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

Study Overview
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Brief Summary
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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).

Official Title
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Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in CHF and COPD Patients. A Randomised, Double-blind and Controlled Pilot Study.

Conditions
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Cachexia, Chronic Obstructive Pulmonary Disease, Chronic Heart Failure

Intervention / Treatment
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* Dietary Supplement: oral nutrition supplement, food for special medical purposes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |