Short Chain Fatty Acid Metabolism in COPD

NCT03327181 | Completed

• 1 other identifier: 2017-0112
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The short chain fatty acid (SCFA) metabolism has not been studied in subjects suffering from COPD. The purpose of this study is to compare the SCFA metabolism in COPD patients to healthy matched controls. This protocol is an extension of recent studies about protein digestion and absorption abnormalities in COPD patients. The investigators hypothesize that SCFA production might be lower in COPD patients than in healthy subjects.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

short chain fatty acid metabolism

Outcome Measures

Primary Outcomes (1)

• whole body short-chain fatty acid metabolism

  change in whole body scfa metabolism

  -10, 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50, 60 min

Secondary Outcomes (12)

• Fat free mass measured using dual-energy x-ray absorptiometry

  1 day

• Fat mass measured using dual-energy x-ray absorptiometry

  1 day

• Bone density measured using dual-energy x-ray absorptiometry

  1 day

• handgrip strength dynamometry

  1 day

• Micro-respiratory pressure meter measurement

  1 day

Study Arms (2)

COPD

EXPERIMENTAL

The subject will arrive fasted. A catheter will be inserted in the arm for stable tracer SCFA infusion and blood sampling. The hand of the arm used for blood sampling will be placed in a thermostatically controlled warmed box that heats the air. Immediately after a baseline blood sample is taken, an infusion with stable tracers will be administered by the research nurse. Stable tracers are given to measure SCFA metabolism. Blood samples will be collected before and/or after infusion. Subjects will be asked to complete a list of questions regarding quality of life, mood and depression, diet, and a variety of functional measurements.

Dietary Supplement: short chain fatty acid tracers

Healthy older adults

ACTIVE COMPARATOR

The subject will arrive fasted. A catheter will be inserted in the arm for stable tracer SCFA infusion and blood sampling. The hand of the arm used for blood sampling will be placed in a thermostatically controlled warmed box that heats the air. Immediately after a baseline blood sample is taken, an infusion with stable tracers will be administered by the research nurse. Stable tracers are given to measure SCFA metabolism. Blood samples will be collected before and/or after infusion. Subjects will be asked to complete a list of questions regarding quality of life, mood and depression, diet, and a variety of functional measurements.

Dietary Supplement: short chain fatty acid tracers

Interventions

short chain fatty acid tracers DIETARY_SUPPLEMENT

stable tracer infusion of acetate, propionate, and butyrate

COPD; Healthy older adults

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to walk, sit down and stand up independently
• Age 45 years - 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
• 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 years - 100 years
• Ability to lay in supine or elevated position for 1.5 hours
• No diagnosis of COPD
• 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)
• Subjects 86 years and older that fail to get physician eligibility confirmation
• 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
• 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
• Use of protein or amino acid containing nutritional supplements within 5 days of first study day
• Use of short course of oral corticosteroids within 4 weeks preceding first study day
• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843-4253, United States

Location

Related Publications (1)

• Engelen MPKJ, Kirschner SK, Coyle KS, Argyelan D, Neal G, Dasarathy S, Deutz NEP. Sex related differences in muscle health and metabolism in chronic obstructive pulmonary disease. Clin Nutr. 2023 Sep;42(9):1737-1746. doi: 10.1016/j.clnu.2023.06.031. Epub 2023 Jul 26.

  PMID: 37542951 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, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 31, 2017
• Study Start: April 19, 2017
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)