NCT00771797

Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment

Clinical Study to Assess the Clinical Efficacy of Flavanol-rich Cocoa on Vascular Function in Diabetic Patients With PAOD

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the clinical efficacy and to simultaneously explore the underlying molecular mechanisms of the beneficial effects of flavanol-rich cocoa on vascular function diabetic patients with peripheral artery occlusive diseases (PAOD) of the lower extremities will be investigated.

Detailed description

50 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 200 m will be enrolled. In a randomized controlled parallel group study the before established novel 5-level approach of vascular diagnostics will be realised. In order to test the hypothesis, whether cocoa rich in flavanols improves vascular function of diabetic PAOD subjects will regularly intake flavanol rich cocoa (group 1: 975 mg/d, n=50 versus group 2: 90 mg/d, n=50) over a period of two months. Clinical endpoints are the Ankle-Brachial-Index, measured by Doppler ultrasound and the pain-free walking distance determined by a treadmill ergometer. All parameters of vascular diagnostic (see 5-level approach above) will be determined before and two month after cocoa ingestion.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	high dose flavanoids	flavanoid rich cocoa 2 times daily over 60 days
DIETARY_SUPPLEMENT	low dose flavanoids	treatment with flavanoid-low cocoa two times daily over 60 days

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-10-13
• Last updated: 2015-09-23

Locations

1 site across 1 country: Germany