Effects of a Long Term Dietary Portfolio and of Sequential Removal of Food Components From the Diet

Cardiovascular Diseases Clinical Trial

Official title:

The Long-Term Effect of Viscous Fibers, Soy Protein, and Plant Sterol Foods in Combination on Serum Cholesterol and Other Risk Factors for Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438893
• Other study ID #: REB 03-043
• Secondary ID: HC-CT#100934
• Status: Completed
• Phase: N/A
• Start date: September 1, 2003
• Est. completion date: May 2009

Study information

• Verified date: October 2018
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the long term effectiveness of the dietary portfolio, consisting of viscous fibers, soy products, nuts and plant sterols, as well as the effects of removing single food components from the dietary portfolio on cholesterol reduction and other cardiovascular risk factors.

Description:

We have shown in 1-month metabolic studies that a dietary portfolio, consisting of soy products, viscous fibers, almonds and plant sterols in the form of margarine, can lower cholesterol to the same extent as first generation statins (cholesterol-lowering drugs). However, the long-term effectiveness of the dietary portfolio is not known. Furthermore, it is not known to what extent each of the food components contribute to the cholesterol reductions observed. We wish to therefore evaluate the long term effects of the dietary portfolio as well as the effects of removing single food components from the dietary portfolio on cholesterol reduction and other cardiovascular risk factors. We believe the removal of single food components will result in a reduction of the cholesterol-lowering effect to a similar extent as predicted with the cholesterol reductions observed when the food component is consumed alone.

Method:

66 subjects will be recruited for a 6-month to 5 year long-term dietary portfolio study with the option for continuation (re-consenting) at the end of 6, 12 or 24 months. The active dietary components consist of viscous fibers (including oat bran), soy products (including soy milk), almonds and plant sterols (sterol-enriched margarine). Lipids, blood pressure, body weight, and routine biochemical and hematology analyses will be performed over the 5 year period, with lipids and blood pressure measured at 2 monthly intervals. 40-50 subjects on the long term dietary portfolio study, all of whom will have been on the diet for at least 1 year, will be asked to remove a specific food component from their regular dietary portfolio for a 10 week period. After the 10 week period, subjects will be asked return to the normal dietary portfolio with all food components consumed and continue on the long-term dietary portfolio.

Bloods will be taken at weeks 0, 6 and 10 of the food component removal period; and at 2-monthly intervals for 20 weeks prior to and after the 10 week period while on the long-term dietary portfolio with all food components.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Healthy adult men and postmenopausal women currently enrolled in the long-term portfolio study

• Body mass index <32 kg/m2

• Constant body weight over last 6 months preceding the onset of the study

• Fasting LDL-cholesterol concentration >4.1 mmol/L at diagnosis

Exclusion Criteria:

• women of child-bearing potential

• major cardiovascular event (stroke or myocardial infarction)

• positive molecular diagnosis of familial hypercholesterolemia

• secondary causes of hypercholesterolemia (hypothyroidism, unless treated & on a stable dose of L-thyroxine, renal or liver disease)

• use of cholesterol-lowering medications

• serum triglycerides >4.5 mmol/L

• blood pressure > 145/90 mmHg

• diabetes and/or major disorders such as liver disease, renal failure or cancer

• major surgery <6 months prior to randomization

• alcohol consumption >2 drinks per day

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Dietary portfolio of cholesterol-lowering foods
A plant based dietary portfolio providing plant sterols (1.0g/1000 kcal), soy protein (22.5g/1000 kcal, viscous fibers 10 g/1000 kcal and almonds 22.5g/1000 kcal)

Locations

Country	Name	City	State
Canada	Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre	Toronto	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
University of Toronto	Almond Board of California, Canada Research Chairs Endowment of the Federal Government of Canada, Loblaw Companies Limited, Natural Sciences and Engineering Research Council, Canada, Unilever R&D

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Jenkins DJ, Kendall CW, Faulkner D, Vidgen E, Trautwein EA, Parker TL, Marchie A, Koumbridis G, Lapsley KG, Josse RG, Leiter LA, Connelly PW. A dietary portfolio approach to cholesterol reduction: combined effects of plant sterols, vegetable proteins, and viscous fibers in hypercholesterolemia. Metabolism. 2002 Dec;51(12):1596-604. — View Citation

Jenkins DJ, Kendall CW, Faulkner DA, Nguyen T, Kemp T, Marchie A, Wong JM, de Souza R, Emam A, Vidgen E, Trautwein EA, Lapsley KG, Holmes C, Josse RG, Leiter LA, Connelly PW, Singer W. Assessment of the longer-term effects of a dietary portfolio of choles — View Citation

Jenkins DJ, Kendall CW, Marchie A, Faulkner D, Vidgen E, Lapsley KG, Trautwein EA, Parker TL, Josse RG, Leiter LA, Connelly PW. The effect of combining plant sterols, soy protein, viscous fibers, and almonds in treating hypercholesterolemia. Metabolism. 2003 Nov;52(11):1478-83. — View Citation

Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Lapsley KG, Trautwein EA, Josse RG, Leiter LA, Connelly PW. Effects of a dietary portfolio of cholesterol-lowering foods vs lovastatin on serum lipids and C-reactive protein. JAMA. 2003 Jul 23;290(4):502-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol		At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
Primary	LDL cholesterol		At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
Primary	C-reactive protein		At weeks 0, 12, 24, 34, 52; then every 6 months to a total of 5 years
Primary	Blood pressure		At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
Secondary	Body Weight		At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
Secondary	Apolipoprotein A1 and B		At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
Secondary	Lp(a)		At weeks 0, 24, 52; then every 6 months to a total of 5 years
Secondary	Routine Biochemistry and hematology measurements		At week 0, 12, 24 and every 6 months to 5 years
Secondary	Compliance to dietary portfolio components		At years, 1, 2, 3, 4 and 5
Secondary	24 hour urinary markers and electrolytes (optional)		At week 0 and end of years 1, 2, 3, 4 and 5
Secondary	Oxidative stress markers		week 0 and every 6 months to 5 years