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Portfolio 5 - Multicentre

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
David Jenkins, University of Toronto
ClinicalTrials.gov Identifier:
NCT00438425
First received: February 21, 2007
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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 demonstrated, then diet may again be seen as providing an alternative to drug therapy in the primary prevention of cardiovascular disease.

Aims:

  • To determine the percentage of lipid clinic attendees interested in making a serious dietary change.
  • To determine the extent to which a self selected dietary portfolio combining viscous fiber foods (oat & barley β-glucan, psyllium, etc.), soy and vegetable protein foods (soy milk, soy meat analogues and almonds) and plant sterols (sterol margarine) in the same diet be significantly more effective in reducing LDL-cholesterol and other markers of cardiovascular disease risk than conventional dietary advice.
  • To determine whether this effect can be maximized by more frequent follow-up, and what, if any, would be the relationship between dietary compliance and reduction in LDL-C.

Condition Intervention Phase
Hyperlipidemia
Cardiovascular Disease
Behavioral: Effects of a self-selected dietary portfolio on cholesterol reduction
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Assessment of the Practical Application, Acceptability and Effectiveness of a Portfolio Diet in Reducing Serum Cholesterol

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Estimated Enrollment: 220
Study Start Date: January 2007
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438425

Locations
Canada, British Columbia
Healthy Heart Program, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, Canada, R3T 6C5
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Institute on Nutraceuticals and Functional Foods and the Lipid Research Center, Laval University Hospital Research Center
Quebec City, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: David J.A. Jenkins, MD, PhD University of Toronto, St. Michael's Hospital
Study Director: Cyril W.C. Kendall, PhD University of Toronto, St. Michael's Hospital
Study Chair: Dorothea Faulkner, PhD St. Michael's Hospital, Toronto
Study Director: Benoit Lamarche, PhD Lipid Research Clinic & Institute on Nutraceuticals and Functional Foods, Laval University
Study Director: Peter Jones, PhD Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Study Director: Jiri Frohlich, MD Healthy Heart Program, St. Paul's Hospital, Vancouver BC.
Study Director: Jay Silverberg, MD Sunnybrooke Health Science Centre
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Jenkins, Principle Investigator, University of Toronto
ClinicalTrials.gov Identifier: NCT00438425     History of Changes
Other Study ID Numbers: REB 04-056c, CIHR RCT#: 68767
Study First Received: February 21, 2007
Last Updated: June 12, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Toronto:
Hyperlipidemia
Hypercholesterolemia
Dietary modification
Portfolio

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2014