Chronic Obstructive Pulmonary DiseaseNCT01173354
EAA Intake to Optimize Protein Anabolism in COPD
A study testing Free balanced amino acid mixture and Free essential amino acid mixture in people with Chronic Obstructive Pulmonary Disease, run by Texas A&M University at 1 site in United States.
Trial summary
Weight loss commonly occurs in patients with chronic obstructive pulmonary disease (COPD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in COPD patients. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Free balanced amino acid mixture and Free essential amino acid mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2009to 17 Feb 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) less than 70% of reference FEV1
- Shortness of breath on exertion
- Age 45 years and older
- 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
- Ability to lie in supine position for 6 hours
Who cannot join
- Established diagnosis of malignancy
- Presence of fever within the last 3 days
- Established diagnosis of Diabetes Mellitus
- 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 9Show fewer
- Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
- Any other condition according to the PI or study physicians would interfere with proper conduct of the study / safety of the patient
- Failure to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Essential Amino Acid Intake to Optimize Protein Anabolism in Elderly COPD Patients
Weight loss commonly occurs in patients with chronic obstructive pulmonary disease (COPD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in COPD patients. Attempts to reverse muscle loss in COPD by supplying large amounts of protein or calories to these patients have been unsuccessful. 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. Furthermore, reduced plasma essential amino acid (EAA) levels were observed in COPD patients. These reduced EAA plasma levels were significantly related with the presence of muscle wasting in COPD. Until now, limited research has been done examining protein metabolism and the response to feeding in patients with COPD. Previous studies support the concept of essential amino acids (EAA) as an anabolic stimulus in the young and elderly and in insulin resistant states. Until yet no information is present on the anabolic effects of EAA in elderly COPD patients.
It is therefore our hypothesis that a high-leucine essential amino acids mixture specifically designed to stimulate protein anabolism will target the metabolic alterations of COPD patients. In the present study, the acute effects of an EAA nutritional supplement on whole body, muscle and liver protein metabolism will be examined in COPD patients and compared to a supplement consisting of a balanced mixture of total amino acids. The principal endpoints will be the extent of stimulation of whole body protein synthesis as this is the principal mechanism by which either amino acid or protein intake causes muscle anabolism, and the reduction in endogenous protein breakdown. Both endpoints will be assessed by isotope methodology which is thought to be the reference method.
Read the detailed description
In this study the investigators will test the following hypothesis: A high-leucine essential amino acid mixture (dose of 7.0 g EAA + 15 g carbohydrates) will stimulate protein anabolism to a greater extent than a standard balanced mixture of total (essential and non-essential) amino acids (dose of 6.7 g total AA + 15 g carbohydrates) in COPD patients. The principal endpoints will be the extent of stimulation of protein synthesis rate and the reduction in endogenous protein breakdown. The current project will provide information that will enable us to better understand the underlying metabolic mechanisms that regulate protein metabolism in patients with COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Free balanced amino acid mixture, Free essential amino acid mixture
- Keywords
- COPD, Protein metabolism, Essential amino acid intake
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free balanced amino acid mixtureDietary supplement
Also called 7 g AA (24% leucine of the EAA is leucine)
7 g free amino acids provided as a one time bolus, including 15 g carbohydrates. As part of the total amount of essential amino acids 24% is leucine.
Free essential amino acid mixtureDietary supplement
Also called 7 g EAA (including 40% leucine)
7 g free essential amino acids provided as a one time bolus, including 15 g carbohydrates. As part of the total amount of essential amino acids 40% is leucine.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients only | Experimental | Free balanced amino acid mixture or free essential amino acid mixture Receives: Dietary Supplement: Free balanced amino acid mixture; Dietary Supplement: Free essential amino acid mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net whole body protein synthesis rate
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 2 years
Secondary outcomes (10)
Whole body collagen breakdown rate
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 3 years
Urea turnover rate
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 3 years
Arginine turnover rate
Measured in postabsorptive state
Measured: Up to 3 years
Muscle protein breakdown
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 3 years
Amino acid kinetics
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 3 years
Liver protein synthesis rate
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 3 years
Resting Energy expenditure
Measured in postabsorptive state
Measured: Up to 3 years
Insulin kinetics
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 3 years
Glucose kinetics
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 3 years
Fat-free mass
Characterization of subjects
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study start8 Sep 2009
- Primary completion17 Feb 2012
- Study completion17 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 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 PK Engelen, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173354
- Sponsor's protocol ID
- 105558
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2010
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Engelen 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 37542951Jonker R, Deutz NE, Erbland ML, Anderson PJ, Engelen MP. Alterations in whole-body arginine metabolism in chronic obstructive pulmonary disease. Am J Clin Nutr. 2016 Jun;103(6):1458-64. doi: 10.3945/ajcn.115.125187. Epub 2016 May 4.
PubMed 27146652
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
- Essential Amino Acid Intake to Optimize Protein Anabolism in Elderly COPD Patients
- ClinicalTrials.gov ID
- NCT01173354
- Acronym / sponsor ID
- 105558
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Protein metabolism, Essential amino acid intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 8 Sep 2009 (actual)
- Primary completion
- 17 Feb 2012 (actual)
- Study completion
- 17 Feb 2012 (actual)
- First posted
- 2 Aug 2010 (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.
Weight loss commonly occurs in patients with chronic obstructive pulmonary disease (COPD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in COPD patients. Attempts to reverse muscle loss in COPD by supplying large amounts of protein or calories to these patients have been unsuccessful. 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. Furthermore, reduced plasma essential amino acid (EAA) levels were observed in COPD patients. These reduced EAA plasma levels were significantly related with the presence of muscle wasting in COPD. Until now, limited research has been done examining protein metabolism and the response to feeding in patients with COPD. Previous studies support the concept of essential amino acids (EAA) as an anabolic stimulus in the young and elderly and in insulin resistant states. Until yet no information is present on the anabolic effects of EAA in elderly COPD patients.
It is therefore our hypothesis that a high-leucine essential amino acids mixture specifically designed to stimulate protein anabolism will target the metabolic alterations of COPD patients. In the present study, the acute effects of an EAA nutritional supplement on whole body, muscle and liver protein metabolism will be examined in COPD patients and compared to a supplement consisting of a balanced mixture of total amino acids. The principal endpoints will be the extent of stimulation of whole body protein synthesis as this is the principal mechanism by which either amino acid or protein intake causes muscle anabolism, and the reduction in endogenous protein breakdown. Both endpoints will be assessed by isotope methodology which is thought to be the reference method.
Detailed description
In this study the investigators will test the following hypothesis: A high-leucine essential amino acid mixture (dose of 7.0 g EAA + 15 g carbohydrates) will stimulate protein anabolism to a greater extent than a standard balanced mixture of total (essential and non-essential) amino acids (dose of 6.7 g total AA + 15 g carbohydrates) in COPD patients. The principal endpoints will be the extent of stimulation of protein synthesis rate and the reduction in endogenous protein breakdown. The current project will provide information that will enable us to better understand the underlying metabolic mechanisms that regulate protein metabolism in patients with COPD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients only | Experimental | Dietary Supplement: Free balanced amino acid mixture, Dietary Supplement: Free essential amino acid mixtureFree balanced amino acid mixture or free essential amino acid mixture |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) less than 70% of reference FEV1
- Shortness of breath on exertion
- Age 45 years and older
- 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
- Ability to lie in supine position for 6 hours
Key exclusion criteria (9 listed)
- Established diagnosis of malignancy
- Presence of fever within the last 3 days
- Established diagnosis of Diabetes Mellitus
- 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 |
|---|---|---|
| Free balanced amino acid mixtureAlso: 7 g AA (24% leucine of the EAA is leucine)7 g free amino acids provided as a one time bolus, including 15 g carbohydrates. As part of the total amount of essential amino acids 24% is leucine. | Dietary supplement | COPD patients only |
| Free essential amino acid mixtureAlso: 7 g EAA (including 40% leucine)7 g free essential amino acids provided as a one time bolus, including 15 g carbohydrates. As part of the total amount of essential amino acids 40% is leucine. | Dietary supplement | COPD patients only |
Primary outcome
Net whole body protein synthesis rate
Time frame: Up to 2 years
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
10 secondary outcomes
Whole body collagen breakdown rate
Time frame: Up to 3 years
Urea turnover rate
Time frame: Up to 3 years
Arginine turnover rate
Time frame: Up to 3 years
Muscle protein breakdown
Time frame: Up to 3 years
Amino acid kinetics
Time frame: Up to 3 years
Liver protein synthesis rate
Time frame: Up to 3 years
Resting Energy expenditure
Time frame: Up to 3 years
Insulin kinetics
Time frame: Up to 3 years
Glucose kinetics
Time frame: Up to 3 years
Fat-free mass
Time frame: Up to 3 years
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 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 27146652Jonker R, Deutz NE, Erbland ML, Anderson PJ, Engelen MP. Alterations in whole-body arginine metabolism in chronic obstructive pulmonary disease. Am J Clin Nutr. 2016 Jun;103(6):1458-64. doi: 10.3945/ajcn.115.125187. Epub 2016 May 4.
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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 PK Engelen, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free balanced amino acid mixture and Free essential amino acid mixture in people with Chronic Obstructive Pulmonary Disease, 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 5 inclusion and 9 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?
Net whole body protein synthesis rate (time frame: Up to 2 years). 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 NCT01173354, which also lists 2 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.