Fiber Metabolism in Chronic Obstructive Pulmonary Disease
NCT ID: NCT04459156
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2020-06-23
2023-03-10
Brief Summary
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Detailed Description
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In COPD an enhanced pulmonary inflammatory response causes a combination of small airways disease (e.g., obstructive bronchiolitis) and/or a destruction of lung parenchyma (emphysema). This leads to a progressive and persistent airflow limitation. It has been shown that a healthy overall diet as well as a diet high in fiber can be associated with a good lung function and a decreased COPD prevalence. A diet rich in fermentable fiber altered the gut and lung microbiota composition in mice, mainly through a decrease in the Firmicutes-to-Bacteroidetes-ratio, which was accompanied by elevated concentrations of circulating SCFAs. These mice were protected against allergic inflammation in the lungs. Previous human research has demonstrated that the composition of the intestinal microbiota influences the asthma risk and it was associated with early life exacerbations in cystic fibrosis, which demonstrates a gut-lung cross-talk. Halnes et al. found a significantly reduced airway inflammation in asthma patients four hours after the ingestion of a meal containing soluble fiber and prebiotics compared to a placebo meal. Stable tracer studies are needed to examine the colonic production and metabolic fate of SCFAs in healthy and ill subjects.
The intestinal microbiota of older individuals is less diverse, has a higher interindividual variability, and lower SCFA production capacity compared to younger adults. Hence, a dysbiosis of the intestinal microbiota could be involved in the development of several age-related chronic systemic diseases, such as sarcopenia and lower muscle quality or cognitive dysfunction. These age-related impairments are associated with a reduced physical performance and elevated risk for falls, fractures, physical disability and mortality. Dysbiosis of the intestinal microbiota (i.e. an altered microbial composition and function) might contribute to the development of sarcopenia by modulating muscle size, composition, and function. Moreover, SCFAs, metabolites produced by beneficial bacteria, help maintaining cognitive function and psychological well-being through their anti-inflammatory and gene regulating properties. Hence, nutritional interventions, such as fiber supplementation, must be studies as a modulator of microbial composition and SCFA production rate, as well as the subsequent effects on muscle and cognitive health and overall well-being.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Healthy Participants
healthy control subjects
Fiber Inulin
Commercially available inulin is provided as powder. The following doses will be administered twice daily (with breakfast and dinner): Day 1-2: 5-g; Day 3: 7.5-g; Day 4: 10-g; Day 5: 12.5-g; Day 6-7: 15-g. All supplements are commercially available.
Placebo Maltodextrin
Commercially available maltodextrin is provided as powder. The following doses will be administered twice daily (with breakfast and dinner): Day 1-2: 5-g; Day 3: 7.5-g; Day 4: 10-g; Day 5: 12.5-g; Day 6-7: 15-g. All supplements are commercially available.
Chronic Obstructive Pulmonary Disease patients
Established diagnosis of Chronic Obstructive Pulmonary Disease
Fiber Inulin
Commercially available inulin is provided as powder. The following doses will be administered twice daily (with breakfast and dinner): Day 1-2: 5-g; Day 3: 7.5-g; Day 4: 10-g; Day 5: 12.5-g; Day 6-7: 15-g. All supplements are commercially available.
Placebo Maltodextrin
Commercially available maltodextrin is provided as powder. The following doses will be administered twice daily (with breakfast and dinner): Day 1-2: 5-g; Day 3: 7.5-g; Day 4: 10-g; Day 5: 12.5-g; Day 6-7: 15-g. All supplements are commercially available.
Healthy Young Participants
healthy young subjects with age 18-30 years old
Fiber Inulin
Commercially available inulin is provided as powder. The following doses will be administered twice daily (with breakfast and dinner): Day 1-2: 5-g; Day 3: 7.5-g; Day 4: 10-g; Day 5: 12.5-g; Day 6-7: 15-g. All supplements are commercially available.
Placebo Maltodextrin
Commercially available maltodextrin is provided as powder. The following doses will be administered twice daily (with breakfast and dinner): Day 1-2: 5-g; Day 3: 7.5-g; Day 4: 10-g; Day 5: 12.5-g; Day 6-7: 15-g. All supplements are commercially available.
Interventions
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Fiber Inulin
Commercially available inulin is provided as powder. The following doses will be administered twice daily (with breakfast and dinner): Day 1-2: 5-g; Day 3: 7.5-g; Day 4: 10-g; Day 5: 12.5-g; Day 6-7: 15-g. All supplements are commercially available.
Placebo Maltodextrin
Commercially available maltodextrin is provided as powder. The following doses will be administered twice daily (with breakfast and dinner): Day 1-2: 5-g; Day 3: 7.5-g; Day 4: 10-g; Day 5: 12.5-g; Day 6-7: 15-g. All supplements are commercially available.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Texas A&M University
OTHER
Responsible Party
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Marielle PKJ Engelen, PhD
Director
Principal Investigators
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Marielle Engelen
Role: PRINCIPAL_INVESTIGATOR
Texas A&M University - CTRAL
Locations
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Texas A&M University-CTRAL
College Station, Texas, United States
Countries
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References
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Kirschner SK, Engelen MP, Haas P, Bischoff SC, Deutz NE. Short-chain fatty acid kinetics and concentrations are higher after inulin supplementation in young and older adults: a randomized trial. Am J Clin Nutr. 2025 Jun;121(6):1224-1235. doi: 10.1016/j.ajcnut.2025.04.018. Epub 2025 Apr 22.
Other Identifiers
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2019-0832
Identifier Type: -
Identifier Source: org_study_id
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