Obstructive Pulmonary DiseaseNCT06801964
AECOPD and Nutritional Supplementation in COPD
A study testing Stable isotope infusion, Protein and Fish Oil and Protein and Olive Oil in people with Obstructive Pulmonary Disease and Exacerbation Copd, run by Texas A&M University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Pulmonary Disease, Exacerbation Copd
- What is being tested?
- Stable isotope infusion, Protein and Fish Oil and Protein and Olive Oil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2017to 8 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Between age 45 and older
- No diagnosis of chronic airflow limitation
- 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
Who cannot join
- 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:
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- 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
- When during the period from enrollment to completion of the study any condition is developed, whether causing a subject to not meet any of the inclusion criteria or to meet one or more of the exclusion criteria, the study can either be temporarily or permanently stopped for that subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Supplementation in Patient With Stable COPD and in Those Recovering From an Acute Exacerbation of COPD: the Effects on Metabolism and Clinical Status
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.
Read the 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
- Being tested
- Stable isotope infusion, Protein and Fish Oil, Protein and Olive Oil, Carbohydrate and Olive Oil
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable isotope infusionOther
such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
Protein and Fish OilDietary supplement
milk/carbohydrate mixture and supplementation of 3.5g of EPA+DHA (7g of fish oil)
Protein and Olive OilDietary supplement
milk/carbohydrate mixture with olive oil
Carbohydrate and Olive OilDietary supplement
carbohydrate mixture with olive oil
| Study group | Role | What they receive |
|---|---|---|
| AECOPD - No Nutrition | Experimental | Not described Receives: Other: Stable isotope infusion |
| AECOPD - Nutrition | Experimental | Not described Receives: 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 | Not described Receives: Other: Stable isotope infusion; Dietary Supplement: Protein and Fish Oil; Dietary Supplement: Protein and Olive Oil; Dietary Supplement: Carbohydrate and Olive Oil |
| Healthy | Other | Not described Receives: Other: Stable isotope infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in net whole-body protein synthesis
Change in whole-body protein synthesis rate
Measured: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start20 Oct 2017
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle Engelen, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801964
- Sponsor's protocol ID
- 2014-0139
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
PubMed 42149813
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Supplementation in Patient With Stable COPD and in Those Recovering From an Acute Exacerbation of COPD: the Effects on Metabolism and Clinical Status
- ClinicalTrials.gov ID
- NCT06801964
- Acronym / sponsor ID
- 2014-0139
- Conditions
- Obstructive Pulmonary Disease, Exacerbation Copd
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stable isotope infusionsuch as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline | Other | AECOPD - No Nutrition, AECOPD - Nutrition, Healthy, stable COPD |
| Protein and Fish Oilmilk/carbohydrate mixture and supplementation of 3.5g of EPA+DHA (7g of fish oil) | Dietary supplement | AECOPD - Nutrition, stable COPD |
| Protein and Olive Oilmilk/carbohydrate mixture with olive oil | Dietary supplement | AECOPD - Nutrition, stable COPD |
| Carbohydrate and Olive Oilcarbohydrate mixture with olive oil | Dietary supplement | AECOPD - Nutrition, stable COPD |
Primary outcome
Change in net whole-body protein synthesis
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Derived from this study: PubMed 42149813Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielle Engelen principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stable isotope infusion, Protein and Fish Oil and Protein and Olive Oil in people with Obstructive Pulmonary Disease and Exacerbation Copd, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in net whole-body protein synthesis (time frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06801964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.