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Cocoa Flavanols in Renal Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412320
First Posted: August 9, 2011
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
  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: Triple (Participant, 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:


Further study details as provided by Klinik für Kardiologie, Pneumologie und Angiologie, 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 ]
    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


Enrollment: 22
Study Start Date: August 2011
Study Completion Date: December 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412320


Locations
Germany
Heinrich-Heine-University
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Klinik für Kardiologie, Pneumologie und Angiologie
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, 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
First Submitted: August 5, 2011
First Posted: August 9, 2011
Last Update Posted: November 13, 2013
Last Verified: November 2013

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