HyperlipidemiaPhase 2NCT00345722
The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio
A Phase 2 study testing strawberry dietary intervention 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 determine whether addition of strawberries to a dietary portfolio of cholesterol-lowering foods will improve compliance and so increase the effectiveness of the dietary portfolio in lowering cholesterol and improving 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?
- strawberry dietary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2006to Feb 2007
- Phase
- Phase 2
- 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 dietary 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 mmmol/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 determine whether addition of strawberries to a dietary portfolio of cholesterol-lowering foods will improve compliance and so increase the effectiveness of the dietary portfolio in lowering cholesterol and improving cardiovascular risk factors.
Read the detailed description
We have shown in 1-month metabolic studies that the dietary portfolio can lower cholesterol to the same extent as first generation statins (cholesterol-lowering drugs). In the on-going long-term 'real world' study using this dietary portfolio, only one-third of participants were able to achieve similar cholesterol reductions at the end of 1 year. Varying compliance has been identified as the main issue why the other two-thirds could not achieve a similar level of reduction. We believe the addition of strawberries to this diet, by virtue of their beneficial components (fibre and antioxidants)and by replacement of less desirable foods (fatty deserts), may further improve the CHD risk profile of a very effective cholesterol reduction strategy.
Method:
454 g of strawberries per 2000 kcal per day will be provided for a one-month period to approximately 40-50 subjects on a long-term dietary portfolio study, all of whom have been on the diet for at least 6 months to 1 year. The active dietary components consist of viscous vibers (including oat bran), soy products (including soy milk), almonds and plant sterols (sterol enriched margarine). Strawberry recipes will be used to enhance compliance of these components. Subjects will undergo the study in a randomized crossover design where the control will be the dietary portfolio with additional 65 g oatbran bread (without psyllium) replacing the strawberries.
Bloods will be taken at weeks 0, 2 and 4 of each treatment period; and at one month prior to and after the 8-week study while on the long-term dietary portfolio.
- Being tested
- strawberry dietary intervention
- Keywords
- Strawberry, Almond, Soy protein, viscous dietary fibre, plant sterols, portfolio diet, blood lipids, compliance, 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.
strawberry dietary interventionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol measured at weeks 0, 2, and 4 of each phase
LDL cholesterol measured at weeks 0, 2, and 4 of each phase
C-reactive protein measured at weeks 0, 2 and 4 of each phase
Blood pressure measured at weeks 0, 2 and 4 of each phase
Secondary outcomes (7)
Apolipoprotein A1 and B measured at weeks 0, 2, and 4 of each phase
Lp(a) measured at weeks 0, 2, and 4 of each phase
Oxidative stress measured at weeks 0, 2, and 4 of each phase
Strawberry intake measured at weeks 0, 2, and 4 of each phase
Compliance to portfolio diet components measured at weeks 0, 2 and 4 of each phase
24 hour urinary potassium measured at weeks 0 and 4 of each phase
24 hour urinary calcium measured at weeks 0 and 4 of each phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startJun 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- California Strawberry Commission, Almond Board of California, Unilever R&D, Natural Sciences and Engineering Research Council, Canada
- Investigators
- David JA Jenkins, MD PhD DSc, Principal investigator, Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, 150 College St. Rm 340, Toronto, ON M5S 3E2, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345722
- Sponsor's protocol ID
- REB 03-043C
- Other IDs
- HC-CT#100934
- Status last verified
- May 2007
- First submitted
- 26 Jun 2006
- Last updated
- 8 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2007. 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
- NCT00345722
- Acronym / sponsor ID
- REB 03-043C
- Keywords
- Strawberry, Almond, Soy protein, viscous dietary fibre, plant sterols, portfolio diet, blood lipids, compliance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- California Strawberry Commission, Almond Board of California, Unilever R&D, Natural Sciences and Engineering Research Council, Canada
- Study start
- Jun 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 28 Jun 2006 (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 determine whether addition of strawberries to a dietary portfolio of cholesterol-lowering foods will improve compliance and so increase the effectiveness of the dietary portfolio in lowering cholesterol and improving cardiovascular risk factors.
Detailed description
We have shown in 1-month metabolic studies that the dietary portfolio can lower cholesterol to the same extent as first generation statins (cholesterol-lowering drugs). In the on-going long-term 'real world' study using this dietary portfolio, only one-third of participants were able to achieve similar cholesterol reductions at the end of 1 year. Varying compliance has been identified as the main issue why the other two-thirds could not achieve a similar level of reduction. We believe the addition of strawberries to this diet, by virtue of their beneficial components (fibre and antioxidants)and by replacement of less desirable foods (fatty deserts), may further improve the CHD risk profile of a very effective cholesterol reduction strategy.
Method:
454 g of strawberries per 2000 kcal per day will be provided for a one-month period to approximately 40-50 subjects on a long-term dietary portfolio study, all of whom have been on the diet for at least 6 months to 1 year. The active dietary components consist of viscous vibers (including oat bran), soy products (including soy milk), almonds and plant sterols (sterol enriched margarine). Strawberry recipes will be used to enhance compliance of these components. Subjects will undergo the study in a randomized crossover design where the control will be the dietary portfolio with additional 65 g oatbran bread (without psyllium) replacing the strawberries.
Bloods will be taken at weeks 0, 2 and 4 of each treatment period; and at one month prior to and after the 8-week study while on the long-term dietary portfolio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
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 dietary 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 |
|---|---|---|
| strawberry dietary intervention | Procedure or surgery | – |
Primary outcome
Total cholesterol measured at weeks 0, 2, and 4 of each phase
LDL cholesterol measured at weeks 0, 2, and 4 of each phase
C-reactive protein measured at weeks 0, 2 and 4 of each phase
Blood pressure measured at weeks 0, 2 and 4 of each phase
7 secondary outcomes
Apolipoprotein A1 and B measured at weeks 0, 2, and 4 of each phase
Lp(a) measured at weeks 0, 2, and 4 of each phase
Oxidative stress measured at weeks 0, 2, and 4 of each phase
Strawberry intake measured at weeks 0, 2, and 4 of each phase
Compliance to portfolio diet components measured at weeks 0, 2 and 4 of each phase
24 hour urinary potassium measured at weeks 0 and 4 of each phase
24 hour urinary calcium measured at weeks 0 and 4 of each phase
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 8 May 2007.
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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, 150 College St. Rm 340, Toronto, ON M5S 3E2, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing strawberry dietary intervention 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 8 May 2007. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 measured at weeks 0, 2, and 4 of each phase. 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?
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 8 May 2007.