Status:
COMPLETED
Fiber Metabolism in Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Texas A&M University
Conditions:
Chronic Obstructive Pulmonary Disease
Aging
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The impact of fiber intake on short chain fatty acid (SCFA) metabolism has not been studied in subjects suffering from COPD. The purpose of this study is to compare changes in SCFA metabolism after in...
Detailed Description
Dietary fibers are indigestible carbohydrates, which are present in several daily foods such as beans, legumes, whole grain products, and whole fruits and vegetables. The Food and Drug Administration ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04459156
Start Date
June 23 2020
End Date
March 10 2023
Last Update
September 30 2025
Active Locations (1)
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1
Texas A&M University-CTRAL
College Station, Texas, United States, 77845