Cocoa Flavanols in Renal Disease

End Stage Renal Disease Clinical Trial

Official title:

The Impact of Dietary Flavanols on Cardiovascular Dysfunction in End-stage Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412320
• Other study ID #: ESRD_2010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 5, 2011
• Last updated: November 12, 2013
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• end stage renal disease

• >18 years

• chronic intermittent hemodialysis

Exclusion Criteria:

• acute Infection

• acute renal failure

• heart failure (NYHA IV)

• pregnancy

• anuria

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• End Stage Renal Disease
• Endothelial Dysfunction
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Other:
• Cocoa
dissolved in water twice daily
• Cocoa
dissolved in water twice daily

Locations

Country	Name	City	State
Germany	Heinrich-Heine-University	Duesseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days	No