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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canada Research Chairs Endowment of the Federal Government of Canada
Natural Sciences and Engineering Research Council, Canada
Loblaw Companies Limited
Almond Board of California
Unilever R&D
Information provided by (Responsible Party):
David Jenkins, University of Toronto
ClinicalTrials.gov Identifier:
NCT00438893
First received: February 20, 2007
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Cardiovascular Diseases
Hypercholesterolemia
Dietary Supplement: Dietary portfolio of cholesterol-lowering foods
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • C-reactive protein [ Time Frame: At weeks 0, 12, 24, 34, 52; then every 6 months to a total of 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Lp(a) [ Time Frame: At weeks 0, 24, 52; then every 6 months to a total of 5 years ] [ Designated as safety issue: No ]
  • Routine Biochemistry and hematology measurements [ Time Frame: At week 0, 12, 24 and every 6 months to 5 years ] [ Designated as safety issue: Yes ]
  • Compliance to dietary portfolio components [ Time Frame: At years, 1, 2, 3, 4 and 5 ] [ Designated as safety issue: No ]
  • 24 hour urinary markers and electrolytes (optional) [ Time Frame: At week 0 and end of years 1, 2, 3, 4 and 5 ] [ Designated as safety issue: No ]
  • Oxidative stress markers [ Time Frame: week 0 and every 6 months to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: January 2004
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438893

Locations
Canada, Ontario
Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
University of Toronto
Canada Research Chairs Endowment of the Federal Government of Canada
Natural Sciences and Engineering Research Council, Canada
Loblaw Companies Limited
Almond Board of California
Unilever R&D
Investigators
Principal Investigator: David JA Jenkins, MD, PhD, DSc Department of Nutritional Sciences, Faculty of Medicine, University of Toronto
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Jenkins, Principle Investigator, University of Toronto
ClinicalTrials.gov Identifier: NCT00438893     History of Changes
Other Study ID Numbers: REB 03-043, HC-CT#100934
Study First Received: February 20, 2007
Last Updated: July 22, 2013
Health Authority: Canada: St. Michael's Hospital Research Ethics Board
Canada: Natural Health Products Directorate

Keywords provided by University of Toronto:
Viscous dietary fiber
Soy protein
Nuts
Plant sterols
Dietary Portfolio
Compliance
Blood lipids
Blood pressure

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014