Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2011-08-31
2012-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Flavanol rich cocoa
Cocoa
dissolved in water twice daily
Flavanol poor
Cocoa
dissolved in water twice daily
Interventions
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Cocoa
dissolved in water twice daily
Cocoa
dissolved in water twice daily
Eligibility Criteria
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Inclusion Criteria
* \>18 years
* chronic intermittent hemodialysis
Exclusion Criteria
* acute renal failure
* heart failure (NYHA IV)
* pregnancy
* anuria
18 Years
ALL
No
Sponsors
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Klinik für Kardiologie, Pneumologie und Angiologie
OTHER
Responsible Party
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Klinik für Kardiologie, Pneumologie und Angiologie
Christos Rammos, MD Clinic for Cardiology, Pneumology and Angiology
Locations
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Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, Germany
Countries
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References
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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.
Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
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.
Other Identifiers
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ESRD_2010
Identifier Type: -
Identifier Source: org_study_id