AECOPD and Nutritional Supplementation in COPD

Not Applicable

Completed

• Conditions: Obstructive Pulmonary Disease; Exacerbation Copd

• Registration Number: NCT06801964
• Lead Sponsor: Texas A&M University

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.

Detailed Description

Based on the literature, the Investigators hypothesize that an AECOPD is associated with an acute inflammatory response, accelerated muscle protein loss and compromised NO production and glutathione synthesis as compared to a stable COPD and healthy control group. Two weeks after AECOPD these disturbances are only partially restored and therefore nutritional intervention is required. Supplementation with milk proteins (containing essential amino acids) / carbohydrate (CHO) mixture in combination with fish oil supplementation will reduce the metabolic alterations in COPD patients recovering from an acute exacerbation but also in stable COPD as chronic systemic inflammation is also present in these patients. By simultaneously attenuating the catabolic effects of inflammation by fish oil and increasing the anabolic stimulus by high quality protein intake, muscle mass and function, will be restored, leading to better physical performance, condition and quality of life in COPD.

Specific aims:

* Specific aim 1: To test the hypothesis that AECOPD in outpatients results in severe net protein catabolism, impaired NO synthesis and GSH synthesis as compared to stable COPD. These disturbances are associated with impaired nutritional and functional status, and quality of life in COPD.

* Specific aim 2: To test the hypothesis that 14 days after AECOPD these disturbances are partially restored but still not comparable to that in stable chronic COPD patients and healthy control subjects. One group of participants with AECOPD will also be tested 10 weeks after exacerbation to see if metabolic disturbances have been restored.

* Specific aim 3: To test the effects of 8 weeks of nutritional supplementation with high-quality milk proteins (containing essential amino acids)/ carbohydrate (CHO) mixture with or without fish oil supplementation on protein and amino acid metabolism, muscle mass, muscle and cognitive function, physical performance, quality of life, and clinical and overall outcome in stable COPD patients and in those recovering from AECOPD.

Study Timeline

• Study Start: 2017-10-20
• Primary Completion: 2019-01-08
• Study Completion: 2019-01-08
• Status Verified: 2025-01
• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in net whole-body protein synthesis	2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes	Change in whole-body protein synthesis rate

Trial Locations

Locations (1)

Texas A&M University; 🇺🇸 College Station, Texas, United States