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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00852020

Enrollment

Registered

2009-02-26

Start date

2009-04-30

Completion date

2011-04-30

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cachexia, Chronic Heart Failure, Chronic Obstructive Pulmonary Disease

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).

Interventions

DIETARY_SUPPLEMENToral nutrition supplement, food for special medical purposes

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026