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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Heart Failure; Cachexia
• Intervention / Treatment: Dietary supplement: oral nutrition supplement, food for special medical purposes

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, D-13353
    • Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum
  • Schwedt/Oder, Germany, D-16303
    • Praxis für Pneumologie, Schwedt/Oder
• Poland
  • Piekary Śląskie, Poland, PL-41-940
    • Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED
  • Ruda Śląska, Poland, PL-41-709
    • Specjalista Chorób Wewnętrznych Kardiolog

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; oral nutritional supplement containing n-3-fatty acids, amino acids and antioxidants	Dietary supplement: oral nutrition supplement, food for special medical purposes; 2 servings of 200-300 ml per day, treatment period: 16 weeks
Placebo Comparator: 2; oral nutritional supplement (isocaloric, isonitrogenous)	Dietary supplement: oral nutrition supplement, food for special medical purposes; 2 servings of 200-300 ml per day, treatment period: 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
compliance to nutrition therapy	baseline, months 1, 2, 3, 4

Secondary Outcome Measures

Outcome Measure	Time Frame
anorexia questionnaire	baseline, months 1, 2, 3, 4
Gastrointestinal syndrome score (GIS)	baseline, months 1, 2, 3, 4
body cell mass	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

Collaborators and Investigators

• Sponsor: Fresenius Kabi
• Investigators: Principal Investigator: Stefan Anker, Prof. MD PHD, Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: February 13, 2009
• First Submitted That Met QC Criteria: February 25, 2009
• First Posted (Estimate): February 26, 2009

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Heart Failure; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cachexia
• Other Study ID Numbers: PCSU-002-CFS