Cocoa Flavanols in Renal Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01412320
First received: August 5, 2011
Last updated: November 12, 2013
Last verified: November 2013

August 5, 2011
November 12, 2013
August 2011
December 2012   (final data collection date for primary outcome measure)
The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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
An improvement of endothelial function as measured by flow-mediated dilation (FMD) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01412320 on ClinicalTrials.gov Archive Site
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Cocoa Flavanols in Renal Disease
The Impact of Dietary Flavanols on Cardiovascular Dysfunction in End-stage Renal Disease

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • End Stage Renal Disease
  • Endothelial Dysfunction
Other: Cocoa
dissolved in water twice daily
  • Experimental: Flavanol rich cocoa
    Intervention: Other: Cocoa
  • Experimental: Flavanol poor
    Intervention: Other: Cocoa
Balzer J, Rassaf T, Heiss C, Kleinbongard P, Lauer T, Merx M, Heussen N, Gross HB, Keen CL, Schroeter H, Kelm M. Sustained benefits in vascular function through flavanol-containing cocoa in medicated diabetic patients a double-masked, randomized, controlled trial. J Am Coll Cardiol. 2008 Jun 3;51(22):2141-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • acute Infection
  • acute renal failure
  • heart failure (NYHA IV)
  • pregnancy
  • anuria
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01412320
ESRD_2010
Yes
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
Klinik für Kardiologie, Pneumologie und Angiologie
Not Provided
Not Provided
Heinrich-Heine University, Duesseldorf
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP