Effects of Omega-3 Fatty Acids on Muscle Wasting

Muscle Wasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04582630
• Other study ID #: Karadeniz TU
• Status: Enrolling by invitation
• Start date: July 20, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: October 2020
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Muscle Wasting
• Muscular Atrophy

Intervention

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

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in rectus femoris muscle cross-sectional area	Will be evaluated by ultrasound.	Baseline and 7 days
Primary	Changes in mid-upper arm and calf circumferences	Will be measured by tape measure.	Baseline and 7 days
Primary	Changes in triceps and biceps skinfold thickness Changes in triceps and biceps skinfold thickness	Will be measured by caliper.	Baseline and 7 days
Primary	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	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
Secondary	Hospital Length of Stay	Time from study inclusion to hospital discharge.	Time of discharge from the ICU until hospital discharge, up to 1 year
Secondary	28-day mortality	Mortality rate	28 day