Muscle WastingNCT04582630
Effects of Omega-3 Fatty Acids on Muscle Wasting
An observational study of Muscle Wasting, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Muscle Wasting
- What is being tested?
- omega 3 fatty acid
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2020to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill trauma patients aged between 18 - 80 years of both sexes
Who may be able to join
- Age ≥18 years and ≤80 years, Expected ICU stay of seven days or longer Written informed consent or requirements of local/national ethical committee
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation
Trabzon, 61100
About this study
Official title: Effects of Omega-3 Fatty Acids on Sarcopenia in Trauma Patients in Intensive Care Unit
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.
Read the 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.
- Conditions
- Muscle Wasting
- Being tested
- omega 3 fatty acid
- Keywords
- Critical Illness, Trauma, Fatty Acids, Anthropometry, Nutrition Disorders, Sarcopenia
- Medical subject headings
- Muscular Atrophy, Critical Illness, Wounds and Injuries, Nutrition Disorders, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega 3 fatty acidDietary supplement
Also called eicosapentaenoic acid (EPA) and docosohexaenoic acid (DHA)
Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 fatty acid | Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days. Receives: Dietary Supplement: omega 3 fatty acid | |
| Control (standart) | Standart medical nutrition therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in rectus femoris muscle cross-sectional area
Will be evaluated by ultrasound.
Measured: Baseline and 7 days
Changes in mid-upper arm and calf circumferences
Will be measured by tape measure.
Measured: Baseline and 7 days
Changes in triceps and biceps skinfold thickness Changes in triceps and biceps skinfold thickness
Will be measured by caliper.
Measured: 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
Measured: Baseline and 7 days
Secondary outcomes (3)
Intensive care unit length of stay
Time from study inclusion to intensive care unit discharge.
Measured: 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 from study inclusion to hospital discharge.
Measured: Time of discharge from the ICU until hospital discharge, up to 1 year
28-day mortality
Mortality rate
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start20 Jul 2020
- Primary completion20 Jul 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hulya ULUSOY, Karadeniz Technical University
- Investigators
- Ahmet Oguzhan Kucuk, MD, Principal investigator, Karadeniz Technical UniversityMelda Kangalgil, MSc, Principal investigator, Karadeniz Technical UniversityKıvanc Oncu, MD, Principal investigator, Karadeniz Technical UniversitySerap Ozer Yaman, PhD, Principal investigator, Karadeniz Technical UniversitySekine Turan, MD, Principal investigator, Karadeniz Technical UniversitySüleyman Caner Karahan, MD, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582630
- Sponsor's protocol ID
- Karadeniz TU
- Status last verified
- Oct 2020
- First submitted
- 22 Jul 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 Fatty Acids on Sarcopenia in Trauma Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04582630
- Acronym / sponsor ID
- Karadeniz TU
- Conditions
- Muscle Wasting
- Keywords
- Critical Illness, Trauma, Fatty Acids, Anthropometry, Nutrition Disorders, Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 20 Jul 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 fatty acid | – | Dietary Supplement: omega 3 fatty acidParticipants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days. |
| Control (standart) | – | –Standart medical nutrition therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill trauma patients aged between 18 - 80 years of both sexes
Key inclusion criteria (1 listed)
- Age ≥18 years and ≤80 years, Expected ICU stay of seven days or longer Written informed consent or requirements of local/national ethical committee
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega 3 fatty acidAlso: eicosapentaenoic acid (EPA) and docosohexaenoic acid (DHA)Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days. | Dietary supplement | Omega 3 fatty acid |
Primary outcome
Changes in rectus femoris muscle cross-sectional area
Time frame: Baseline and 7 days
Will be evaluated by ultrasound.
Changes in mid-upper arm and calf circumferences
Time frame: Baseline and 7 days
Will be measured by tape measure.
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.
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
3 secondary outcomes
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
Hospital Length of Stay
Time frame: Time of discharge from the ICU until hospital discharge, up to 1 year
28-day mortality
Time frame: 28 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Oguzhan Kucuk, MD principal investigator
Karadeniz Technical University
Melda Kangalgil, MSc principal investigator
Karadeniz Technical University
Kıvanc Oncu, MD principal investigator
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Wasting, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in rectus femoris muscle cross-sectional area (time frame: Baseline and 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.