Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT01624792
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT01624792
Study Brief:
Protocol Section:
NCT01624792