NCT00852020

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

February 13, 2009

Last Update Submit

January 30, 2017

Conditions

CachexiaChronic Obstructive Pulmonary DiseaseChronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • compliance to nutrition therapy

    baseline, months 1, 2, 3, 4

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

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

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

2

PLACEBO COMPARATOR

oral nutritional supplement (isocaloric, isonitrogenous)

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

Interventions

oral nutrition supplement, food for special medical purposesDIETARY_SUPPLEMENT

2 servings of 200-300 ml per day, treatment period: 16 weeks

12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum

Berlin, D-13353, Germany

Location

Praxis für Pneumologie, Schwedt/Oder

Schwedt, D-16303, Germany

Location

Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED

Piekary Śląskie, PL-41-940, Poland

Location

Specjalista Chorób Wewnętrznych Kardiolog

Ruda Śląska, PL-41-709, Poland

Location

MeSH Terms

Conditions

CachexiaPulmonary Disease, Chronic Obstructive

Interventions

Food

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinnessLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Stefan Anker, Prof. MD PHD

    Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 26, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

DE(2)PL(2)