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
  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:


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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412320

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

Publications:
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
Study First Received: August 5, 2011
Last Updated: November 12, 2013
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 September 18, 2014