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Cocoa Flavanols in Renal Disease

This study is currently recruiting participants.
Verified October 2012 by Heinrich-Heine University, Duesseldorf
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01412320
First received: August 5, 2011
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
End Stage Renal Disease
Endothelial Dysfunction
 Other: Cocoa
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Dietary Flavanols on Cardiovascular Dysfunction in End-stage Renal Disease

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 62
Study Start Date: August 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flavanol rich cocoa Other: Cocoa
dissolved in water twice daily
Experimental: Flavanol poor Other: Cocoa
dissolved in water twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • acute Infection
  • acute renal failure
  • heart failure (NYHA IV)
  • pregnancy
  • anuria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412320

Contacts
Contact: Christos Rammos, MD 00492118118800 Christos.Rammos@med.uni-duesseldorf.de

Locations
Germany
Heinrich-Heine-University Recruiting
Duesseldorf, NRW, Germany, 40225
Contact: Christos Rammos, MD     +49 211 8118800     Christos.Rammos@med.uni-duesseldorf.de    
Principal Investigator: Tienush Rassaf, MD, PhD            
Sub-Investigator: Christos Rammos, MD            
Principal Investigator: Malte Kelm, MD, PHD            
Sponsors and Collaborators
Klinik für Kardiologie
  More Information

Publications:

Responsible Party: Klinik für Kardiologie, Christos Rammos, MD Clinic for Cardiology, Pneumology and Angiology, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01412320     History of Changes
Other Study ID Numbers: ESRD_2010
Study First Received: August 5, 2011
Last Updated: October 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013