Effects of Omega-3 Fatty Acids on Muscle Wasting

NCT ID: NCT04582630

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-20

Study Completion Date

2021-12-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Muscle Wasting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Omega 3 fatty acid

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

omega 3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

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

Control (standart)

Standart medical nutrition therapy

No interventions assigned to this group

Interventions

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omega 3 fatty acid

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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eicosapentaenoic acid (EPA) and docosohexaenoic acid (DHA)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karadeniz Technical University

OTHER

Sponsor Role lead

Responsible Party

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Hulya ULUSOY

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmet Oguzhan Kucuk, MD

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Melda Kangalgil, MSc

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Kıvanc Oncu, MD

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Serap Ozer Yaman, PhD

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Sekine Turan, MD

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Süleyman Caner Karahan, MD

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Locations

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Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Karadeniz TU

Identifier Type: -

Identifier Source: org_study_id

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