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To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | oral nutritional supplement containing n-3-fatty acids, amino acids and antioxidants |
|
| 2 | Placebo Comparator | oral nutritional supplement (isocaloric, isonitrogenous) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral nutrition supplement, food for special medical purposes | Dietary Supplement | 2 servings of 200-300 ml per day, treatment period: 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| compliance to nutrition therapy | baseline, months 1, 2, 3, 4 |
| Measure | Description | Time Frame |
|---|---|---|
| anorexia questionnaire | baseline, months 1, 2, 3, 4 | |
| Gastrointestinal syndrome score (GIS) | baseline, months 1, 2, 3, 4 | |
| body cell mass |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Anker, Prof. MD PHD | Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum | Berlin | D-13353 | Germany | |||
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| baseline, months 1, 2, 3, 4 |
| weight change | baseline, months 1, 2, 3, 4 |
| hand grip strength | baseline, months 1, 2, 3, 4 |
| patient global assessment (PGA) | baseline, months 2, 4 |
| Praxis für Pneumologie, Schwedt/Oder |
| Schwedt |
| D-16303 |
| Germany |
| Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED | Piekary Śląskie | PL-41-940 | Poland |
| Specjalista Chorób Wewnętrznych Kardiolog | Ruda Śląska | PL-41-709 | Poland |
| ID | Term |
|---|---|
| D002100 | Cachexia |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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