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Cocoa Flavanols and Painfree Walking Distance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01064583
First Posted: February 8, 2010
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Long-term Effect of Dietary Intervention With Flavanol-containing Cocoa on Vascular Function of Diabetic Patients

Further study details as provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • painfree walking distance [ Time Frame: 60 days ]

Secondary Outcome Measures:
  • endothelial function [ Time Frame: 60 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: February 5, 2010
First Posted: February 8, 2010
Last Update Posted: November 13, 2013
Last Verified: November 2013

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