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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT04459156
Eligibility Criteria:
Inclusion Criteria:
* 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 - 100 years for healthy control subjects
* Age 18 - 30 years for healthy, young adults
* Ability to lay in supine or elevated position for 1.5 hours
* No diagnosis of COPD
* Willingness and ability to comply with the protocol
Inclusion criteria COPD subjects:
* Ability to walk, sit down and stand up independently
* Age 45 - 100 years
* Ability to lie in supine or elevated position for 1.5 hours
* Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 \< 70% of reference FEV1
* Clinically stable condition and not suffering from a 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 first test day
* Shortness of breath on exertion
* Willingness and ability to comply with the protocol
Exclusion criteria all subjects:
* Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
* Insulin dependent diabetes mellitus
* Established diagnosis of malignancy
* History of untreated metabolic diseases including hepatic or renal disorder
* Presence of acute illness or metabolically unstable chronic illness
* Presence of fever within the last 3 days
* Use of short course of oral corticosteroids within 4 weeks preceding study day
* Dietary or lifestyle characteristics:
* Daily use of fiber supplements 1 week prior to the first test day
* Daily use of protein supplements 5 days prior to each test day
* Indications related to interaction with study products:
* Known allergy to inulin or inulin products
* Known hypersensitivity to inulin or maltodextrin or any of its ingredients
* Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* (Possible) pregnancy
* Already enrolled in another clinical trial and that clinical trial interferes with participating in this study
* Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04459156
Study Brief:
Protocol Section:
NCT04459156