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

Fresenius Kabi

Status: Completed

Conditions: Chronic Heart Failure; Chronic Obstructive Pulmonary Disease; Cachexia

Treatments: Dietary Supplement: oral nutrition supplement, food for special medical purposes

Study type: Interventional

Funder types: Industry

Identifiers

NCT00852020

PCSU-002-CFS

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

oral nutritional supplement containing n-3-fatty acids, amino acids and antioxidants

Treatment:

Dietary Supplement: oral nutrition supplement, food for special medical purposes

2

Placebo Comparator group

Description:

oral nutritional supplement (isocaloric, isonitrogenous)

Treatment:

Dietary Supplement: oral nutrition supplement, food for special medical purposes