Cocoa Flavanols in Renal Disease
Primary Purpose
End Stage Renal Disease, Endothelial Dysfunction
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Cocoa
Cocoa
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease
Eligibility 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
Sites / Locations
- Heinrich-Heine-University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Flavanol rich cocoa
Flavanol poor
Arm Description
Outcomes
Primary Outcome Measures
The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01412320
First Posted
August 5, 2011
Last Updated
November 12, 2013
Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
1. Study Identification
Unique Protocol Identification Number
NCT01412320
Brief Title
Cocoa Flavanols in Renal Disease
Official Title
The Impact of Dietary Flavanols on Cardiovascular Dysfunction in End-stage Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Endothelial Dysfunction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flavanol rich cocoa
Arm Type
Experimental
Arm Title
Flavanol poor
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cocoa
Intervention Description
dissolved in water twice daily
Intervention Type
Other
Intervention Name(s)
Cocoa
Intervention Description
dissolved in water twice daily
Primary Outcome Measure Information:
Title
The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
Description
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
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Heinrich-Heine-University
City
Duesseldorf
State/Province
NRW
ZIP/Postal Code
40225
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18510961
Citation
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. doi: 10.1016/j.jacc.2008.01.059.
Results Reference
background
PubMed Identifier
26485680
Citation
Luedike P, Rammos C, Pohl J, Heisler M, Totzeck M, Kleophas W, Hetzel GR, Kelm M, Hendgen-Cotta U, Rassaf T. Filtration of Macrophage Migration Inhibitory Factor (MIF) in Patients with End Stage Renal Disease Undergoing Hemodialysis. PLoS One. 2015 Oct 20;10(10):e0140215. doi: 10.1371/journal.pone.0140215. eCollection 2015.
Results Reference
derived
Learn more about this trial
Cocoa Flavanols in Renal Disease
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