NCT01064583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

3.1 years

First QC Date

February 5, 2010

Last Update Submit

November 12, 2013

Conditions

Peripheral Artery DiseaseDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • painfree walking distance

    60 days

Secondary Outcomes (1)

  • endothelial function

    60 days

Study Arms (2)

flavanol rich cocoa drink (596mg)

EXPERIMENTAL

dissolved in water, twice daily intervention

Other: cocoa

flavanol poor cocoa drink ( 13mg)

EXPERIMENTAL

dissolved in water, twice daily intervention

Other: cocoa

Interventions

cocoaOTHER

dissolved in water twice-daily intervention

flavanol poor cocoa drink ( 13mg)flavanol rich cocoa drink (596mg)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • peripheral artery disease (Fontaine IIb)
  • diabetes mellitus
  • \> 18 years

You may not qualify if:

  • acute and terminal renal failure
  • acute infection
  • heart failure (NYHA III-IV)
  • arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heinrich Heine University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Links

MeSH Terms

Conditions

Peripheral Arterial DiseaseDiabetes Mellitus

Interventions

Chocolate

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Christian Heiss, MD

    Heinrich Heine University

    PRINCIPAL INVESTIGATOR

  • Malte Kelm, MD

    Heinrich Heine University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Klinik für Kardiologie, Pneumologie und Angiologie

Study Record Dates

First Submitted

February 5, 2010

First Posted

February 8, 2010

Study Start

October 1, 2009

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

DE(1)