Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/08/2005
Date assigned
10/08/2005
Last edited
10/07/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University of Toronto (Canada)

Sponsor details

27 King's College Circle
Toronto
Ontario
M5S 1A1
Canada

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes