NCT06801964

AECOPD and Nutritional Supplementation in COPD

Nutritional Supplementation in Patient With Stable COPD and in Those Recovering From an Acute Exacerbation of COPD: the Effects on Metabolism and Clinical Status

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Texas A&M University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obstructive Pulmonary Disease
• Exacerbation Copd

Interventions

Type	Name	Description
OTHER	Stable isotope infusion	such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
DIETARY_SUPPLEMENT	Protein and Fish Oil	milk/carbohydrate mixture and supplementation of 3.5g of EPA+DHA (7g of fish oil)
DIETARY_SUPPLEMENT	Protein and Olive Oil	milk/carbohydrate mixture with olive oil
DIETARY_SUPPLEMENT	Carbohydrate and Olive Oil	carbohydrate mixture with olive oil

Timeline

• Start date: 2017-10-20
• Primary completion: 2019-01-08
• Completion: 2019-01-08
• First posted: 2025-01-30
• Last updated: 2025-01-30

Locations

1 site across 1 country: United States