Cocoa Flavanols in Renal Disease

Phase 1

Completed

• Conditions: End Stage Renal Disease; Endothelial Dysfunction

• 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

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• end stage renal disease
• >18 years
• chronic intermittent hemodialysis

Exclusion Criteria

• acute Infection
• acute renal failure
• heart failure (NYHA IV)
• pregnancy
• anuria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (1)

Heinrich-Heine-University; 🇩🇪 Duesseldorf, NRW, Germany