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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
152
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.
27g placebo chocolate bar to be consumed for 365 days.
University of East Anglia (UK); School of Medicine, Health Policy and Practice
Norwich, Norfolk, United Kingdom
Change in cardiovascular disease risk indictaors - including carotid intima-media thickness (CIMT), total plaque volume (TPV) (at the carotid bifurcation), pulse wave velocity (PWV) and biomarkers of risk in blood samples .
Time frame: 6 months - 1 year
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