Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Sep 2003

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.7 years study duration

Study Start

First participant enrolled

September 1, 2003

Completed

3.5 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed

Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

5.7 years

First QC Date

February 20, 2007

Last Update Submit

October 10, 2018

Conditions

Hyperlipidemia Cardiovascular Diseases Hypercholesterolemia

Keywords

Viscous dietary fiberSoy proteinNutsPlant sterolsDietary PortfolioComplianceBlood lipidsBlood pressure

Outcome Measures

Primary Outcomes (4)

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 Outcomes (7)

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
+2 more secondary outcomes

Study Arms (1)

A portfolio of cholesterol-lowering foods

OTHER

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

Dietary Supplement: Dietary portfolio of cholesterol-lowering foods

Interventions

Dietary portfolio of cholesterol-lowering foodsDIETARY_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)

A portfolio of cholesterol-lowering foods

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Torontolead
Canada Research Chairs Endowment of the Federal Government of Canadacollaborator
Natural Sciences and Engineering Research Council, Canadacollaborator
Loblaw Companies Limitedcollaborator
Almond Board of Californiacollaborator
Unilever R&Dcollaborator

Study Sites (1)

Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (5)

Jenkins DJ, Kendall CW, Faulkner D, Vidgen E, Trautwein EA, Parker TL, Marchie A, Koumbridis G, Lapsley KG, Josse RG, Leiter LA, Connelly PW. A dietary portfolio approach to cholesterol reduction: combined effects of plant sterols, vegetable proteins, and viscous fibers in hypercholesterolemia. Metabolism. 2002 Dec;51(12):1596-604. doi: 10.1053/meta.2002.35578.
PMID: 12489074BACKGROUND
Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Lapsley KG, Trautwein EA, Josse RG, Leiter LA, Connelly PW. Effects of a dietary portfolio of cholesterol-lowering foods vs lovastatin on serum lipids and C-reactive protein. JAMA. 2003 Jul 23;290(4):502-10. doi: 10.1001/jama.290.4.502.
PMID: 12876093BACKGROUND
Jenkins DJ, Kendall CW, Marchie A, Faulkner D, Vidgen E, Lapsley KG, Trautwein EA, Parker TL, Josse RG, Leiter LA, Connelly PW. The effect of combining plant sterols, soy protein, viscous fibers, and almonds in treating hypercholesterolemia. Metabolism. 2003 Nov;52(11):1478-83. doi: 10.1016/s0026-0495(03)00260-9.
PMID: 14624410BACKGROUND
Jenkins DJ, Kendall CW, Faulkner DA, Nguyen T, Kemp T, Marchie A, Wong JM, de Souza R, Emam A, Vidgen E, Trautwein EA, Lapsley KG, Holmes C, Josse RG, Leiter LA, Connelly PW, Singer W. Assessment of the longer-term effects of a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia. Am J Clin Nutr. 2006 Mar;83(3):582-91. doi: 10.1093/ajcn.83.3.582.
PMID: 16522904RESULT
Jenkins DJ, Kendall CW, Nguyen TH, Marchie A, Faulkner DA, Ireland C, Josse AR, Vidgen E, Trautwein EA, Lapsley KG, Holmes C, Josse RG, Leiter LA, Connelly PW, Singer W. Effect of plant sterols in combination with other cholesterol-lowering foods. Metabolism. 2008 Jan;57(1):130-9. doi: 10.1016/j.metabol.2007.08.016.
PMID: 18078870DERIVED

MeSH Terms

Conditions

HyperlipidemiasCardiovascular DiseasesHypercholesterolemiaPatient Compliance

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

David JA Jenkins, MD, PhD, DSc
Department of Nutritional Sciences, Faculty of Medicine, University of Toronto
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principle Investigator

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

September 1, 2003

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations

CA(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (7)

Study Arms (1)

A portfolio of cholesterol-lowering foods

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations