Chronic Obstructive Pulmonary DiseaseNCT04459156
Fiber Metabolism in Chronic Obstructive Pulmonary Disease
A study testing Fiber Inulin in people with Chronic Obstructive Pulmonary Disease and Aging, run by Texas A&M University at 1 site in United States.
Trial 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 inulin vs. placebo intake in COPD patients to healthy matched controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Aging
- What is being tested?
- Fiber Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2020to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M University-CTRAL
College Station, Texas, 77845
About this study
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 inulin vs. placebo intake in COPD patients to healthy matched controls. This protocol is an extension of a recent study about whole-body SCFA production rates in COPD patients. The investigators hypothesize that a short-term fiber supplementation increases SCFA production in COPD patients.
Read the 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 recommends a daily fiber uptake of 25 g. However, in 2009-2010 the mean fiber intake of US adults was 17 g/day. Fiber cannot be digested by human enzymes and reach the colon undigested. Depending on the chemical structure (solubility, degree of polymerization) of the fiber, it can or cannot be fermented by the intestinal bacteria. Insoluble, unfermented fibers such as cellulose help to prevent constipation by enhancing bowel movement and the transit time of the feces. Most soluble fibers like inulin can be fermented by intestinal bacteria. During the bacterial fermentation short-chain fatty acids (SCFA) such as acetate (C2), propionate (C3), and butyrate (C4) are produced. The production is highest in the proximal colon where the abundance of fiber is the highest. The colonocytes absorb more than 90 % of the SCFAs, the rest is excreted with the feces. Most of the butyrate is oxidized in the colonocytes, being their main energy source. Propionate gets metabolized by the liver. In particular acetate enters the systemic circulation and might have anti-inflammatory and immune modulating effects. Indole and isovalerate are products of bacterial amino acid fermentation. Indole is solely produced by bacterial enzymes from the essential amino acid tryptophan (TRP) and isovalerate from branched-chain amino acids.
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
- Chronic Obstructive Pulmonary Disease, Aging
- Being tested
- Fiber Inulin, Placebo Maltodextrin
- Keywords
- fiber metabolism, short chain fatty acid production rates
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber InulinDietary supplement
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 MaltodextrinDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | healthy control subjects Receives: Dietary Supplement: Fiber Inulin; Dietary Supplement: Placebo Maltodextrin |
| Chronic Obstructive Pulmonary Disease patients | Experimental | Established diagnosis of Chronic Obstructive Pulmonary Disease Receives: Dietary Supplement: Fiber Inulin; Dietary Supplement: Placebo Maltodextrin |
| Healthy Young Participants | Experimental | healthy young subjects with age 18-30 years old Receives: Dietary Supplement: Fiber Inulin; Dietary Supplement: Placebo Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body short-chain fatty acid production rates by plasma samples
Differences and changes in whole body SCFA production rates in COPD patients and healthy older and young adults after administration of stable-isotope labeled short-chain fatty acids.
Measured: Weeks 1, 2, 4, and 5
Intestinal microbiota composition by stool sample collection using Shallow Shotgun Sequencing
Differences and changes in intestinal microbiota composition in COPD patients and healthy older and young adults using Shallow Shotgun Sequencing
Measured: Collection up to 24 hours before study visits of weeks 1, 2, 4, and 5
Secondary outcomes (22)
Intestinal integrity markers by stool samples
Differences and changes in fecal zonulin levels in COPD patients and healthy older and young adults.
Measured: Weeks 1, 2, 4, and 5
Exhalation of CO2 from short-chain fatty acid oxidation
Differences and changes in concentrations of exhaled, labeled CO2 originating from intravenously administered stable-isotope labeled short-chain fatty acids.
Measured: Weeks 1, 2, 4, and 5
Fecal short-chain fatty acid concentrations by stool samples
Differences and changes in fecal SCFA concentrations in COPD patients and healthy older and young adults.
Measured: Weeks 1, 2, 4, and 5
Body composition by DXA
Differences in muscle mass (kg), fat mass (kg), and bone mineral density (g/cm^2) between COPD patients and healthy older and young adults using DXA.
Measured: Weeks 1, 2, 4, and 5
Bone mineral density by BIA
Differences in muscle mass (kg), fat mass (kg), and extra- and intracellular fluid (L) between COPD patients and healthy older and young adults using BIA.
Measured: Weeks 1, 2, 4, and 5
Handgrip strength dynamometry
Difference and changes in handgrip strength in COPD patients and healthy older and young adults.
Measured: Weeks 1, 2, 4, and 5
6 minute walk test distance
With this sub-maximal exercise test, aerobic capacity and endurance will be compared between COPD patients and healthy older and young adults. The outcome is the distance covered over a time of 6 minutes.
Measured: Screening visit
Skeletal muscle strength of leg
Difference in muscle strength of leg using kin-com machine between COPD patients and healthy older and young adults.
Measured: Screening visit
Micro-respiratory pressure meter measurement
Difference and changes in maximum inspiratory and expiratory pressure between COPD patients and healthy older and young adults.
Measured: Screening visit
C-reactive protein
Differences and changes in the concentration of the inflammatory marker C-reactive protein in COPD patients and healthy older and young adults.
Measured: Weeks 1, 2, 4, and 5
Attention and executive functions measured by Trail Making Test (TMT)
In Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy. In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility. The total time in seconds will be recorded for each measure.
Measured: Weeks 1, 2, 4, and 5
Attention and executive functions measured by Stroop Color-Word Test (SCWT)
A word page with words printed in black ink, a color page with blocks printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The total time in seconds was reported for each trial.
Measured: Screening visit
Gut function as reported by "The Gastrointestinal Symptom Rating Scale"
Self-administered questionnaire regarding gut function and associated symptoms. It is composed of 15 items (7-Point Likert Scale) assessing Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. Scores range from 15 to 105 with a higher score indicating more discomfort.
Measured: Weeks 1, 2, 4, and 5
Physical activity as reported by "Physical Activity Scale for the Elderly"
Self-administered questionnaire is intended for use in an elderly population and focuses on 3 types of activities: leisure time activities, household activities and work-related activities.
Measured: Weeks 1, 2, 4, and 5
State of mood as measured by the Hospital Anxiety and Depression Scale (HADS
A fourteen item self-assessment scale. Seven of the items related to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression.
Measured: Weeks 1, 2, 4, and 5
COPD Assessment Test
Self-administered questionnaire regarding impact of COPD on daily life
Measured: Weeks 1, 2, 4, and 5
3-day diet diary
The subject is asked to note in detail all the food and drinks consumed during 3 days (2 week days and 1 weekend day) in the week prior to each test day.
Measured: Completion within the week before study visits of weeks 1, 2, 4, and 5
Group differences in learning and memory as measured by Digit Span
Recall of numbers in the same order (Digit Forward) and in reverse order (Digit Backward). Measures auditory attention and verbal working memory.
Measured: Weeks 1, 2, 4, and 5
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
Assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning.
Measured: Screening visit
Group differences in state of mood as measured by the Profile of Mood State (POMS)
A psychological distress scale to measure mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.
Measured: Weeks 1, 2, 4, and 5
Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)
The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonemic verbal fluency. The raw score (total and mean words recorded across the three trials) will be reported.
Measured: Weeks 1, 2, and 5
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Quality of life concerns related to fatigue will be assessed only in COPD patients with this questionnaire.
Measured: Weeks 1, 2, 4, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start23 Jun 2020
- Primary completion10 Mar 2022
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle Engelen, Principal investigator, Texas A&M University - CTRAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459156
- Sponsor's protocol ID
- 2019-0832
- Status last verified
- Sep 2025
- First submitted
- 22 Jun 2020
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40274191
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiber Metabolism in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04459156
- Acronym / sponsor ID
- 2019-0832
- Conditions
- Chronic Obstructive Pulmonary Disease, Aging
- Keywords
- fiber metabolism, short chain fatty acid production rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 inulin vs. placebo intake in COPD patients to healthy matched controls. This protocol is an extension of a recent study about whole-body SCFA production rates in COPD patients. The investigators hypothesize that a short-term fiber supplementation increases SCFA production in COPD patients.
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 recommends a daily fiber uptake of 25 g. However, in 2009-2010 the mean fiber intake of US adults was 17 g/day. Fiber cannot be digested by human enzymes and reach the colon undigested. Depending on the chemical structure (solubility, degree of polymerization) of the fiber, it can or cannot be fermented by the intestinal bacteria. Insoluble, unfermented fibers such as cellulose help to prevent constipation by enhancing bowel movement and the transit time of the feces. Most soluble fibers like inulin can be fermented by intestinal bacteria. During the bacterial fermentation short-chain fatty acids (SCFA) such as acetate (C2), propionate (C3), and butyrate (C4) are produced. The production is highest in the proximal colon where the abundance of fiber is the highest. The colonocytes absorb more than 90 % of the SCFAs, the rest is excreted with the feces. Most of the butyrate is oxidized in the colonocytes, being their main energy source. Propionate gets metabolized by the liver. In particular acetate enters the systemic circulation and might have anti-inflammatory and immune modulating effects. Indole and isovalerate are products of bacterial amino acid fermentation. Indole is solely produced by bacterial enzymes from the essential amino acid tryptophan (TRP) and isovalerate from branched-chain amino acids.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Dietary Supplement: Fiber Inulin, Dietary Supplement: Placebo Maltodextrinhealthy control subjects |
| Chronic Obstructive Pulmonary Disease patients | Experimental | Dietary Supplement: Fiber Inulin, Dietary Supplement: Placebo MaltodextrinEstablished diagnosis of Chronic Obstructive Pulmonary Disease |
| Healthy Young Participants | Experimental | Dietary Supplement: Fiber Inulin, Dietary Supplement: Placebo Maltodextrinhealthy young subjects with age 18-30 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiber InulinCommercially 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. | Dietary supplement | Chronic Obstructive Pulmonary Disease patients, Healthy Participants, Healthy Young Participants |
| Placebo MaltodextrinCommercially 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. | Dietary supplement | Chronic Obstructive Pulmonary Disease patients, Healthy Participants, Healthy Young Participants |
Primary outcome
Whole body short-chain fatty acid production rates by plasma samples
Time frame: Weeks 1, 2, 4, and 5
Differences and changes in whole body SCFA production rates in COPD patients and healthy older and young adults after administration of stable-isotope labeled short-chain fatty acids.
Intestinal microbiota composition by stool sample collection using Shallow Shotgun Sequencing
Time frame: Collection up to 24 hours before study visits of weeks 1, 2, 4, and 5
Differences and changes in intestinal microbiota composition in COPD patients and healthy older and young adults using Shallow Shotgun Sequencing
22 secondary outcomes
Intestinal integrity markers by stool samples
Time frame: Weeks 1, 2, 4, and 5
Exhalation of CO2 from short-chain fatty acid oxidation
Time frame: Weeks 1, 2, 4, and 5
Fecal short-chain fatty acid concentrations by stool samples
Time frame: Weeks 1, 2, 4, and 5
Body composition by DXA
Time frame: Weeks 1, 2, 4, and 5
Bone mineral density by BIA
Time frame: Weeks 1, 2, 4, and 5
Handgrip strength dynamometry
Time frame: Weeks 1, 2, 4, and 5
6 minute walk test distance
Time frame: Screening visit
Skeletal muscle strength of leg
Time frame: Screening visit
Micro-respiratory pressure meter measurement
Time frame: Screening visit
C-reactive protein
Time frame: Weeks 1, 2, 4, and 5
Attention and executive functions measured by Trail Making Test (TMT)
Time frame: Weeks 1, 2, 4, and 5
Attention and executive functions measured by Stroop Color-Word Test (SCWT)
Time frame: Screening visit
Gut function as reported by "The Gastrointestinal Symptom Rating Scale"
Time frame: Weeks 1, 2, 4, and 5
Physical activity as reported by "Physical Activity Scale for the Elderly"
Time frame: Weeks 1, 2, 4, and 5
State of mood as measured by the Hospital Anxiety and Depression Scale (HADS
Time frame: Weeks 1, 2, 4, and 5
COPD Assessment Test
Time frame: Weeks 1, 2, 4, and 5
3-day diet diary
Time frame: Completion within the week before study visits of weeks 1, 2, 4, and 5
Group differences in learning and memory as measured by Digit Span
Time frame: Weeks 1, 2, 4, and 5
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
Time frame: Screening visit
Group differences in state of mood as measured by the Profile of Mood State (POMS)
Time frame: Weeks 1, 2, 4, and 5
Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)
Time frame: Weeks 1, 2, and 5
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: Weeks 1, 2, 4, and 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 40274191Kirschner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielle Engelen principal investigator
Texas A&M University - CTRAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber Inulin in people with Chronic Obstructive Pulmonary Disease and Aging, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body short-chain fatty acid production rates by plasma samples (time frame: Weeks 1, 2, 4, and 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04459156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.