Effects of Omega-3 Fatty Acids on Muscle Wasting
- Conditions
- Muscle Wasting
- Interventions
- Dietary Supplement: omega 3 fatty acid
- Registration Number
- NCT04582630
- Lead Sponsor
- Karadeniz Technical University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
Age ≥18 years and ≤80 years, Expected ICU stay of seven days or longer Written informed consent or requirements of local/national ethical committee
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Omega 3 fatty acid omega 3 fatty acid Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days.
- Primary Outcome Measures
Name Time Method Changes in triceps and biceps skinfold thickness Changes in triceps and biceps skinfold thickness Baseline and 7 days Will be measured by caliper.
Changes in mid-upper arm and calf circumferences Baseline and 7 days Will be measured by tape measure.
Changes in biochemical parameters related to muscle homeostasis, oxidative stress and inflammation Baseline and 7 days Biochemical parameters related to muscle wasting such as TNF-a, IL-6, TOS, P3NP
Changes in rectus femoris muscle cross-sectional area Baseline and 7 days Will be evaluated by ultrasound.
- Secondary Outcome Measures
Name Time Method Intensive care unit length of stay Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year Time from study inclusion to intensive care unit discharge.
28-day mortality 28 day Mortality rate
Hospital Length of Stay Time of discharge from the ICU until hospital discharge, up to 1 year Time from study inclusion to hospital discharge.
Trial Locations
- Locations (1)
Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation
🇹🇷Trabzon, Turkey