NCT01530893

Flavonoids, Blood Pressure and Blood Vessel Function

Are the Cardiovascular Responses of Individuals at Mild to Moderate Cardiovascular Risk Influenced by Dietary Flavonoid Sub-class and Dietary Form?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of East Anglia · Academic / Other
• Sex: Male
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Cardiovascular Disease Risk Reduction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Flavanone - supplement	acute single optimal dose
OTHER	Flavanone - food	acute single dose
OTHER	Flavanone - placebo	acute single dose (flavanone free)
DIETARY_SUPPLEMENT	Isoflavone - supplement	acute single optimal dose
OTHER	Isoflavone - food	acute single optimal dose
OTHER	Isoflavone - placebo	acute single dose (isoflavone free)
DIETARY_SUPPLEMENT	Isoflavone - metabolite supplement	acute single optimal dose of commercial product
DIETARY_SUPPLEMENT	Flavan-3-ol - supplement	acute single optimal dose
OTHER	Flavan-3-ol - food	acute single optimal dose
OTHER	Flavan-3-ol - placebo	acute single dose (flavan-3-ol free)
DIETARY_SUPPLEMENT	Anthocyanin - supplement	acute single optimal dose
OTHER	Anthocyanin - food	acute single optimal dose
OTHER	Anthocyanin - placebo	acute single dose (anthocyanin free)

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-02-10
• Last updated: 2014-02-28

Locations

1 site across 1 country: United Kingdom