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

October 10, 2018 updated by: David Jenkins, University of Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A portfolio of cholesterol-lowering foods
Dietary advice to consume a dietary portfolio of cholesterol-lowering foods
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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

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

Investigators

  • Principal Investigator: David JA Jenkins, MD, PhD, DSc, Department of Nutritional Sciences, Faculty of Medicine, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2003

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 22, 2007

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB 03-043
  • HC-CT#100934

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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