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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-01

Study Completion Date

2009-05-31

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.

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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.

Conditions

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Hyperlipidemia Cardiovascular Diseases Hypercholesterolemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A portfolio of cholesterol-lowering foods

Dietary advice to consume a dietary portfolio of cholesterol-lowering foods

Group Type OTHER

Dietary portfolio of cholesterol-lowering foods

Intervention Type DIETARY_SUPPLEMENT

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)

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes