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Cocoa Flavanols and Painfree Walking Distance

Primary Purpose

Peripheral Artery Disease, Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

cocoa

About this trial

This is an interventional prevention trial for Peripheral Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Heinrich Heine University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

flavanol rich cocoa drink (596mg)

flavanol poor cocoa drink ( 13mg)

Arm Description

dissolved in water, twice daily intervention

Outcomes

Primary Outcome Measures

painfree walking distance

Secondary Outcome Measures

endothelial function

Full Information

NCT ID

NCT01064583

First Posted

February 5, 2010

Last Updated

November 12, 2013

Sponsor

Heinrich-Heine University, Duesseldorf

1. Study Identification

Unique Protocol Identification Number

NCT01064583

Brief Title

Cocoa Flavanols and Painfree Walking Distance

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Heinrich-Heine University, Duesseldorf

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Artery Disease, Diabetes Mellitus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

flavanol rich cocoa drink (596mg)

Arm Type

Experimental

Arm Description

dissolved in water, twice daily intervention

Arm Title

flavanol poor cocoa drink ( 13mg)

Arm Type

Experimental

Arm Description

dissolved in water, twice daily intervention

Intervention Type

Other

Intervention Name(s)

cocoa

Intervention Description

dissolved in water twice-daily intervention

Primary Outcome Measure Information:

Title

painfree walking distance

Time Frame

60 days

Secondary Outcome Measure Information:

Title

endothelial function

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Heiss, MD

Organizational Affiliation

Heinrich Heine University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Malte Kelm, MD

Organizational Affiliation

Heinrich Heine University

Official's Role

Study Chair

Facility Information:

Facility Name

Heinrich Heine University

City

Düsseldorf

State/Province

NRW

ZIP/Postal Code

40225

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.uniklinik-duesseldorf.de/kardiologie

Description

Related Info

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Cocoa Flavanols and Painfree Walking Distance

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