Cocoa Flavanols and Painfree Walking Distance

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064583
• Other study ID #: Flavanols-PAD
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 5, 2010
• Last updated: November 12, 2013
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Other:
• cocoa
dissolved in water twice-daily intervention

Locations

Country	Name	City	State
Germany	Heinrich Heine University	Düsseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	painfree walking distance		60 days	No
Secondary	endothelial function		60 days	No

External Links

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