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OpenTrials
Completed

NCT Number: NCT01173354

EAA Intake to Optimize Protein Anabolism in COPD

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Free balanced amino acid mixture

Dietary Supplement

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.

Other names: 7 g AA (24% leucine of the EAA is leucine)

Free essential amino acid mixture

Dietary Supplement

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.

Other names: 7 g EAA (including 40% leucine)

Primary outcomes

  1. 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

Secondary outcomes

  1. Whole body collagen breakdown rate

    Time frame: Up to 3 years

    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  2. Urea turnover rate

    Time frame: Up to 3 years

    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  3. Arginine turnover rate

    Time frame: Up to 3 years

    Measured in postabsorptive state

  4. Muscle protein breakdown

    Time frame: Up to 3 years

    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  5. Amino acid kinetics

    Time frame: Up to 3 years

    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  6. Liver protein synthesis rate

    Time frame: Up to 3 years

    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  7. Resting Energy expenditure

    Time frame: Up to 3 years

    Measured in postabsorptive state

  8. Insulin kinetics

    Time frame: Up to 3 years

    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  9. Glucose kinetics

    Time frame: Up to 3 years

    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  10. Fat-free mass

    Time frame: Up to 3 years

    Characterization of subjects

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

Essential Amino Acid Intake to Optimize Protein Anabolism in Elderly COPD Patients

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 2, 2010
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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