Contact information
Type
Scientific
Primary contact
Dr Cyril W.C. Kendall
ORCID ID
Contact details
University of Toronto
Department of Nutritional Sciences
Faculty of Medicine
150 College Street
FitzGerald Building
Room 340
Toronto
Ontario
M5S 3E2
Canada
+1 416 978 6527
cyril.kendall@utoronto.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-68767
Study information
Scientific title
Acronym
Study hypothesis
Lowering foods is more effective than current conventional low saturated fat diets.
Ethics approval
St Michael's Hospital - Research Ethics Board, 16/09/2004
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Hypercholesterolemia
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Viscous fibers, vegetable proteins and plant sterols
Primary outcome measures
LDL-cholesterol
Secondary outcome measures
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
Overall trial start date
01/10/2005
Overall trial end date
30/09/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
330
Participant exclusion criteria
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
Recruitment start date
01/10/2005
Recruitment end date
30/09/2007
Locations
Countries of recruitment
Canada
Trial participating centre
University of Toronto
Toronto, Ontario
M5S 3E2
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-68767)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary