MedDataX Logo

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

NCT ID: NCT00748332

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Cachexia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Standard oral nutritional supplement

Group Type ACTIVE_COMPARATOR

Fortimel Extra®

Intervention Type DIETARY_SUPPLEMENT

2 bottles (600 kcal, 40 g proteins) per day

2

Omega-3-enriched oral nutritional supplement

Group Type EXPERIMENTAL

Fortimel Care®

Intervention Type DIETARY_SUPPLEMENT

Fortimel Care® : 2 bottles (660 kcal, 36 g proteins, 2.38 g EPA) per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fortimel Extra®

2 bottles (600 kcal, 40 g proteins) per day

Intervention Type DIETARY_SUPPLEMENT

Fortimel Care®

Fortimel Care® : 2 bottles (660 kcal, 36 g proteins, 2.38 g EPA) per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stéphane Schneider, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroentrology of Nice University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Gastro-entérologie

Nice, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

API 2007

Identifier Type: -

Identifier Source: org_study_id