EAA Intake to Optimize Protein Anabolism in COPD
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|ClinicalTrials.gov Identifier: NCT01173354|
Recruitment Status : Unknown
Verified September 2017 by Marielle PKJ Engelen, PhD, Texas A&M University.
Recruitment status was: Active, not recruiting
First Posted : August 2, 2010
Last Update Posted : September 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Dietary Supplement: Free balanced amino acid mixture Dietary Supplement: Free essential amino acid mixture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Essential Amino Acid Intake to Optimize Protein Anabolism in Elderly COPD Patients|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2018|
Experimental: COPD patients only
Free balanced amino acid mixture or free essential amino acid mixture
Dietary Supplement: Free balanced amino acid mixture
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 Name: 7 g AA (24% leucine of the EAA is leucine)
Dietary Supplement: Free essential amino acid mixture
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 Name: 7 g EAA (including 40% leucine)
- 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
- 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
- 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
- Arginine turnover rate [ Time Frame: Up to 3 years ]Measured in postabsorptive state
- 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 ]Measured in postabsorptive state
- 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 ]Characterization of subjects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173354
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Marielle PK Engelen, PhD||University of Arkansas|