NCT00677599

The FLAVO Trial: Dietary Flavonoids and Cardiovascular Disease Risk Reduction in Postmenopausal Women With Type 2 Diabetes

Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: University of East Anglia · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this placebo controlled trial is to determine whether a year long intervention with flavonoids (found in cocoa and soy) is more effective in reducing the risk of cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy (statins). A range of markers of cardiovascular disease risk are being studied and volunteers are also providing urine and blood samples. 152 postmenopausal women, from the locality, will be recruited for this study.

Conditions

• Cardiovascular Disease
• Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Flavonoid enrichment (cocoa / soy compounds)	Flavonoid compounds from cocoa (including epicatechin) and soy to be consumed for 365days in the experimental intervention (versus placebo consumption). 27g chocolate bar the vehicle for flavonoid enrichment.
DIETARY_SUPPLEMENT	Flavonoid enrichment (cocoa / soy compounds)	27g placebo chocolate bar to be consumed for 365 days.

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-05-14
• Last updated: 2011-05-13

Locations

1 site across 1 country: United Kingdom