Status:
COMPLETED
Portfolio 5 - Multicentre Dietary Advice on Serum Lipids in Hyperlipidemia
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Loblaw Companies Limited
Conditions:
Hyperlipidemia
Cardiovascular Disease
Eligibility:
All Genders
21-100 years
Phase:
NA
Brief Summary
The purpose of this trial is to re-evaluate the potential role of diet in modulating cardiovascular risk factors. If potent lipid-lowering effects through novel dietary interventions can be demonstrat...
Detailed Description
This is a randomized parallel study with three experimental arms of 6 months duration to estimate the effect of the portfolio diet under real world conditions at two levels of advice intensity. Every ...
Eligibility Criteria
Inclusion
- Men over the age of 21 years and postmenopausal women with mild-to-moderate hypercholesterolaemia, for whom cholesterol lowering medications are being considered
- Body mass index \<35 kg/m2.
- Treated by diet
- Alcohol intake \< 14 drinks per week.
- Fasting plasma triglyceride (TG) concentration \<4.5 mmol/l.
- Fasting plasma LDL cholesterol concentration \> 4.1 mmol/l at diagnosis or within 30% of their target levels based on risk
- Patients with previous adverse effects on statins (e.g. muscle pains) will also be accepted if the physician responsible for their care considers it appropriate.
- Individuals who prior to cholesterol lowering therapy or after discontinuing cholesterol lowering therapy are within 30% of their treatment LDL-C goals may be permitted to enter the study with the approval of their responsible physician.
- Fit individuals who have had a myocardial infarction or cardiac bypass surgery in the past will not be excluded. Their responsible physician will be asked to provide a letter confirming their suitability for the study.
Exclusion
- Premenopausal women will be excluded due to the fluctuation of blood lipids during the menstrual cycle.
- Patients will be excluded if they are taking cholesterol medications at the start of the study. However, with their physician's approval, those who wish to join but are already taking cholesterol-lowering medications may join the study providing the medications are stopped for one month before starting the study and throughout the study.
- Patients will be excluded if they are taking cholesterol lowering natural health products such as psyllium, red yeast rice, cholest, polycosanol etc. However, they will be allowed to join the study if they are willing to discontinue these products at least 2 weeks before the start of the study and throughout the study.
- Patients with uncontrolled high blood pressure will be excluded. The cut off for raised blood pressure has been taken as \> 140/90mmHg. Patients with systolic blood pressure between 140-150mmHg and diastolic blood pressure between 90-95mmHg may be accepted, since we have found that on the diet their blood pressures tend to be lowered into the acceptable range. For patients in the above normal range (as above), a letter will be required from the physician responsible for their care. Patients will be excluded if they change the type or dose of their blood pressure treatment during the study.
- Patients will be excluded if they are judged as having a likelihood of being non-compliant with instructions for whatever reason. Those with low compliance to lipid-lowering therapy will not be selected.
- Patients will be excluded if they have evidence or history of diabetes, renal disease, liver disease or gastrointestinal disease. Patients will be excluded if they have gross xanthoma or advanced premature cardiovascular disease since this group may include hyper-absorbers of plant sterols.
- Individuals predisposed to hemorrhagic stroke (on the basis of untreated raised blood pressure) will be excluded.
- Patients will be excluded from the study if they have a history of any form of cancer apart from non melanoma skin cancer or are considered at high risk for cancer. However, if such patients wish to join the study, we would like them to obtain the approval of their oncologist or responsible physician prior to enrollment in the study. If the study oncologist does not believe it is safe to enroll the participant, the patient will be excluded from the study.
Key Trial Info
Start Date :
June 25 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2010
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT00438425
Start Date
June 25 2007
End Date
March 31 2010
Last Update
October 15 2018
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Healthy Heart Program, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
2
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, Canada, R3T 6C5
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
4
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2