Cocoa Flavanols and Painfree Walking Distance

Heinrich-Heine University, Duesseldorf

Status and phase: Completed; Phase 2; Phase 1

Conditions: Peripheral Artery Disease; Diabetes Mellitus

Treatments: Other: cocoa

Study type: Interventional

Funder types: Other

Identifiers

NCT01064583

Flavanols-PAD

Details and patient eligibility

About

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.

Full 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

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

flavanol rich cocoa drink (596mg)

Experimental group

Description:

dissolved in water, twice daily intervention

Treatment:

Other: cocoa

flavanol poor cocoa drink ( 13mg)

Experimental group

Description:

dissolved in water, twice daily intervention

Treatment:

Other: cocoa