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

Primary Purpose

Cachexia, Chronic Obstructive Pulmonary Disease, Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
oral nutrition supplement, food for special medical purposes
Sponsored by
Fresenius Kabi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cachexia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum
  • Praxis für Pneumologie, Schwedt/Oder
  • Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED
  • Specjalista Chorób Wewnętrznych Kardiolog

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

oral nutritional supplement (isocaloric, isonitrogenous)

Outcomes

Primary Outcome Measures

compliance to nutrition therapy

Secondary Outcome Measures

anorexia questionnaire
Gastrointestinal syndrome score (GIS)
body cell mass
weight change
hand grip strength
patient global assessment (PGA)

Full Information

First Posted
February 13, 2009
Last Updated
January 30, 2017
Sponsor
Fresenius Kabi
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1. Study Identification

Unique Protocol Identification Number
NCT00852020
Brief Title
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Kabi

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, Chronic Obstructive Pulmonary Disease, Chronic Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
oral nutritional supplement containing n-3-fatty acids, amino acids and antioxidants
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
oral nutritional supplement (isocaloric, isonitrogenous)
Intervention Type
Dietary Supplement
Intervention Name(s)
oral nutrition supplement, food for special medical purposes
Intervention Description
2 servings of 200-300 ml per day, treatment period: 16 weeks
Primary Outcome Measure Information:
Title
compliance to nutrition therapy
Time Frame
baseline, months 1, 2, 3, 4
Secondary Outcome Measure Information:
Title
anorexia questionnaire
Time Frame
baseline, months 1, 2, 3, 4
Title
Gastrointestinal syndrome score (GIS)
Time Frame
baseline, months 1, 2, 3, 4
Title
body cell mass
Time Frame
baseline, months 1, 2, 3, 4
Title
weight change
Time Frame
baseline, months 1, 2, 3, 4
Title
hand grip strength
Time Frame
baseline, months 1, 2, 3, 4
Title
patient global assessment (PGA)
Time Frame
baseline, months 2, 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Anker, Prof. MD PHD
Organizational Affiliation
Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Praxis für Pneumologie, Schwedt/Oder
City
Schwedt/Oder
ZIP/Postal Code
D-16303
Country
Germany
Facility Name
Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED
City
Piekary Śląskie
ZIP/Postal Code
PL-41-940
Country
Poland
Facility Name
Specjalista Chorób Wewnętrznych Kardiolog
City
Ruda Śląska
ZIP/Postal Code
PL-41-709
Country
Poland

12. IPD Sharing Statement

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

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