Cocoa Flavanols in Renal Disease
NCT01412320 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2013-11-13
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.
Conditions
- End Stage Renal Disease
- Endothelial Dysfunction
Interventions
- OTHER
-
Cocoa
dissolved in water twice daily
- OTHER
-
Cocoa
dissolved in water twice daily
Sponsors & Collaborators
-
Klinik für Kardiologie, Pneumologie und Angiologie
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- Germany
Study Locations
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