Protein-energy Oral Supplementation Enriched With Omega-3 Fatty Acids in Cardiac Cachexia
Primary Purpose
Cardiac Cachexia
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Fortimel Extra®
Fortimel Care®
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Cachexia
Eligibility 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
Sites / Locations
- Department of Gastro-entérologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Standard oral nutritional supplement
Omega-3-enriched oral nutritional supplement
Outcomes
Primary Outcome Measures
VO2 max (cycle ergometry)
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.
Full Information
NCT ID
NCT00748332
First Posted
September 4, 2008
Last Updated
August 21, 2012
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT00748332
Brief Title
Protein-energy Oral Supplementation Enriched With Omega-3 Fatty Acids in Cardiac Cachexia
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Cachexia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard oral nutritional supplement
Arm Title
2
Arm Type
Experimental
Arm Description
Omega-3-enriched oral nutritional supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortimel Extra®
Intervention Description
2 bottles (600 kcal, 40 g proteins) per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortimel Care®
Intervention Description
Fortimel Care® : 2 bottles (660 kcal, 36 g proteins, 2.38 g EPA) per day
Primary Outcome Measure Information:
Title
VO2 max (cycle ergometry)
Time Frame
D0 and after 8 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Schneider, PU-PH
Organizational Affiliation
Department of Gastroentrology of Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastro-entérologie
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
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Protein-energy Oral Supplementation Enriched With Omega-3 Fatty Acids in Cardiac Cachexia
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