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks
Dietary supplement: Flax seed oil (ALA)
2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks
Other Names:
  • Jamieson Flax seed oil (ALA)- capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Levels of circulating omega-3 fatty acid (ALA)
Time Frame: 6 weeks after enrollment of patient
6 weeks after enrollment of patient

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks after patient enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Study Director: Grant N Pierce, PhD, St. Boniface Hospital
  • Principal Investigator: Davinder Jassal, St. Boniface Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2009:054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Results in press in 2016 Clinical Nutrition Blackwood et. al

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypercholesterolemia

Clinical Trials on Ezetimibe

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe