Cocoa Flavanols in Renal Disease

Klinik für Kardiologie, Pneumologie und Angiologie

Status and phase: Completed; Phase 2; Phase 1

Conditions: Endothelial Dysfunction; End Stage Renal Disease

Treatments: Other: Cocoa

Study type: Interventional

Funder types: Other

Identifiers

NCT01412320

ESRD_2010

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups

Flavanol rich cocoa

Experimental group

Treatment:

Other: Cocoa

Other: Cocoa

Flavanol poor

Experimental group

Treatment:

Other: Cocoa

Other: Cocoa