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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hypercholesterolemia, Hyperlipidemia, Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Dietary portfolio of cholesterol-lowering foods


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A portfolio of cholesterol-lowering foods<br>Dietary advice to consume a dietary portfolio of cholesterol-lowering foods | Dietary Supplement: Dietary portfolio of cholesterol-lowering foods<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol |  | At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years | 
| LDL cholesterol |  | At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years | 
| C-reactive protein |  | At weeks 0, 12, 24, 34, 52; then every 6 months to a total of 5 years | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight |  | At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years | 
| 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 | 
| Lp(a) |  | At weeks 0, 24, 52; then every 6 months to a total of 5 years | 
| Routine Biochemistry and hematology measurements |  | At week 0, 12, 24 and every 6 months to 5 years | 
| Compliance to dietary portfolio components |  | At years, 1, 2, 3, 4 and 5 | 
| 24 hour urinary markers and electrolytes (optional) |  | At week 0 and end of years 1, 2, 3, 4 and 5 | 
| Oxidative stress markers |  | week 0 and every 6 months to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viscous dietary fiber, Soy protein, Nuts, Plant sterols, Dietary Portfolio, Compliance, Blood lipids, Blood pressure