Status:
COMPLETED
Lipoprotein Turnover on Low- and High-MUFA Portfolio Diets
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Hyperlipidemia
Cardiovascular Diseases
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
Brief Summary
Low and very low carbohydrate diets, such as the Atkins' Diet, have recently gained attention for their potential health benefits from weight loss and have gained some scientific support from a growin...
Detailed Description
All subjects will undergo two parallel 2-phase treatments. On one treatment, subjects will be placed on a low fat diet for one month (control run-in diet) and then for the second month will continue o...
Eligibility Criteria
Inclusion
- men and postmenopausal women
- Body mass index \> 18.5 kg/m2 and \< 40 kg/m2
- Fasting plasma triglyceride (TG) concentration \> 2.5 mmol/l and \< 6.0 mmol/l at recruitment.
- Fasting plasma LDL cholesterol concentration \> 3.4 mmol/l at recruitment.
- Fasting plasma HDL cholesterol concentration \< 1.0 mmol/l at recruitment.
- living within a 40 km radius of St. Michael's Hospital.
Exclusion
- Premenopausal women will be excluded due to the fluctuation of blood lipids during the menstrual cycle and the difficulty of synchronising the timing of three one month studies with the same point in the menstrual cycle.
- 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 (or cholesterol lowering natural health products) may join the study providing the medications (or natural health products) are stopped for at least 2 weeks before starting 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 greater than 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.
- Changing the type or dose of their drug treatment during the study.
- Those 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.
- Food allergies
- Evidence or history of diabetes, renal liver disease or gastrointestinal disease. Patients will be excluded if they have gross xanthoma or advanced premature cardiovascular disease since this group may include hyperabsorbers of plant sterols.
- Patients with major cardiovascular event (stroke or myocardial infarction), with secondary causes of hypercholesterolemia (or untreated hypothyroidism), with uncontrolled blood pressure, major disability or disorder such as liver disease, renal failure or with major surgery \< 6 months prior to randomization. Individuals predisposed to hemorrhagic stroke (on the basis of untreated raised blood pressure) will also be excluded.
- Antibiotic use within the last three months.
- Hormone replacement therapy.
- Smokers or have significant alcohol intake (\>1 drink/d).
- Disallowed medications will be cholesterol lowering drugs which if prescribed by patients' physicians while on the study will be a reason for discontinuation from the study. Introduction of cholesterol lowering natural health products during the study will also be a reason for withdrawing a participant from the study.
- individuals with acute (\<6 weeks) or chronic (\>6 weeks) infections, either bacterial or viral, or individuals suffering from chronic inflammatory diseases
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00430430
Start Date
April 1 2007
End Date
April 1 2009
Last Update
October 27 2016
Active Locations (1)
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1
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2