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Protein-energy Oral Supplementation Enriched With Omega-3 Fatty Acids in Cardiac Cachexia

NCT00748332 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-08-22

No results posted yet for this study

Summary

Cardiac cachexia, the main feature of undernutrition in chronic heart failure, usually defined as a weight loss over 6% over 6 months, is a proven factor of morbidity and mortality in this disease. Its pathophysiology is complex, but proinflammatory cytokines seem to play a major role. Omega-3 poly-unsaturated fatty acids, present in fish oil, have proven beneficial in patients with coronary heart disease, due in part to their effects on membranes but also due to their anti-inflammatory effects, with inhibition of TNF-α and interleukins 1 and 6.

The aim of this phase III randomized controlled double-blinded study is to assess the effects of 8 weeks of a omega-3-enriched protein-energy supplement versus an iso-energetic iso-nitrogenous supplement free of omega-3 fatty acids in cardiac cachexia. Thirty patients will be included in each group. The main judgment criterion will be maximum aerobic capacity (VO2 max), which best reflects aerobic capacity that correlates with muscle mass. Anthropometric, biological (nutritional, inflammatory and involved in food intake control), cardiac (functional) and quality of life will also be studied. All analyses will be performed in intention to treat.

The investigators expect a significantly higher improvement of VO2 max in the omega-3 group.

This study could lead to therapeutic advances in a frequent and severe disease.

Conditions

  • Cardiac Cachexia

Interventions

DIETARY_SUPPLEMENT

Fortimel Extra®

2 bottles (600 kcal, 40 g proteins) per day

DIETARY_SUPPLEMENT

Fortimel Care®

Fortimel Care® : 2 bottles (660 kcal, 36 g proteins, 2.38 g EPA) per day

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Stéphane Schneider, PU-PH · Department of Gastroentrology of Nice University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-06-30
Completion
2012-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00748332 on ClinicalTrials.gov