NCT00955227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

August 6, 2009

Last Update Submit

May 10, 2016

Conditions

HypercholesterolemiaHyperlipidemia

Keywords

Omega-3 Fatty acidALA (alpha linolenic acid)EzetimibeFlaxseed oil capsules

Outcome Measures

Primary Outcomes (1)

  • Levels of circulating omega-3 fatty acid (ALA)

    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

    6 weeks after patient enrollment

Study Arms (4)

Statins only

NO INTERVENTION

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.

Statins and ezetimibe

ACTIVE COMPARATOR

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

Statins and flax oil only

EXPERIMENTAL

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)

Statins and ezetimibe and flax oil

EXPERIMENTAL

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.

Dietary Supplement: Flax seed oil (ALA)Drug: Ezetimibe

Interventions

Flax seed oil (ALA)DIETARY_SUPPLEMENT

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

Also known as: Jamieson Flax seed oil (ALA)- capsules.
Statins and ezetimibe and flax oilStatins and flax oil only
EzetimibeDRUG

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

Statins and ezetimibeStatins and ezetimibe and flax oil

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The subject had been taking flax oil in the last month
  • The subject is not willing to undergo dietary restrictions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

St. Boniface General Hospital Research Centre

Winnipeg, Manitoba, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28531469DERIVED

MeSH Terms

Conditions

HypercholesterolemiaHyperlipidemias

Interventions

Linseed OilEzetimibe

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Grant N Pierce, PhD

    St. Boniface Hospital

    STUDY DIRECTOR

  • Davinder Jassal

    St. Boniface Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2009

First Posted

August 10, 2009

Study Start

July 1, 2009

Primary Completion

May 1, 2011

Study Completion

December 1, 2015

Last Updated

May 12, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Results in press in 2016 Clinical Nutrition Blackwood et. al

Locations

CA(2)