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ISRCTN
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ISRCTN72726593
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ClinicalTrials.gov identifier
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Public title
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The effect of a combination of dietary factors (viscous fibers, vegetable proteins and plant sterols) on cholesterol reduction in hyperlipidemic subjects
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Scientific title
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Acronym
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N/A
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Serial number at source
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MCT-68767
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Study hypothesis
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Lowering foods is more effective than current conventional low saturated fat diets.
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Lay summary
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Ethics approval
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St Michael's Hospital - Research Ethics Board, 16/09/2004
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Hypercholesterolemia
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Participants - inclusion criteria
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1. 330 persons with hiperlipidemia of both sex, age groups 18 and older
2. Men and post menopausal women with Low-Density Lipoprotein (LDL)-cholesterol levels within 30% of their target goals who are prepared to make a serious commitment to dietary change
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Participants - exclusion criteria
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1. Body mass index (BMI) >32 kg/m^2
2. Recent weight loss or gain
3. Recent stroke
4. Myocardial Infarction (MI)
5. Familial hypercholesterolemia, secondary causes of hypercholesterolemia (e.g. hypothyroidism unless treated, renal or liver disease)
6. Cholesterol lowering medications
7. Triglyceride (TG) less than 4.5, blood pressure (BP) more than 145/90
8. Diabetes or major disability or disease, including liver disease, renal failure or cancer
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Anticipated start date
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01/10/2005
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Anticipated end date
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30/09/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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330
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Interventions
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Test group: soy foods, viscous fiber foods (oats and barley etc.), almonds and other nuts, plant sterol margarine prescribed as routine advice or intensive advice
Control group: low saturated fat, high fruit, vegetables and whole grain cereal advice
For further information, please contact the principal investigator Prof David Jenkins or the principal co-investigator Dr Cyril Kendall at the address listed below.
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Primary outcome measure(s)
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LDL-cholesterol
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Secondary outcome measure(s)
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Total: High-Density Lipoprotein (HDL) cholesterol, TG, HDL-C, C-Reactive Protein (CRP), Homocysteine, glucose, insulin, waist circumference, blood pressure (BP), diet composition, body weight, and red cell fragility and plant sterol concentrations
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-68767)
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Trial website
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Publications
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Contact name
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Dr
Cyril W.C.
Kendall
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Address
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University of Toronto
Department of Nutritional Sciences
Faculty of Medicine
150 College Street
FitzGerald Building, Room 340
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City/town
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Toronto, Ontario
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Zip/Postcode
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M5S 3E2
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Country
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Canada
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Tel
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+1 416 978 6527
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Fax
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+1 416 978 5310
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Email
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cyril.kendall@utoronto.ca
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Sponsor
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University of Toronto (Canada)
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Address
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27 King's College Circle
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City/town
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Toronto, Ontario
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Zip/Postcode
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M5S 1A1
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Country
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Canada
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Date applied
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10/08/2005
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Last edited
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10/07/2007
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Date ISRCTN assigned
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10/08/2005
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