Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in Chronic Obstructive Pulmonary Disease (COPD): Aim 2

This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring Protein metabolism, casein protein, EPA, Fish oil Read More

Inclusion Criteria:

Inclusion criteria COPD subjects:

• Ability to walk, sit down and stand up independently
• Age 45 years or older
• Ability to lay in supine or elevated position for 8 hours
• Diagnosis of moderate to severe chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) ≤ 70% of referen¬ce FEV1
• 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
• Shortness of breath on exertion

• Willingness and ability to comply with the protocol, including:

  • Refraining from alcohol consumption (24 h) and intense physical activities (72h) prior to each study visit
  • Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit

Inclusion criteria healthy control subjects:

• Healthy male or female according to the investigator's or appointed staff's judgment
• Ability to walk, sit down and stand up independently
• Age 45 years or older
• Ability to lay in supine or elevated position for 8 hours
• No diagnosis of COPD and forced expiratory volume in one second (FEV1) > 80% of referen¬ce FEV1

• Willingness and ability to comply with the protocol, including:

  • Refraining from alcohol consumption (24 h) and intense physical activities (72h) prior to each study visit
  • Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit

Exclusion Criteria:

• Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only)
• Established diagnosis of malignancy
• Established diagnosis of Diabetes Mellitus
• History of untreated metabolic diseases including hepatic or renal disorder
• Presence of acute illness or metabolically unstable chronic illness
• Recent myocardial infarction (less than 1 year)
• Any other condition according to the PI or study physicians would interfere with proper conduct of the study / safety of the patient
• BMI ≥ 40 kg/m2

• Dietary or lifestyle characteristics:

  • Use of supplements containing EPA+DHA 3 months prior to the first test day Use of protein or amino acid containing nutritional supplements within 5 days of first study day
  • Current alcohol or drug abuse

• Indications related to interaction with study products:

  • Known allergy to milk or milk products
  • Known hypersensitivity to fish and/or shellfish, Swanson EFAs Super EPA Fish oil or any of its ingredients, Swanson EFAs Certified Organic Extra Virgin Olive oil or any of its ingredients

• Contraindications to biopsy procedure:

  • Platelet count (PLT) < 100,000
  • History of hypo- or hyper-coagulation disorders including use of a Coumadin derivative, history of deep venous thrombosis (DVT), or pulmonary embolism (PE) at any point in lifetime
  • Currently taking anti-thrombotics and cannot stop for 7 days (i.e. medical indication)
  • Allergy to local anesthetic
• Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
• Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements