Cocoa Flavanols and Painfree Walking Distance

Phase 1

Completed

• Conditions: Peripheral Artery Disease; Diabetes Mellitus

• Registration Number: NCT01064583
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
painfree walking distance	60 days

Secondary Outcome Measures

Name	Time	Method
endothelial function	60 days

Trial Locations

Locations (1)

Heinrich Heine University; 🇩🇪 Düsseldorf, NRW, Germany