Cocoa Flavanols in Renal Disease
- Conditions
- End Stage Renal DiseaseEndothelial Dysfunction
- Interventions
- Other: Cocoa
- Registration Number
- NCT01412320
- Lead Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Brief Summary
Purpose of the study is to characterize the potential acute and long-term improvement of dietary flavanols on vascular function in patients with end-stage renal disease (ESRD).
Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day long-term, double blind, placebo-controlled parallel study the chronic effects of dietary flavanols on vascular function in 52 patients with ESRD will be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- end stage renal disease
- >18 years
- chronic intermittent hemodialysis
- acute Infection
- acute renal failure
- heart failure (NYHA IV)
- pregnancy
- anuria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Flavanol rich cocoa Cocoa - Flavanol poor Cocoa -
- Primary Outcome Measures
Name Time Method The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion. 30 days To study the effect of flavanols on flow mediated dilation of the brachial artery after 5 minutes of forearm ischemia and reperfusion in patients with ESRD
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Heinrich-Heine-University
🇩🇪Duesseldorf, NRW, Germany