Status:
COMPLETED
Hydrolyzed Casein and Whey Protein Supplementation and the Addition of Leucine to Induce Protein Anabolism in Malnourished COPD Patients
Lead Sponsor:
Texas A&M University
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
The aim of this study is the first aim of a NIH project that consists of 3 aims. The first aim examines the acute effects of two high-quality milk proteins (casein vs. whey) on whole-body and muscle p...
Detailed Description
Cachectic COPD patients are characterized by a decreased muscle protein synthesis and an elevated myofibrillar protein breakdown. A substantial number of these patients, characterized by an enhanced s...
Eligibility Criteria
Inclusion
- Diagnosis of moderate to severe chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) ≤ 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) at least 4 weeks prior to the study
- Cachexia based on the criteria: Body mass index ≤ 25 kg/m2 and/or FFM-Index: FFM/height2 ≤ 17 (males), 15 (females) kg/m2 and/or recent involuntary weight loss
Exclusion
- 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
- Allergy to cow's milk protein
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01154400
Start Date
May 1 2009
End Date
July 1 2011
Last Update
October 15 2012
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205