Cocoa Flavanols in Renal Disease

• Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie (Other)
• Overall Status: Completed
• CT.gov ID: NCT01412320
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease; Endothelial Dysfunction	Other: Cocoa; Other: Cocoa	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• 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
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Flavanol rich cocoa	Other: Cocoa; dissolved in water twice daily
Experimental: Flavanol poor	Other: Cocoa; dissolved in water twice daily

Outcome Measures

Primary Outcome Measures

1. The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion. [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Heinrich-Heine-University	Duesseldorf	NRW	Germany	40225

Sponsors and Collaborators

• Klinik für Kardiologie, Pneumologie und Angiologie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• 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
• Other Study ID Numbers: ESRD_2010
• First Posted: Aug 9, 2011
• Last Update Posted: Nov 13, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Kidney Diseases; Kidney Failure, Chronic

Study Results

No Results Posted as of Nov 13, 2013