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 |
| Protocol serial number | MCT-68767 |
| Sponsor | University of Toronto (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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
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 |
|---|---|
| cyril.kendall@utoronto.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effect of a combination of dietary factors (viscous fibers, vegetable proteins and plant sterols) on cholesterol reduction in hyperlipidemic subjects |
| Study objectives | Lowering 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) studied | 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 / device / biological / vaccine name(s) | Viscous fibers, vegetable proteins and plant sterols |
| Primary outcome measure(s) |
LDL-cholesterol |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 330 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
University of Toronto
Toronto, Ontario
M5S 3E2
Canada
M5S 3E2
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not 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.
