NCT01412320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

1.3 years

First QC Date

August 5, 2011

Last Update Submit

November 12, 2013

Conditions

End Stage Renal DiseaseEndothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Flavanol rich cocoa

EXPERIMENTAL
Other: Cocoa

Flavanol poor

EXPERIMENTAL
Other: Cocoa

Interventions

CocoaOTHER

dissolved in water twice daily

Flavanol rich cocoa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • end stage renal disease
  • \>18 years
  • chronic intermittent hemodialysis

You may not qualify if:

  • acute Infection
  • acute renal failure
  • heart failure (NYHA IV)
  • pregnancy
  • anuria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (3)

  • 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.

    PMID: 18510961BACKGROUND

  • 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.

    PMID: 37916745DERIVED

  • 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.

    PMID: 26485680DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Christos Rammos, MD Clinic for Cardiology, Pneumology and Angiology

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 9, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

DE(1)