End Stage Renal Disease, Endothelial Dysfunction
Conditions
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.
Interventions
OTHERCocoa
dissolved in water twice daily
Sponsors
Klinik für Kardiologie, Pneumologie und Angiologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* end stage renal disease * \>18 years * chronic intermittent hemodialysis
Exclusion criteria
* acute Infection * acute renal failure * heart failure (NYHA IV) * pregnancy * anuria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed