Effects of Omega-3 Fatty Acids on Muscle Wasting

• ClinicalTrials.gov Identifier: NCT04582630
• Recruitment Status: Enrolling by invitation
• First Posted: October 9, 2020
• Last Update Posted: October 14, 2020
• Sponsor: Karadeniz Technical University
• Information provided by (Responsible Party): Hulya ULUSOY, Karadeniz Technical University

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
Muscle Wasting	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
• Estimated 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: July 20, 2020
• Estimated Primary Completion Date: July 20, 2021
• Estimated Study Completion Date: December 20, 2021

Groups and Cohorts

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 Name: 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 [ Time Frame: Baseline and 7 days ]
   Will be evaluated by ultrasound.
2. Changes in mid-upper arm and calf circumferences [ Time Frame: 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 [ Time Frame: Baseline and 7 days ]
   Will be measured by caliper.
4. 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 Outcome Measures :

1. 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.
2. 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.
3. 28-day mortality [ Time Frame: 28 day ]
   Mortality rate

Biospecimen Retention:   Samples Without DNA

TNF-a, IL-6, TOS, P3NP levels in muscle wasting

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

Criteria

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

Turkey

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

More Information

• Responsible Party: Hulya ULUSOY, Clinical Professor, Karadeniz Technical University
• ClinicalTrials.gov Identifier: NCT04582630
• Other Study ID Numbers: Karadeniz TU
• First Posted: October 9, 2020
• Last Update Posted: October 14, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• 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, Karadeniz Technical University:

Critical Illness; Trauma; Fatty Acids; Anthropometry; Nutrition Disorders; Sarcopenia

Additional relevant MeSH terms:

Muscular Atrophy; Wasting Syndrome; Cachexia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Emaciation; Weight Loss; Body Weight Changes; Body Weight; Metabolic Diseases; Nutrition Disorders