Cardiovascular Diseases Clinical Trial
Official title:
Lipoprotein Turnover on Low- and High-MUFA Portfolio Diets
Verified date | October 2016 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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 growing number of studies. Benefits have been noted in relation to
raised "good" cholesterol, lower "bad" cholesterol and triglycerides. Other studies have
shown an advantage in substituting vegetable fat for carbohydrate in insulin resistant
individuals and in some instances in type 2 diabetes where improvements were seen in "good"
cholesterol and blood sugars. At the same time, our research have been exploring diets
containing less processed carbohydrates and other components which in combination (portfolio
diet) have a similar cholesterol lowering effect to drug therapy.
Therefore we wish to determine whether our cholesterol-lowering components (portfolio diet)
should be incorporated into lower carbohydrate diets especially to preserve "good"
cholesterol and lower "bad" cholesterol for decreasing the risk of heart disease.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Risk Factor Modification Centre, St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HDL-C and VLDL-TG, synthesis and fractional catabolic rates of their respective apolipoproteins, apo AI and B100 | 2 months | Yes | |
Secondary | LDL-C, LDL particle size, total and VLDL triglyceride, C-reactive protein, intravascular enzymes, HDL subfractions, blood glucose and insulin (HOMA models S and B), and relation of listed outcomes to kinetic parameters | 2 months | Yes |
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