Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 7:04 AM
Study NCT ID:
NCT01530893
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2012-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flavonoids, Blood Pressure and Blood Vessel Function
Sponsor:
University of East Anglia
Organization:
Study Overview
Official Title:
Are the Cardiovascular Responses of Individuals at Mild to Moderate Cardiovascular Risk Influenced by Dietary Flavonoid Sub-class and Dietary Form?
Status:
COMPLETED
Status Verified Date:
2014-02
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:
FASTCHECK
Brief Summary:
The primary aim of this placebo-controlled study is to determine whether flavonoids beneficially affect markers of cardiovascular disease risk in healthy subjects at elevated cardiovascular risk.
The underlying mechanisms of action of flavonoids will be assessed on blood biomarkers and we will assess the effects of the food matrix, and aspects of isoflavone metabolism.
The underlying mechanisms of action of flavonoids will be assessed on blood biomarkers and we will assess the effects of the food matrix, and aspects of isoflavone metabolism.
Detailed Description:
The study population will be healthy males (aged 50-75 years) at elevated risk of cardiovascular (CV) disease.
A target of 60 participants will be required to complete the study and a total of 70 subjects will be targeted (n=70 subjects \* \~85% anticipated completion rate = 60 subjects to complete the study).
This placebo-controlled study will test the relative efficacy of 4 different flavonoid sub-classes ((i) flavan-3-ol, (ii) anthocyanin, (iii) flavanone and (iv) isoflavone).
Accordingly, subjects will be randomised to one of the four flavonoid study groups ((i) to (iv) outlined above), and then will consume each of the following treatments in random order:
1. dietary flavonoid + placebo supplement
2. placebo food + commercially available/produced flavonoid supplement
3. placebo food + placebo supplement
Additionally, an isoflavone metabolite will be fed to establish potential vascular effects.
Each sub-class will be assessed separately and a 1 week wash-out period between treatments will be observed.
At each assessment visit, vascular function will be assessed pre- and post-intervention, with subsequent assessments made to coincide with anticipated peak plasma concentrations.
Dietary intake will be monitored during the study and participants will be required to adhere to a range of dietary and lifestyle restrictions within 3 days of each assessment to reduce potential confounding of the data assessment of interest.
A standard battery of vascular function tests will be performed on all intervention groups, with each assessment visit performed in an identical manner.
A target of 60 participants will be required to complete the study and a total of 70 subjects will be targeted (n=70 subjects \* \~85% anticipated completion rate = 60 subjects to complete the study).
This placebo-controlled study will test the relative efficacy of 4 different flavonoid sub-classes ((i) flavan-3-ol, (ii) anthocyanin, (iii) flavanone and (iv) isoflavone).
Accordingly, subjects will be randomised to one of the four flavonoid study groups ((i) to (iv) outlined above), and then will consume each of the following treatments in random order:
1. dietary flavonoid + placebo supplement
2. placebo food + commercially available/produced flavonoid supplement
3. placebo food + placebo supplement
Additionally, an isoflavone metabolite will be fed to establish potential vascular effects.
Each sub-class will be assessed separately and a 1 week wash-out period between treatments will be observed.
At each assessment visit, vascular function will be assessed pre- and post-intervention, with subsequent assessments made to coincide with anticipated peak plasma concentrations.
Dietary intake will be monitored during the study and participants will be required to adhere to a range of dietary and lifestyle restrictions within 3 days of each assessment to reduce potential confounding of the data assessment of interest.
A standard battery of vascular function tests will be performed on all intervention groups, with each assessment visit performed in an identical manner.
Study Oversight
Has Oversight DMC:
False
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?: