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

Effects of a Protein-energy Oral Supplement Enriched With Omega-3 Fatty Acids Compared to a Standard Protein-energy Supplement in Cardiac Cachexia

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.

Study Overview

• Status: Terminated
• Conditions: Cardiac Cachexia
• Intervention / Treatment: Dietary supplement: Fortimel Extra®; Dietary supplement: Fortimel Care®

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Department of Gastro-entérologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 85 years
• Weight loss between 6 and 10% during the last six months
• Chronic heart failure with end-systolic ejection fraction ≤ 40% (all stages of the NYHA classification)
• Triple therapy: ß-blockers, ACE inhibitors and diuretics
• Informed consent signed
• Affiliated with the French Sécurité Sociale

Exclusion Criteria:

• Patent undernutrition: BMI < 18.5 for ages < 70 or < 21 for ages ≥ 70 and/or weight loss > 10% in the last six months

• Chronic cachectic condition:

  • cancer
  • chronic respiratory failure
  • advanced organ failure
  • hyperthyroidism
  • rheumatoid arthritis
  • AIDS
  • type 1 diabetes
• Drugs affecting muscle mass (e.g., steroids)
• Condition (clinical or EKG) contra-indicating cycle ergometry
• Unstable acute disease
• Edema
• Flare-up of heart failure (BNP > 500 ng/L)
• Intake of omega-3-containing nutritional supplements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Standard oral nutritional supplement	Dietary supplement: Fortimel Extra®; 2 bottles (600 kcal, 40 g proteins) per day
Experimental: 2; Omega-3-enriched oral nutritional supplement	Dietary supplement: Fortimel Care®; Fortimel Care® : 2 bottles (660 kcal, 36 g proteins, 2.38 g EPA) per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VO2 max (cycle ergometry)	D0 and after 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	D0 and after 8 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Stéphane Schneider, PU-PH, Department of Gastroentrology of Nice University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: September 4, 2008
• First Submitted That Met QC Criteria: September 4, 2008
• First Posted (Estimate): September 8, 2008

Study Record Updates

• Last Update Posted (Estimate): August 22, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Wasting Syndrome; Cachexia
• Other Study ID Numbers: API 2007