Chronic Obstructive Pulmonary DiseaseNCT01624792
Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in Chronic Obstructive Pulmonary Disease (COPD): Aim 2
A study testing Olive oil and Fish oil in people with Chronic Obstructive Pulmonary Disease and Muscle Wasting, run by Texas A&M University at 1 site in United States.
Trial summary
Loss of muscle protein is generally a central component of weight loss in Chronic Obstructive Pulmonary Disease (COPD) patients. Gains in muscle mass are difficult to achieve in COPD unless specific metabolic abnormalities are targeted. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Muscle Wasting
- What is being tested?
- Olive oil and Fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2011to 29 Jun 2016
- Phase
- Interventional
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to walk, sit down and stand up independently
- Age 45 years or older
- Ability to lay in supine or elevated position for 8 hours
- Diagnosis of moderate to severe chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) ≤ 70% of referen¬ce FEV1
- Clinically stable condition and not suffering from respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever, and a decrease in FEV1 > 10% compared with values when clinically stable in the preceding year) at least 4 weeks prior to the study
- Shortness of breath on exertion
Show all 17Show fewer
- Willingness and ability to comply with the protocol, including:
- Refraining from alcohol consumption (24 h) and intense physical activities (72h) prior to each study visit
- Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit
- Healthy male or female according to the investigator's or appointed staff's judgment
- Ability to walk, sit down and stand up independently
- Age 45 years or older
- Ability to lay in supine or elevated position for 8 hours
- No diagnosis of COPD and forced expiratory volume in one second (FEV1) > 80% of referen¬ce FEV1
- Willingness and ability to comply with the protocol, including:
- Refraining from alcohol consumption (24 h) and intense physical activities (72h) prior to each study visit
- Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit
Who cannot join
- Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only)
- Established diagnosis of malignancy
- Established diagnosis of Diabetes Mellitus
- History of untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Recent myocardial infarction (less than 1 year)
Show all 21Show fewer
- Any other condition according to the PI or study physicians would interfere with proper conduct of the study / safety of the patient
- BMI ≥ 40 kg/m2
- Dietary or lifestyle characteristics:
- Use of supplements containing EPA+DHA 3 months prior to the first test day Use of protein or amino acid containing nutritional supplements within 5 days of first study day
- Current alcohol or drug abuse
- Indications related to interaction with study products:
- Known allergy to milk or milk products
- Known hypersensitivity to fish and/or shellfish, Swanson EFAs Super EPA Fish oil or any of its ingredients, Swanson EFAs Certified Organic Extra Virgin Olive oil or any of its ingredients
- Contraindications to biopsy procedure:
- Platelet count (PLT) < 100,000
- History of hypo- or hyper-coagulation disorders including use of a Coumadin derivative, history of deep venous thrombosis (DVT), or pulmonary embolism (PE) at any point in lifetime
- Currently taking anti-thrombotics and cannot stop for 7 days (i.e. medical indication)
- Allergy to local anesthetic
- Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
- Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Trial locations and contacts
1 site in 1 country.
About this study
Loss of muscle protein is generally a central component of weight loss in Chronic Obstructive Pulmonary Disease (COPD) patients. Gains in muscle mass are difficult to achieve in COPD unless specific metabolic abnormalities are targeted. The investigators recently observed that alterations in protein metabolism are present in normal weight COPD patients. Elevated levels of protein synthesis and breakdown rates were found in this COPD group indicating that alterations are already present before muscle wasting occurs. The investigators recently observed that in order to enhance protein anabolism, manipulation of the composition of proteins and amino acids in nutrition is required in normal-weight COPD. Intake of casein protein resulted into significant protein anabolism in these patients. The anabolic response to casein protein was even higher than after whey protein intake.
A substantial number of COPD patients, underweight as well as normal weight to obese, is characterized by an increased inflammatory response. This group failed to respond to nutritional therapy. Previous experimental research and clinical studies in cachectic conditions (mostly malignancy) indicate that polyunsaturated fatty acids (PUFA) are able to attenuate protein degradation by improving the anabolic response to feeding and by decreasing the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic acid (DHA)) has been shown to effectively inhibit weight loss in several disease states, however weight and muscle mass gain was not present or minimal.
Read more
Until now, limited research has been done examining muscle protein metabolism and the response to EPA and DHA supplementation in patients with COPD.
It is the investigator's hypothesis that supplementation of 2g/day EPA+DHA in COPD patients during 4 consecutive weeks will increase the muscle anabolic response to a high quality protein supplement as compared to a placebo, and supplementation of 3.5g/day EPA+DHA will increase the anabolic response even further. In the present study both the acute and chronic effects of EPA+DHA versus a placebo on muscle and whole body protein metabolism will be examined. The principal endpoint will be the extent of stimulation of net fractional muscle protein synthesis as this is the principal mechanism by which the effect of EPA+DHA on muscle anabolism can be measured. The endpoint will be assessed by isotope methodology which is thought to be the reference method.
Read the detailed description
Specific aim 1: To test the hypothesis that supplementation of 3.5g EPA+DHA will increase the acute net fractional muscle protein synthesis more in COPD patients as compared to healthy controls in response to a high quality protein supplement.
Specific aim 2: To test the hypothesis that 3.5g/day EPA+DHA for 4 consecutive weeks induces a higher increase in net fractional muscle protein synthesis in response to a high quality protein supplement as compared to 2g/day EPA+DHA in COPD patients.
Therefore, to answer the specific aims in this study only the COPD subjects will undergo a 4-week intervention period.
- Being tested
- Olive oil, Fish oil, Fish oil and placebo
- Keywords
- Protein metabolism, casein protein, EPA, Fish oil
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive oilDietary supplement
Dose: 7.0 g/day (= 7 capsules/day).
Fish oilDietary supplement
Dose: 7.0 g/day (= 7 capsules/day = 3.5g EPA+DHA/day).
Fish oil and placeboDietary supplement
Dose: 7.0 g/day (= 4 capsules/day fish oil = 2.0g EPA+DHA/day and 3 capsules/day olive oil).
| Study group | Role | What they receive |
|---|---|---|
| Healthy older adults | Experimental | Healthy controls will receive each intervention (olive oil or fish oil with 3.5 g EPA+DHA) one time and for only one day per intervention . Receives: Dietary Supplement: Olive oil; Dietary Supplement: Fish oil |
| COPD patients | Experimental | COPD patients will receive one out of three possible interventions (olive oil or fish oil with 3.5 g EPA+DHA or fish oil and placebo with 2 g EPA+DHA) for 4 (+/- 7 days) weeks. Receives: Dietary Supplement: Olive oil; Dietary Supplement: Fish oil; Dietary Supplement: Fish oil and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional muscle protein synthesis and breakdown rate (FSR and FBR) of mixed muscle protein (%/h) and net fractional muscle protein synthesis (nFSR = FSR - FBR)
On the study days the primary outcome measure is determined acutely before and after 4 hours of feeding and after intake of either the 3.5 g EPA+DHA, a placebo or 2.0 g EPA+DHA (last category only applicable to COPD group). After study day 1 COPD patients undergo a 4-week intervention period of daily EPA+DHA or placebo supplementation and on their return visit (2nd study day) the primary outcome measure is determined again.
Measured: Acutely before and after 4 hours of feeding and the change after 4 weeks of EPA+DHA or placebo supplementation
Secondary outcomes (9)
Net whole body protein synthesis (whole body protein synthesis and breakdown rate)
On the study days the primary outcome measure is determined acutely before and after 4 hours of feeding and after intake of either the 3.5 g EPA+DHA, a placebo or 2.0 g EPA+DHA (last category only applicable to COPD group). After study day 1 COPD patients undergo a 4-week intervention period of daily EPA+DHA or placebo supplementation and on their return visit (2nd study day) the primary outcome measure is determined again.
Measured: Acutely before and after 4 hours of feeding and the change after 4 weeks of EPA+DHA or placebo supplementation
Whole body myofibrillar protein breakdown rate
On the study days the primary outcome measure is determined acutely before and after 4 hours of feeding and after intake of either the 3.5 g EPA+DHA, a placebo or 2.0 g EPA+DHA (last category only applicable to COPD group). After study day 1 COPD patients undergo a 4-week intervention period of daily EPA+DHA or placebo supplementation and on their return visit (2nd study day) the primary outcome measure is determined again.
Measured: Acutely before and after 4 hours of feeding and the change after 4 weeks of EPA+DHA or placebo supplementation
Glutathione turnover
On the study days the primary outcome measure is determined acutely before and after 4 hours of feeding and after intake of either the 3.5 g EPA+DHA, a placebo or 2.0 g EPA+DHA (last category only applicable to COPD group). After study day 1 COPD patients undergo a 4-week intervention period of daily EPA+DHA or placebo supplementation and on their return visit (2nd study day) the primary outcome measure is determined again.
Measured: Acutely before and after 4 hours of feeding and the change after 4 weeks of EPA+DHA or placebo supplementation
Body composition
Body composition as measured by Dual-Energy X-ray Absorptiometry. Determined on study day 1 and after 4 weeks on study day 2 for COPD patients.
Measured: On study day 1 and the change from study day 1 on study day 2
Skeletal and respiratory muscle strength and fatigue
Determined on study day 1 and after 4 weeks on study day 2 for COPD patients.
Measured: On study day 1 and the change from study day 1 on study day 2
Inflammatory profile (CRP, IL6, IL1b, TNFα, IL8 and IL10)
Determined on study day 1 and after 4 weeks on study day 2 for COPD patients.
Measured: On study day 1 and the change from study day 1 on study day 2
Other plasma products
Insulin, glucose, urea, cortisol, lactate, blood fatty acid profile (EPA, DHA, arachidonic acid, protectins and resolvins). Some of the parameters are measured on a single occasion and others are measured repeatedly during 10 hours on each study day (e.g. insulin and glucose). Determined on study day 1 and after 4 weeks on study day 2 for COPD patients.
Measured: On study day 1 and the change from study day 1 on study day 2
Oxidative capacity
Oxidative capacity, including peroxisome proliferator-activated receptor (PPAR) and muscle fiber typing. Determined before and after 4 hours of feeding.
Measured: On study day 1 and 2
Molecular markers (mTOR) of muscle wasting
Measured: On study day 1 and the change from study day 1 on study day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study start25 Oct 2011
- Primary completion29 Jun 2016
- Study completion29 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle Engelen, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624792
- Sponsor's protocol ID
- 2012-0171
- Status last verified
- Sep 2025
- First submitted
- 5 Jun 2012
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
PubMed 42149813Kang MC, Deutz NEP, Kirschner SK, Engelen MPKJ. Metabolic kinetics and muscle and brain health markers in older adults, and the role of age and presence of chronic morbidities: A large cross-sectional cohort study. Clin Nutr. 2024 Dec;43(12):36-47. doi: 10.1016/j.clnu.2024.10.015. Epub 2024 Oct 11.
PubMed 39423760Engelen MPKJ, Kirschner SK, Coyle KS, Argyelan D, Neal G, Dasarathy S, Deutz NEP. Sex related differences in muscle health and metabolism in chronic obstructive pulmonary disease. Clin Nutr. 2023 Sep;42(9):1737-1746. doi: 10.1016/j.clnu.2023.06.031. Epub 2023 Jul 26.
PubMed 37542951Engelen MPKJ, Jonker R, Sulaiman H, Fisk HL, Calder PC, Deutz NEP. omega-3 polyunsaturated fatty acid supplementation improves postabsorptive and prandial protein metabolism in patients with chronic obstructive pulmonary disease: a randomized clinical trial. Am J Clin Nutr. 2022 Sep 2;116(3):686-698. doi: 10.1093/ajcn/nqac138.
PubMed 35849009
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in Chronic Obstructive Pulmonary Disease (COPD): Aim 2
- ClinicalTrials.gov ID
- NCT01624792
- Acronym / sponsor ID
- 2012-0171
- Keywords
- Protein metabolism, casein protein, EPA, Fish oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 25 Oct 2011 (actual)
- Primary completion
- 29 Jun 2016 (actual)
- Study completion
- 29 Jun 2016 (actual)
- First posted
- 21 Jun 2012 (estimated)
- 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.
Loss of muscle protein is generally a central component of weight loss in Chronic Obstructive Pulmonary Disease (COPD) patients. Gains in muscle mass are difficult to achieve in COPD unless specific metabolic abnormalities are targeted. The investigators recently observed that alterations in protein metabolism are present in normal weight COPD patients. Elevated levels of protein synthesis and breakdown rates were found in this COPD group indicating that alterations are already present before muscle wasting occurs. The investigators recently observed that in order to enhance protein anabolism, manipulation of the composition of proteins and amino acids in nutrition is required in normal-weight COPD. Intake of casein protein resulted into significant protein anabolism in these patients. The anabolic response to casein protein was even higher than after whey protein intake.
A substantial number of COPD patients, underweight as well as normal weight to obese, is characterized by an increased inflammatory response. This group failed to respond to nutritional therapy. Previous experimental research and clinical studies in cachectic conditions (mostly malignancy) indicate that polyunsaturated fatty acids (PUFA) are able to attenuate protein degradation by improving the anabolic response to feeding and by decreasing the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic acid (DHA)) has been shown to effectively inhibit weight loss in several disease states, however weight and muscle mass gain was not present or minimal.
Until now, limited research has been done examining muscle protein metabolism and the response to EPA and DHA supplementation in patients with COPD.
It is the investigator's hypothesis that supplementation of 2g/day EPA+DHA in COPD patients during 4 consecutive weeks will increase the muscle anabolic response to a high quality protein supplement as compared to a placebo, and supplementation of 3.5g/day EPA+DHA will increase the anabolic response even further. In the present study both the acute and chronic effects of EPA+DHA versus a placebo on muscle and whole body protein metabolism will be examined. The principal endpoint will be the extent of stimulation of net fractional muscle protein synthesis as this is the principal mechanism by which the effect of EPA+DHA on muscle anabolism can be measured. The endpoint will be assessed by isotope methodology which is thought to be the reference method.
Detailed description
Specific aim 1: To test the hypothesis that supplementation of 3.5g EPA+DHA will increase the acute net fractional muscle protein synthesis more in COPD patients as compared to healthy controls in response to a high quality protein supplement.
Specific aim 2: To test the hypothesis that 3.5g/day EPA+DHA for 4 consecutive weeks induces a higher increase in net fractional muscle protein synthesis in response to a high quality protein supplement as compared to 2g/day EPA+DHA in COPD patients.
Therefore, to answer the specific aims in this study only the COPD subjects will undergo a 4-week intervention period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy older adults | Experimental | Dietary Supplement: Olive oil, Dietary Supplement: Fish oilHealthy controls will receive each intervention (olive oil or fish oil with 3.5 g EPA+DHA) one time and for only one day per intervention . |
| COPD patients | Experimental | Dietary Supplement: Olive oil, Dietary Supplement: Fish oil, Dietary Supplement: Fish oil and placeboCOPD patients will receive one out of three possible interventions (olive oil or fish oil with 3.5 g EPA+DHA or fish oil and placebo with 2 g EPA+DHA) for 4 (+/- 7 days) weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Ability to walk, sit down and stand up independently
- Age 45 years or older
- Ability to lay in supine or elevated position for 8 hours
- Diagnosis of moderate to severe chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) ≤ 70% of referen¬ce FEV1
- Clinically stable condition and not suffering from respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever, and a decrease in FEV1 > 10% compared with values when clinically stable in the preceding year) at least 4 weeks prior to the study
Key exclusion criteria (21 listed)
- Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only)
- Established diagnosis of malignancy
- Established diagnosis of Diabetes Mellitus
- History of untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
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 |
|---|---|---|
| Olive oilDose: 7.0 g/day (= 7 capsules/day). | Dietary supplement | COPD patients, Healthy older adults |
| Fish oilDose: 7.0 g/day (= 7 capsules/day = 3.5g EPA+DHA/day). | Dietary supplement | COPD patients, Healthy older adults |
| Fish oil and placeboDose: 7.0 g/day (= 4 capsules/day fish oil = 2.0g EPA+DHA/day and 3 capsules/day olive oil). | Dietary supplement | COPD patients |
Primary outcome
Fractional muscle protein synthesis and breakdown rate (FSR and FBR) of mixed muscle protein (%/h) and net fractional muscle protein synthesis (nFSR = FSR - FBR)
Time frame: Acutely before and after 4 hours of feeding and the change after 4 weeks of EPA+DHA or placebo supplementation
On the study days the primary outcome measure is determined acutely before and after 4 hours of feeding and after intake of either the 3.5 g EPA+DHA, a placebo or 2.0 g EPA+DHA (last category only applicable to COPD group). After study day 1 COPD patients undergo a 4-week intervention period of daily EPA+DHA or placebo supplementation and on their return visit (2nd study day) the primary outcome measure is determined again.
9 secondary outcomes
Net whole body protein synthesis (whole body protein synthesis and breakdown rate)
Time frame: Acutely before and after 4 hours of feeding and the change after 4 weeks of EPA+DHA or placebo supplementation
Whole body myofibrillar protein breakdown rate
Time frame: Acutely before and after 4 hours of feeding and the change after 4 weeks of EPA+DHA or placebo supplementation
Glutathione turnover
Time frame: Acutely before and after 4 hours of feeding and the change after 4 weeks of EPA+DHA or placebo supplementation
Body composition
Time frame: On study day 1 and the change from study day 1 on study day 2
Skeletal and respiratory muscle strength and fatigue
Time frame: On study day 1 and the change from study day 1 on study day 2
Inflammatory profile (CRP, IL6, IL1b, TNFα, IL8 and IL10)
Time frame: On study day 1 and the change from study day 1 on study day 2
Other plasma products
Time frame: On study day 1 and the change from study day 1 on study day 2
Oxidative capacity
Time frame: On study day 1 and 2
Molecular markers (mTOR) of muscle wasting
Time frame: On study day 1 and the change from study day 1 on study day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 42149813Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
- Derived from this study: PubMed 39423760Kang MC, Deutz NEP, Kirschner SK, Engelen MPKJ. Metabolic kinetics and muscle and brain health markers in older adults, and the role of age and presence of chronic morbidities: A large cross-sectional cohort study. Clin Nutr. 2024 Dec;43(12):36-47. doi: 10.1016/j.clnu.2024.10.015. Epub 2024 Oct 11.
- Derived from this study: PubMed 37542951Engelen MPKJ, Kirschner SK, Coyle KS, Argyelan D, Neal G, Dasarathy S, Deutz NEP. Sex related differences in muscle health and metabolism in chronic obstructive pulmonary disease. Clin Nutr. 2023 Sep;42(9):1737-1746. doi: 10.1016/j.clnu.2023.06.031. Epub 2023 Jul 26.
- Derived from this study: PubMed 35849009Engelen MPKJ, Jonker R, Sulaiman H, Fisk HL, Calder PC, Deutz NEP. omega-3 polyunsaturated fatty acid supplementation improves postabsorptive and prandial protein metabolism in patients with chronic obstructive pulmonary disease: a randomized clinical trial. Am J Clin Nutr. 2022 Sep 2;116(3):686-698. doi: 10.1093/ajcn/nqac138.
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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.
Marielle Engelen, PhD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive oil and Fish oil in people with Chronic Obstructive Pulmonary Disease and Muscle Wasting, run by Texas A&M University at 1 site in United States.
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 17 inclusion and 21 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: finished, as of the sponsor's last update on 30 Sep 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fractional muscle protein synthesis and breakdown rate (FSR and FBR) of mixed muscle protein (%/h) and net fractional muscle protein synthesis (nFSR = FSR - FBR) (time frame: Acutely before and after 4 hours of feeding and the change after 4 weeks of EPA+DHA or placebo supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01624792, which also lists 4 linked publications.
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 30 Sep 2025.