Effects of Omega-3 Fatty Acids on Muscle Wasting

NCT04582630 | Unknown

• 1 other identifier: Karadeniz TU
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Wasting

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

• Hospital Length of Stay

  Time of discharge from the ICU until hospital discharge, up to 1 year

• 28-day mortality

  28 day

Study Arms (2)

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

Control (standart)

Standart medical nutrition therapy

Interventions

omega 3 fatty acid DIETARY_SUPPLEMENT

Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days.

Also known as: eicosapentaenoic acid (EPA) and docosohexaenoic acid (DHA)

Omega 3 fatty acid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age ≥18 years and ≤80 years, Expected ICU stay of seven days or longer Written informed consent or requirements of local/national ethical committee

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation

Trabzon, 61100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Muscular Atrophy; Critical Illness; Wounds and Injuries; Nutrition Disorders; Sarcopenia

Interventions

Fatty Acids, Omega-3; Eicosapentaenoic Acid

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes; Pathologic Processes; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Eicosanoids

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: October 9, 2020
• Study Start: July 20, 2020
• Primary Completion: July 20, 2021
• Study Completion: December 20, 2021
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)