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Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in Chronic Obstructive Pulmonary Disease (COPD): Aim 2


N/A
45 Years
N/A
Open (Enrolling)
Both
Chronic Obstructive Pulmonary Disease, Muscle Wasting

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Trial Information

Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in Chronic Obstructive Pulmonary Disease (COPD): Aim 2


Specific aim 1: To test the hypothesis that supplementation of 3.5g EPA+DHA will increase
the acute net fractional muscle protein synthesis more in COPD patients as compared to
healthy controls in response to a high quality protein supplement.

Specific aim 2: To test the hypothesis that 3.5g/day EPA+DHA for 4 consecutive weeks induces
a higher increase in net fractional muscle protein synthesis in response to a high quality
protein supplement as compared to 2g/day EPA+DHA in COPD patients.

Therefore, to answer the specific aims in this study only the COPD subjects will undergo a
4-week intervention period.


Inclusion Criteria:



Inclusion criteria COPD subjects:

- Ability to walk, sit down and stand up independently

- Age 45 years or older

- Ability to lay in supine or elevated position for 8 hours

- Diagnosis of moderate to severe chronic airflow limitation, defined as measured
forced expiratory volume in one second (FEV1) ≤ 70% of referen¬ce FEV1

- Clinically stable condition and not suffering from 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 study

- Shortness of breath on exertion

- Willingness and ability to comply with the protocol, including:

- Refraining from alcohol consumption (24 h) and intense physical activities (72h)
prior to each study visit

- Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study
visit

Inclusion criteria healthy control subjects:

- 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 or older

- Ability to lay in supine or elevated position for 8 hours

- No diagnosis of COPD and forced expiratory volume in one second (FEV1) > 80% of
referen¬ce FEV1

- Willingness and ability to comply with the protocol, including:

- Refraining from alcohol consumption (24 h) and intense physical activities (72h)
prior to each study visit

- Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study
visit

Exclusion Criteria:

- 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

- Established diagnosis of Diabetes Mellitus

- History of untreated metabolic diseases including hepatic or renal disorder

- Presence of acute illness or metabolically unstable chronic illness

- Recent myocardial infarction (less than 1 year)

- Any other condition according to the PI or study physicians would interfere with
proper conduct of the study / safety of the patient

- BMI ≥ 40 kg/m2

- Dietary or lifestyle characteristics:

- Use of supplements containing EPA+DHA 3 months prior to the first test day Use
of protein or amino acid containing nutritional supplements within 5 days of
first study day

- Current alcohol or drug abuse

- Indications related to interaction with study products:

- Known allergy to milk or milk products

- 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

- Contraindications to biopsy procedure:

- Platelet count (PLT) < 100,000

- History of hypo- or hyper-coagulation disorders including use of a Coumadin
derivative, history of deep venous thrombosis (DVT), or pulmonary embolism (PE)
at any point in lifetime

- Currently taking anti-thrombotics and cannot stop for 7 days (i.e. medical
indication)

- Allergy to local anesthetic

- Use of long-term oral corticosteroids or short course of oral corticosteroids in the
preceding month before enrollment

- Failure to give informed consent or Investigator's uncertainty about the willingness
or ability of the subject to comply with the protocol requirements

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Outcome Measure:

Fractional muscle protein synthesis and breakdown rate (FSR and FBR) of mixed muscle protein (%/h) and net fractional muscle protein synthesis (nFSR = FSR - FBR)

Outcome Description:

On the study days the primary outcome measure is determined acutely before and after 4 hours of feeding and after intake of either the 3.5 g EPA+DHA, a placebo or 2.0 g EPA+DHA (last category only applicable to COPD group). After study day 1 COPD patients undergo a 4-week intervention period of daily EPA+DHA or placebo supplementation and on their return visit (2nd study day) the primary outcome measure is determined again.

Outcome Time Frame:

Acutely before and after 4 hours of feeding and the change after 4 weeks of EPA+DHA or placebo supplementation

Safety Issue:

No

Principal Investigator

Marielle Engelen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Texas A&M University

Authority:

United States: Institutional Review Board

Study ID:

2012-0171

NCT ID:

NCT01624792

Start Date:

June 2012

Completion Date:

December 2014

Related Keywords:

  • Chronic Obstructive Pulmonary Disease
  • Muscle Wasting
  • Protein metabolism
  • casein protein
  • EPA
  • Fish oil
  • Lung Diseases
  • Respiration Disorders
  • Pulmonary Disease, Chronic Obstructive
  • Muscular Atrophy
  • Lung Diseases, Obstructive

Name

Location

Texas A&M UniversityCollege Station, Texas  77843