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

February 20, 2007
July 22, 2013
January 2004
April 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Total cholesterol
  • LDL cholesterol
  • C-reactive protein
  • Blood pressure
Complete list of historical versions of study NCT00438893 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Body Weight
  • Apolipoprotein A1 and B
  • Lp(a)
  • Routine Biochemistry and hematology measurements
  • Compliance to dietary portfolio components
  • 24 hour urinary markers and electrolytes
  • Oxidative stress markers
Not Provided
Not Provided
 
Effects of a Long Term Dietary Portfolio and of Sequential Removal of Food Components From the Diet
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperlipidemia
  • Cardiovascular Diseases
  • Hypercholesterolemia
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)
A portfolio of cholesterol-lowering foods
Dietary advice to consume a dietary portfolio of cholesterol-lowering foods
Intervention: Dietary Supplement: Dietary portfolio of cholesterol-lowering foods

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
66
Not Provided
April 2010   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00438893
REB 03-043, HC-CT#100934
No
David Jenkins, University of Toronto
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
Principal Investigator: David JA Jenkins, MD, PhD, DSc Department of Nutritional Sciences, Faculty of Medicine, University of Toronto
University of Toronto
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP