Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00438893
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2007-02-20
Brief Title:
Effects of a Long Term Dietary Portfolio and of Sequential Removal of Food Components From the Diet
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HC-CT100934 | None | None | None |