Clinical Trial: Protein-energy Oral Supplementation Enriched With Omega-3 Fatty Acids in Cardiac Cachexia
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Effects of a Protein-energy Oral Supplement Enriched With Omega-3 Fatty Acids Compared to a Standard Protein-energy Supplement in Cardiac Cachexia
Brief 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.
Detailed Summary:
Undernutrition is frequent in chronic heart failure (approximately 40%). Cardiac cachexia, main feature of this undernutrition, 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, thus appearing close to cancer cachexia. A number of treatments have proven to be effective in preventing undernutrition in chronic heart failure patients (ß-blockers, ACE inhibitors, diuretics and physical training). Omega-3 poly-unsaturated fatty acids, present in fish oil, haven 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. However, no study to this day has been conducted in human cardiac cachexia.
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.
We 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.
Sponsor: Centre Hospitalier Universitaire de Nice
Current Primary Outcome: VO2 max (cycle ergometry) [ Time Frame: D0 and after 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Weight, BMI, body composition (DAX and BIA), muscle function (dynamometers), biology, quality of life, cardiac function (ultra-sound end-systolic ejection fraction, walking perimeter), food intake. [ Time Frame: D0 and after 8 weeks ]
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Universitaire de Nice
Dates:
Date Received: September 4, 2008
Date Started: March 2008
Date Completion:
Last Updated: August 21, 2012
Last Verified: June 2009
