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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
60
2 servings of 200-300 ml per day, treatment period: 16 weeks
Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum
Berlin, Germany
Praxis für Pneumologie, Schwedt/Oder
Schwedt, Germany
Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED
Piekary Śląskie, Poland
Specjalista Chorób Wewnętrznych Kardiolog
Ruda Śląska, Poland
compliance to nutrition therapy
Time frame: baseline, months 1, 2, 3, 4
anorexia questionnaire
Time frame: baseline, months 1, 2, 3, 4
Gastrointestinal syndrome score (GIS)
Time frame: baseline, months 1, 2, 3, 4
body cell mass
Time frame: baseline, months 1, 2, 3, 4
weight change
Time frame: baseline, months 1, 2, 3, 4
hand grip strength
Time frame: baseline, months 1, 2, 3, 4
patient global assessment (PGA)
Time frame: baseline, months 2, 4
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