Fiber Metabolism in Chronic Obstructive Pulmonary Disease
NCT04459156, Not applicable, Completed, Texas A&M University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Fiber Metabolism in Chronic Obstructive Pulmonary Disease | ClinicalTrials.gov |
| NCT number | NCT04459156 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 87 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Texas A&M University | ClinicalTrials.gov |
| Conditions | Chronic Obstructive Pulmonary Disease, Aging | ClinicalTrials.gov |
| Interventions | Fiber Inulin, Placebo Maltodextrin | ClinicalTrials.gov |
| First posted | 2020-07-07 | ClinicalTrials.gov |
| Last updated | 2025-09-30 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Whole body short-chain fatty acid production rates by plasma samples | 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. | ClinicalTrials.gov |
| Primary | Intestinal microbiota composition by stool sample collection using Shallow Shotgun Sequencing | 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 | ClinicalTrials.gov |
| Secondary | Intestinal integrity markers by stool samples | Weeks 1, 2, 4, and 5 | Differences and changes in fecal zonulin levels in COPD patients and healthy older and young adults. | ClinicalTrials.gov |
| Secondary | Exhalation of CO2 from short-chain fatty acid oxidation | Weeks 1, 2, 4, and 5 | Differences and changes in concentrations of exhaled, labeled CO2 originating from intravenously administered stable-isotope labeled short-chain fatty acids. | ClinicalTrials.gov |
| Secondary | Fecal short-chain fatty acid concentrations by stool samples | Weeks 1, 2, 4, and 5 | Differences and changes in fecal SCFA concentrations in COPD patients and healthy older and young adults. | ClinicalTrials.gov |
| Secondary | Body composition by DXA | Weeks 1, 2, 4, and 5 | 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. | ClinicalTrials.gov |
| Secondary | Bone mineral density by BIA | Weeks 1, 2, 4, and 5 | 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. | ClinicalTrials.gov |
| Secondary | Handgrip strength dynamometry | Weeks 1, 2, 4, and 5 | Difference and changes in handgrip strength in COPD patients and healthy older and young adults. | ClinicalTrials.gov |
| Secondary | 6 minute walk test distance | Screening visit | 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. | ClinicalTrials.gov |
| Secondary | Skeletal muscle strength of leg | Screening visit | Difference in muscle strength of leg using kin-com machine between COPD patients and healthy older and young adults. | ClinicalTrials.gov |
| Secondary | Micro-respiratory pressure meter measurement | Screening visit | Difference and changes in maximum inspiratory and expiratory pressure between COPD patients and healthy older and young adults. | ClinicalTrials.gov |
| Secondary | C-reactive protein | Weeks 1, 2, 4, and 5 | Differences and changes in the concentration of the inflammatory marker C-reactive protein in COPD patients and healthy older and young adults. | ClinicalTrials.gov |
| Secondary | Attention and executive functions measured by Trail Making Test (TMT) | Weeks 1, 2, 4, and 5 | 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. | ClinicalTrials.gov |
| Secondary | Attention and executive functions measured by Stroop Color-Word Test (SCWT) | Screening visit | 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. | ClinicalTrials.gov |
| Secondary | Gut function as reported by "The Gastrointestinal Symptom Rating Scale" | Weeks 1, 2, 4, and 5 | 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. | ClinicalTrials.gov |
| Secondary | Physical activity as reported by "Physical Activity Scale for the Elderly" | Weeks 1, 2, 4, and 5 | 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. | ClinicalTrials.gov |
| Secondary | State of mood as measured by the Hospital Anxiety and Depression Scale (HADS | Weeks 1, 2, 4, and 5 | 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. | ClinicalTrials.gov |
| Secondary | COPD Assessment Test | Weeks 1, 2, 4, and 5 | Self-administered questionnaire regarding impact of COPD on daily life | ClinicalTrials.gov |
| Secondary | 3-day diet diary | Completion within the week before study visits of weeks 1, 2, 4, and 5 | 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. | ClinicalTrials.gov |
| Secondary | Group differences in learning and memory as measured by Digit Span | Weeks 1, 2, 4, and 5 | Recall of numbers in the same order (Digit Forward) and in reverse order (Digit Backward). Measures auditory attention and verbal working memory. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 40274191 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)