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Cocoa Flavanols and Painfree Walking Distance

H

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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