Effects of Omega-3 Fatty Acids on Muscle Wasting

Sponsor
Karadeniz Technical University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04582630
Collaborator
(none)
80
1
17
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effects of Omega-3 Fatty Acids on Sarcopenia in Trauma Patients in Intensive Care Unit
Actual Study Start Date :
Jul 20, 2020
Anticipated Primary Completion Date :
Jul 20, 2021
Anticipated Study Completion Date :
Dec 20, 2021

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. Changes in rectus femoris muscle cross-sectional area [Baseline and 7 days]

      Will be evaluated by ultrasound.

    2. Changes in mid-upper arm and calf circumferences [Baseline and 7 days]

      Will be measured by tape measure.

    3. Changes in triceps and biceps skinfold thickness Changes in triceps and biceps skinfold thickness [Baseline and 7 days]

      Will be measured by caliper.

    4. 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

    Secondary Outcome Measures

    1. 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.

    2. Hospital Length of Stay [Time of discharge from the ICU until hospital discharge, up to 1 year]

      Time from study inclusion to hospital discharge.

    3. 28-day mortality [28 day]

      Mortality rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation Trabzon Turkey 61100

    Sponsors and Collaborators

    • Karadeniz Technical University

    Investigators

    • Principal Investigator: Ahmet Oguzhan Kucuk, MD, Karadeniz Technical University
    • Principal Investigator: Melda Kangalgil, MSc, Karadeniz Technical University
    • 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
    • Principal Investigator: Süleyman Caner Karahan, MD, Karadeniz Technical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hulya ULUSOY, Clinical Professor, Karadeniz Technical University
    ClinicalTrials.gov Identifier:
    NCT04582630
    Other Study ID Numbers:
    • Karadeniz TU
    First Posted:
    Oct 9, 2020
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hulya ULUSOY, Clinical Professor, Karadeniz Technical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 14, 2020