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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00748332
First received: September 4, 2008
Last updated: August 21, 2012
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Cardiac Cachexia
Dietary Supplement: Fortimel Extra®
Dietary Supplement: Fortimel Care®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • VO2 max (cycle ergometry) [ Time Frame: D0 and after 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: March 2008
Study Completion Date: August 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748332

Locations
France
Department of Gastro-entérologie
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Stéphane Schneider, PU-PH Department of Gastroentrology of Nice University Hospital
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00748332     History of Changes
Other Study ID Numbers: API 2007
Study First Received: September 4, 2008
Last Updated: August 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Institutional Ethical Committee
France: Ministry of Health

Additional relevant MeSH terms:
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014