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Completed

NCT Number: NCT01064583

Cocoa Flavanols and Painfree Walking Distance

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Heinrich Heine University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cocoa

Other

dissolved in water twice-daily intervention

Primary outcomes

  1. painfree walking distance

    Time frame: 60 days

Secondary outcomes

  1. endothelial function

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

Long-term Effect of Dietary Intervention With Flavanol-containing Cocoa on Vascular Function of Diabetic Patients

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2010
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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