Fiber Metabolism in Chronic Obstructive Pulmonary Disease

NCT04459156 | Completed

• 1 other identifier: 2019-0832
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Obstructive Pulmonary Disease; Aging

Keywords

fiber metabolism; short chain fatty acid production rates

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Collection up to 24 hours before study visits of weeks 1, 2, 4, and 5

Secondary Outcomes (22)

• Intestinal integrity markers by stool samples

  Weeks 1, 2, 4, and 5

• Exhalation of CO2 from short-chain fatty acid oxidation

  Weeks 1, 2, 4, and 5

• Fecal short-chain fatty acid concentrations by stool samples

  Weeks 1, 2, 4, and 5

• Body composition by DXA

  Weeks 1, 2, 4, and 5

• Bone mineral density by BIA

  Weeks 1, 2, 4, and 5

Study Arms (3)

Healthy Participants

EXPERIMENTAL

healthy control subjects

Dietary Supplement: Fiber Inulin; Dietary Supplement: Placebo Maltodextrin

Chronic Obstructive Pulmonary Disease patients

EXPERIMENTAL

Established diagnosis of Chronic Obstructive Pulmonary Disease

Dietary Supplement: Fiber Inulin; Dietary Supplement: Placebo Maltodextrin

Healthy Young Participants

EXPERIMENTAL

healthy young subjects with age 18-30 years old

Dietary Supplement: Fiber Inulin; Dietary Supplement: Placebo Maltodextrin

Interventions

Fiber Inulin DIETARY_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.

Chronic Obstructive Pulmonary Disease patients; Healthy Participants; Healthy Young Participants

Placebo Maltodextrin DIETARY_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.

Chronic Obstructive Pulmonary Disease patients; Healthy Participants; Healthy Young Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University-CTRAL

College Station, Texas, 77845, United States

Location

Related Publications (1)

• 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.

  PMID: 40274191 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marielle Engelen

  Texas A&M University - CTRAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 7, 2020
• Study Start: June 23, 2020
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2023
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)