Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345722
Status:
COMPLETED
Last Update Posted:
2007-05-08
First Post:
2006-06-26
Brief Title:
The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio
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:
2007-05
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 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 antioxidantsand 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
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 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 |