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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00852020
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Cachexia Chronic Obstructive Pulmonary Disease Chronic Heart Failure Dietary Supplement: oral nutrition supplement, food for special medical purposes

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in CHF and COPD Patients. A Randomised, Double-blind and Controlled Pilot Study.
Study Start Date : April 2009
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. compliance to nutrition therapy [ Time Frame: baseline, months 1, 2, 3, 4 ]

Secondary Outcome Measures :
  1. anorexia questionnaire [ Time Frame: baseline, months 1, 2, 3, 4 ]
  2. Gastrointestinal syndrome score (GIS) [ Time Frame: baseline, months 1, 2, 3, 4 ]
  3. body cell mass [ Time Frame: baseline, months 1, 2, 3, 4 ]
  4. weight change [ Time Frame: baseline, months 1, 2, 3, 4 ]
  5. hand grip strength [ Time Frame: baseline, months 1, 2, 3, 4 ]
  6. patient global assessment (PGA) [ Time Frame: baseline, months 2, 4 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852020


Locations
Germany
Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum
Berlin, Germany, D-13353
Praxis für Pneumologie, Schwedt/Oder
Schwedt/Oder, Germany, D-16303
Poland
Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED
Piekary Śląskie, Poland, PL-41-940
Specjalista Chorób Wewnętrznych Kardiolog
Ruda Śląska, Poland, PL-41-709
Sponsors and Collaborators
Fresenius Kabi
Investigators
Principal Investigator: Stefan Anker, Prof. MD PHD Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin
More Information

Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT00852020     History of Changes
Other Study ID Numbers: PCSU-002-CFS
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cachexia
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms