Cocoa Flavanols and Painfree Walking Distance
- Conditions
- Peripheral Artery DiseaseDiabetes Mellitus
- Interventions
- Other: cocoa
- Registration Number
- NCT01064583
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- Brief Summary
To characterize potential vascular long-term effects of flavanols in patients with peripheral artery occlusive disease (PAOD), a placebo-controlled double-blinded randomized control study will be performed in 62 patients randomized in two groups. Patients will twice daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of 60 days months.
- Detailed Description
62 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 250m will be enrolled.
Patients will twice daily receive either a flavanol-poor cocoa drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 60 days.
The general condition, the pain free walking distance and the vascular function measured by Doppler Ultrasound will be determined before and two month after cocoa ingestion
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- peripheral artery disease (Fontaine IIb)
- diabetes mellitus
- > 18 years
- acute and terminal renal failure
- acute infection
- heart failure (NYHA III-IV)
- arrhythmias
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description flavanol rich cocoa drink (596mg) cocoa dissolved in water, twice daily intervention flavanol poor cocoa drink ( 13mg) cocoa dissolved in water, twice daily intervention
- Primary Outcome Measures
Name Time Method painfree walking distance 60 days
- Secondary Outcome Measures
Name Time Method endothelial function 60 days
Trial Locations
- Locations (1)
Heinrich Heine University
🇩🇪Düsseldorf, NRW, Germany