The FLAVO Trial: Dietary Flavonoids and Cardiovascular Disease Risk Reduction in Postmenopausal Women With Type 2 Diabetes
Not Applicable
Completed
- Conditions
- Cardiovascular DiseaseDiabetes
- Interventions
- Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)
- Registration Number
- NCT00677599
- Lead Sponsor
- University of East Anglia
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 152
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention A Flavonoid enrichment (cocoa / soy compounds) Experimental arm enriched with flavonoids Intervention B Flavonoid enrichment (cocoa / soy compounds) -
- Primary Outcome Measures
Name Time Method 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 . 6 months - 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of East Anglia (UK); School of Medicine, Health Policy and Practice
🇬🇧Norwich, Norfolk, United Kingdom