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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

About this trial

This is an interventional prevention trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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Cocoa Flavanols in Renal Disease

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