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

Cardiac Cachexia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00748332
• Other study ID #: API 2007
• Status: Terminated
• Phase: Phase 3
• First received: September 4, 2008
• Last updated: August 21, 2012
• Start date: March 2008
• Est. completion date: August 2012

Study information

• Verified date: June 2009
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Direction Générale de la SantéFrance: French Data Protection AuthorityFrance: Institutional Ethical CommitteeFrance: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cachexia
• Cardiac Cachexia

Intervention

Dietary Supplement:
• Fortimel Extra®
2 bottles (600 kcal, 40 g proteins) per day
• Fortimel Care®
Fortimel Care® : 2 bottles (660 kcal, 36 g proteins, 2.38 g EPA) per day

Locations

Country	Name	City	State
France	Department of Gastro-entérologie	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 max (cycle ergometry)		D0 and after 8 weeks	No
Secondary	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	No