Effects of Omega-3 Fatty Acids on Muscle Wasting

Study Overview
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Brief Summary
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The risk of muscle wasting, and sarcopenia is high in the intensive care unit patients and associated with adverse clinical outcomes. The etiology of muscle wasting is multifactorial and medical nutrition therapy plays a key role in treatment and prevention. The purpose of this study is to evaluate the effect of omega-3 fatty acids in the treatment and/or prevention of muscle wasting in critically ill trauma patients.

Detailed Description
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Low skeletal muscle mass and loss of lean tissue in critically illness have been associated with negative clinical outcomes. Critically ill patients may lose about 25% of their skeletal muscle mass within 7 days of admission to the intensive care unit. Besides increased protein catabolism, other factors inherent to the ICU environment contribute to muscle loss, including patient immobility and interruptions in nutrient delivery. This combination of factors is especially debilitating in patients with preexisting low muscle stores due to sarcopenia, chronic illness, or malnutrition. Although preservation of skeletal muscle mass is important for recovery in critically ill patients, the mechanism of muscle wasting is not unknown. Muscle wasting is a multifactorial process and it may be the consequence of several events, including oxidative stress, inflammatory conditions and muscle remodeling. Omega-3 fatty acids with their anti-inflammatory, antioxidant and anabolic effects can be a key factor for an effective treatment.

Official Title
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Effects of Omega-3 Fatty Acids on Sarcopenia in Trauma Patients in Intensive Care Unit

Conditions
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Muscle Wasting

Intervention / Treatment
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* Dietary Supplement: omega 3 fatty acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years and ≤80 years, Expected ICU stay of seven days or longer Written informed consent or requirements of local/national ethical committee Exclusion Criteria: Pregnancy or breastfeeding Neuromuscular conditions (e.g., multiple sclerosis, muscular dystrophy, spinal cord injury, Guillain-Barre syndrome) Current cancer or chemotherapy End-stage of renal failure or dialysis treatment or renal transplantation prior to ICU admission Burn injury History of transplantation Pretibial edema Uncontrolled hemorrhage Uncontrolled hyperlipidemia Acute pancreatitis Acute thromboembolic diseases Severe heart failure Septic shock Concurrent enrolment in a nutrition-related interventional study at the time of screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Omega 3 fatty acid<br>Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days. | Dietary Supplement: omega 3 fatty acid<br>* Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days.<br>* Other names: eicosapentaenoic acid (EPA) and docosohexaenoic acid (DHA);|
| Control (standart)<br>Standart medical nutrition therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in rectus femoris muscle cross-sectional area | Will be evaluated by ultrasound. | Baseline and 7 days | 
| Changes in mid-upper arm and calf circumferences | Will be measured by tape measure. | Baseline and 7 days | 
| Changes in triceps and biceps skinfold thickness Changes in triceps and biceps skinfold thickness | Will be measured by caliper. | Baseline and 7 days | 
| Changes in biochemical parameters related to muscle homeostasis, oxidative stress and inflammation | Biochemical parameters related to muscle wasting such as TNF-a, IL-6, TOS, P3NP | Baseline and 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive care unit length of stay | Time from study inclusion to intensive care unit discharge. | Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year | 
| Hospital Length of Stay | Time from study inclusion to hospital discharge. | Time of discharge from the ICU until hospital discharge, up to 1 year | 
| 28-day mortality | Mortality rate | 28 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Illness, Trauma, Fatty Acids, Anthropometry, Nutrition Disorders, Sarcopenia