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

Not Applicable

Completed

• Conditions: Cachexia; Chronic Obstructive Pulmonary Disease; Chronic Heart Failure
• Interventions: Dietary Supplement: oral nutrition supplement, food for special medical purposes

• Registration Number: NCT00852020
• Lead Sponsor: Fresenius Kabi

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-25
• Study First Posted: 2009-02-26
• Study Start: 2009-04
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	oral nutrition supplement, food for special medical purposes	oral nutritional supplement (isocaloric, isonitrogenous)
1	oral nutrition supplement, food for special medical purposes	oral nutritional supplement containing n-3-fatty acids, amino acids and antioxidants

Primary Outcome Measures

Name	Time	Method
compliance to nutrition therapy	baseline, months 1, 2, 3, 4

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal syndrome score (GIS)	baseline, months 1, 2, 3, 4
body cell mass	baseline, months 1, 2, 3, 4
hand grip strength	baseline, months 1, 2, 3, 4
patient global assessment (PGA)	baseline, months 2, 4
anorexia questionnaire	baseline, months 1, 2, 3, 4
weight change	baseline, months 1, 2, 3, 4

Trial Locations

Locations (4)

Praxis für Pneumologie, Schwedt/Oder; 🇩🇪 Schwedt/Oder, Germany

Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED; 🇵🇱 Piekary Śląskie, Poland

Specjalista Chorób Wewnętrznych Kardiolog; 🇵🇱 Ruda Śląska, Poland

Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany