Effects of Omega-3 Fatty Acids on Muscle Wasting

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

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.

Study Overview

• Status: Unknown
• Conditions: Muscle Wasting
• Intervention / Treatment: Dietary supplement: omega 3 fatty acid

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey, 61100
    • Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill trauma patients aged between 18 - 80 years of both sexes

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Omega 3 fatty acid; Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days.	Dietary supplement: omega 3 fatty acid; Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days.; Other Names: eicosapentaenoic acid (EPA) and docosohexaenoic acid (DHA)
Control (standart); Standart medical nutrition therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Principal Investigator: Kıvanc Oncu, MD, Karadeniz Technical University; Principal Investigator: Serap Ozer Yaman, PhD, Karadeniz Technical University; Principal Investigator: Sekine Turan, MD, Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2020
• Primary Completion (ANTICIPATED): July 20, 2021
• Study Completion (ANTICIPATED): December 20, 2021

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (ACTUAL): October 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Sarcopenia; Critical Illness; Trauma; Nutrition Disorders; Anthropometry; Fatty Acids
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Nutrition Disorders; Body Weight; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Body Weight Changes; Atrophy; Emaciation; Weight Loss; Muscular Atrophy; Wasting Syndrome; Cachexia
• Other Study ID Numbers: Karadeniz TU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No