Cocoa Flavanols and Painfree Walking Distance

November 12, 2013 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Düsseldorf, NRW, Germany, 40225
        • Heinrich Heine University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
painfree walking distance
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
endothelial function
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Christian Heiss, MD, Heinrich Heine University
  • Study Chair: Malte Kelm, MD, Heinrich Heine University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (ESTIMATE)

February 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 12, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Flavanols-PAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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