The effect of a combination of dietary factors (viscous fibers, vegetable proteins and plant sterols) on cholesterol reduction in hyperlipidemic subjects

ISRCTN ISRCTN72726593
DOI https://doi.org/10.1186/ISRCTN72726593
Secondary identifying numbers MCT-68767
Submission date
10/08/2005
Registration date
10/08/2005
Last edited
27/10/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Cyril W.C. Kendall
Scientific

University of Toronto
Department of Nutritional Sciences
Faculty of Medicine
150 College Street
FitzGerald Building, Room 340
Toronto, Ontario
M5S 3E2
Canada

Phone +1 416 978 6527
Email cyril.kendall@utoronto.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleThe effect of a combination of dietary factors (viscous fibers, vegetable proteins and plant sterols) on cholesterol reduction in hyperlipidemic subjects
Study objectivesLowering foods is more effective than current conventional low saturated fat diets.
Ethics approval(s)St Michael's Hospital - Research Ethics Board, 16/09/2004
Health condition(s) or problem(s) studiedHypercholesterolemia
InterventionTest 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Viscous fibers, vegetable proteins and plant sterols
Primary outcome measureLDL-cholesterol
Secondary outcome measuresTotal: 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 study start date01/10/2005
Completion date30/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants330
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2005
Date of final enrolment30/09/2007

Locations

Countries of recruitment

  • Canada

Study participating centre

University of Toronto
Toronto, Ontario
M5S 3E2
Canada

Sponsor information

University of Toronto (Canada)
University/education

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

ROR logo "ROR" https://ror.org/03dbr7087

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-68767)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/01/2008 27/10/2021 Yes No

Editorial Notes

27/10/2021: Publication reference added.