AECOPD and Nutritional Supplementation in COPD

NCT06801964 | Completed

• 1 other identifier: 2014-0139
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Better understanding of the duration needed to overcome metabolic disturbances in patients experiencing exacerbation. Also, the explore role of nutritional intervention in the treatment program of stable COPD patients and in those recovering from an acute exacerbation (AECOPD) is important to restore loss of muscle mass and function and to reduce readmission and hospitalization rate of these patients, thereby leading to improved clinical and overall outcome as well as reduction of health care costs.

Conditions

Obstructive Pulmonary Disease; Exacerbation Copd

Outcome Measures

Primary Outcomes (1)

• Change in net whole-body protein synthesis

  Change in whole-body protein synthesis rate

  2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes

Study Arms (4)

AECOPD - No Nutrition

EXPERIMENTAL

Other: Stable isotope infusion

AECOPD - Nutrition

EXPERIMENTAL

Other: Stable isotope infusion; Dietary Supplement: Protein and Fish Oil; Dietary Supplement: Protein and Olive Oil; Dietary Supplement: Carbohydrate and Olive Oil

stable COPD

EXPERIMENTAL

Other: Stable isotope infusion; Dietary Supplement: Protein and Fish Oil; Dietary Supplement: Protein and Olive Oil; Dietary Supplement: Carbohydrate and Olive Oil

Healthy

OTHER

Other: Stable isotope infusion

Interventions

Stable isotope infusion OTHER

such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

AECOPD - No Nutrition; AECOPD - Nutrition; Healthy; stable COPD

Protein and Fish Oil DIETARY_SUPPLEMENT

milk/carbohydrate mixture and supplementation of 3.5g of EPA+DHA (7g of fish oil)

AECOPD - Nutrition; stable COPD

Protein and Olive Oil DIETARY_SUPPLEMENT

milk/carbohydrate mixture with olive oil

AECOPD - Nutrition; stable COPD

Carbohydrate and Olive Oil DIETARY_SUPPLEMENT

carbohydrate mixture with olive oil

AECOPD - Nutrition; stable COPD

Eligibility Criteria

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

You may qualify if:

• Between age 45 and older
• Experiencing an acute exacerbation of COPD (defined as a combination of symptoms such as 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 years) and admitted at College Station Medical Center (with expected stay less than 10 days) or staying at home.
• Willingness and ability to comply with the protocol, including:
• Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit
• Ability to lie in supine or elevated position for 4 hours
• Ability to walk, sit down and stand up independently
• Between age 45 and older
• 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 at least 4 weeks prior to the first test day
• Shortness of breath on exertion
• Willingness and ability to comply with the protocol, including:
• Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit
• Ability to lie in supine or elevated position for 4 hours
• Healthy male or female according to the investigator's or appointed staff's judgment
• Ability to walk, sit down and stand up independently

You may not qualify if:

• Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only)
• Established diagnosis of malignancy
• History of untreated metabolic diseases including hepatic or renal disorder
• Presence of other acute metabolic illnesses (ie renal, liver disease)
• 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
• Dietary or lifestyle characteristics:
• Current alcohol or drug abuse
• Known hypersensitivity to fish and/or shellfish, Swanson EFAs Super EPA Fish oil or any of its ingredients, Swanson EFAs Certified Organic Extra Virgin Olive oil or any of its ingredients or Smartfish Nutrifriend or any of its ingredients (AECOPD and stable COPD nutrition groups only)
• Use of supplements containing more than 1 g of EPA+DHA 3 months prior to the first test day (AECOPD and stable COPD nutrition groups only)
• 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
• Body mass index \<18.5 or \>45 kg/m2

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

MeSH Terms

Conditions

Lung Diseases, Obstructive

Interventions

Proteins; Fish Oils; Olive Oil; Carbohydrates

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Marielle Engelen

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: October 20, 2017
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)