Effects of Omega-3 Fatty Acids on Muscle Wasting

Overview

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.

Full Title of Study: “Effects of Omega-3 Fatty Acids on Sarcopenia in Trauma Patients in Intensive Care Unit”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 20, 2021

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.

Interventions

  • Dietary Supplement: omega 3 fatty acid
    • Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days.

Arms, Groups and Cohorts

  • Omega 3 fatty acid
    • Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days.
  • Control (standart)
    • Standart medical nutrition therapy

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Intensive care unit length of stay
    • Time Frame: 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.
  • Hospital Length of Stay
    • Time Frame: Time of discharge from the ICU until hospital discharge, up to 1 year
    • Time from study inclusion to hospital discharge.
  • 28-day mortality
    • Time Frame: 28 day
    • Mortality rate

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karadeniz Technical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hulya ULUSOY, Clinical Professor – Karadeniz Technical University
  • Overall Official(s)
    • Ahmet Oguzhan Kucuk, MD, Principal Investigator, Karadeniz Technical University
    • Melda Kangalgil, MSc, Principal Investigator, Karadeniz Technical University
    • Kıvanc Oncu, MD, Principal Investigator, Karadeniz Technical University
    • Serap Ozer Yaman, PhD, Principal Investigator, Karadeniz Technical University
    • Sekine Turan, MD, Principal Investigator, Karadeniz Technical University
    • Süleyman Caner Karahan, MD, Principal Investigator, Karadeniz Technical University

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