Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients

Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in CHF and COPD Patients. A Randomised, Double-blind and Controlled Pilot Study.

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).

Inclusion Criteria:

• diagnosis of CHF or COPD
• current body weight less than 6 months ago
• BMI >=20 and <=30 kg/m2
• CHF: LVEF >=45% measured within the past 6 months
• symptom status equivalent to NYHA class II to IV
• biochemical abnormalities for total cholesterol, serum uric acid, abnormal high CRP
• on standard therapy of CHF including ACE inhibitors and beta blockers
• COPD: symptom status equivalent to GOLD standard class II to IV
• FEV1 < 80%
• FEV1/FEV < 70%

Exclusion Criteria:

• significant oedema in the time of screening and randomisation
• concomitant inflammatory diseases
• active infections including HIV and AIDS
• liver failure
• chronic renal failure (sCr>1.5mg/dL) or cardiac pacemaker
• acute or chronic infections
• insulin treated diabetes mellitus
• patient with established diagnosis of cachexia
• life expectancy of less than 6 months in the opinion of the investigator
• medications that impair sex hormone synthesis, secretion or function
• patients with psychiatric diseases
• body weight loss > 5% during the last 6 months or > 10% during the last 10 months
• suspected allergy to any component of the investigational product(s)
• fish oil supplementation within 3 months prior to the study entry
• taking vitamin supplements in doses greater than the Recommended Daily Allowances