View Clinical Trial (Medical Research Study)
Essential Amino Acid Intake to Optimize Protein Anabolism in Elderly COPD Patients
| City: |
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Little Rock |
| State: |
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Arkansas |
| Zip Code: |
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72205 |
| Conditions: |
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Chronic Obstructive Pulmonary Disease |
| Purpose: |
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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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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Diagnosis of chronic airflow limitation, defined as measured forced expiratory volume
in one second (FEV1) less than 70% of referen¬ce 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
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| NCT ID: |
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NCT01173354 |
| Primary Contact: |
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Principal Investigator
Marielle PK Engelen, PhD
University of Arkansas
Marielle PK Engelen, PhD
Phone: 501-352-6625
Email: mengelen@uams.edu
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| Backup Contact: |
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Email: deutznep@uams.edu
Nicolaas EP Deutz, MD, PhD
Phone: 501-352-6626
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| Location Contact: |
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Little Rock, Arkansas 72205
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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