HyperlipidemiaNCT00438893
Effects of a Long Term Dietary Portfolio and of Sequential Removal of Food Components From the Diet
A study testing Dietary portfolio of cholesterol-lowering foods in people with Hyperlipidemia and Cardiovascular Diseases, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Cardiovascular Diseases, Hypercholesterolemia
- What is being tested?
- Dietary portfolio of cholesterol-lowering foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2003to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
Toronto, Ontario, M5C 2T2
About this study
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
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.
Read the 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.
- Being tested
- Dietary portfolio of cholesterol-lowering foods
- Keywords
- Viscous dietary fiber, Soy protein, Nuts, Plant sterols, Dietary Portfolio, Compliance, Blood lipids, Blood pressure
- Medical subject headings
- Hyperlipidemias, Cardiovascular Diseases, Hypercholesterolemia, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| A portfolio of cholesterol-lowering foods | Other | Dietary advice to consume a dietary portfolio of cholesterol-lowering foods Receives: Dietary Supplement: Dietary portfolio of cholesterol-lowering foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
Measured: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
LDL cholesterol
Measured: 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
Measured: At weeks 0, 12, 24, 34, 52; then every 6 months to a total of 5 years
Blood pressure
Measured: 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
Measured: 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
Measured: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
Lp(a)
Measured: At weeks 0, 24, 52; then every 6 months to a total of 5 years
Routine Biochemistry and hematology measurements
Measured: At week 0, 12, 24 and every 6 months to 5 years
Compliance to dietary portfolio components
Measured: At years, 1, 2, 3, 4 and 5
24 hour urinary markers and electrolytes (optional)
Measured: At week 0 and end of years 1, 2, 3, 4 and 5
Oxidative stress markers
Measured: week 0 and every 6 months to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study start1 Sep 2003
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, David Jenkins, University of Toronto
- Investigators
- David JA Jenkins, MD, PhD, DSc, Principal investigator, Department of Nutritional Sciences, Faculty of Medicine, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438893
- Sponsor's protocol ID
- REB 03-043
- Other IDs
- HC-CT#100934
- Status last verified
- Oct 2018
- First submitted
- 20 Feb 2007
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12489074Jenkins 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.
PubMed 12876093Jenkins 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.
PubMed 14624410Jenkins 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.
PubMed 16522904Jenkins 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.
PubMed 18078870
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00438893
- Acronym / sponsor ID
- REB 03-043
- Keywords
- Viscous dietary fiber, Soy protein, Nuts, Plant sterols, Dietary Portfolio, Compliance, Blood lipids, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- 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
- Study start
- 1 Sep 2003 (actual)
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A portfolio of cholesterol-lowering foods | Other | Dietary Supplement: Dietary portfolio of cholesterol-lowering foodsDietary advice to consume a dietary portfolio of cholesterol-lowering foods |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary portfolio of cholesterol-lowering foodsA 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) | Dietary supplement | A portfolio of cholesterol-lowering foods |
Primary outcome
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
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
C-reactive protein
Time frame: 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
7 secondary outcomes
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
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
Lp(a)
Time frame: 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
Compliance to dietary portfolio components
Time frame: 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
Oxidative stress markers
Time frame: week 0 and every 6 months to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Background: PubMed 12489074Jenkins 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.
- Background: PubMed 12876093Jenkins 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.
- Background: PubMed 14624410Jenkins 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.
- Results publication: PubMed 16522904Jenkins 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.
- Derived from this study: PubMed 18078870Jenkins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David JA Jenkins, MD, PhD, DSc principal investigator
Department of Nutritional Sciences, Faculty of Medicine, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary portfolio of cholesterol-lowering foods in people with Hyperlipidemia and Cardiovascular Diseases, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00438893, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.