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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flavanol rich cocoa drink (596mg) | Experimental | dissolved in water, twice daily intervention |
|
| flavanol poor cocoa drink ( 13mg) | Experimental | dissolved in water, twice daily intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cocoa | Other | dissolved in water twice-daily intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| painfree walking distance | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| endothelial function | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Heiss, MD | Heinrich Heine University | Principal Investigator |
| Malte Kelm, MD | Heinrich Heine University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heinrich Heine University | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069956 | Chocolate |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |