Cocoa Flavanols and Painfree Walking Distance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01064583
First received: February 5, 2010
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

To characterize potential vascular long-term effects of flavanols in patients with peripheral artery occlusive disease (PAOD), a placebo-controlled double-blinded randomized control study will be performed in 62 patients randomized in two groups. Patients will twice daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of 60 days months.


Condition Intervention Phase
Peripheral Artery Disease
Diabetes Mellitus
Other: cocoa
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Long-term Effect of Dietary Intervention With Flavanol-containing Cocoa on Vascular Function of Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • painfree walking distance [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • endothelial function [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: flavanol rich cocoa drink (596mg)
dissolved in water, twice daily intervention
Other: cocoa
dissolved in water twice-daily intervention
Experimental: flavanol poor cocoa drink ( 13mg)
dissolved in water, twice daily intervention
Other: cocoa
dissolved in water twice-daily intervention

Detailed Description:

62 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 250m will be enrolled.

Patients will twice daily receive either a flavanol-poor cocoa drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 60 days.

The general condition, the pain free walking distance and the vascular function measured by Doppler Ultrasound will be determined before and two month after cocoa ingestion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • peripheral artery disease (Fontaine IIb)
  • diabetes mellitus
  • > 18 years

Exclusion Criteria:

  • acute and terminal renal failure
  • acute infection
  • heart failure (NYHA III-IV)
  • arrhythmias
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01064583

Locations
Germany
Heinrich Heine University
Düsseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Christian Heiss, MD Heinrich Heine University
Study Chair: Malte Kelm, MD Heinrich Heine University
  More Information

Additional Information:
No publications provided

Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01064583     History of Changes
Other Study ID Numbers: Flavanols-PAD
Study First Received: February 5, 2010
Last Updated: November 12, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Diabetes Mellitus
Peripheral Arterial Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on October 02, 2014