Status:
COMPLETED
Fish Oil and HMB Supplementation in COPD
Lead Sponsor:
Texas A&M University
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
45-100 years
Phase:
NA
Brief Summary
In the present study, the role of chronic (10 weeks) intake of low dose (2g/day) of EPA+DHA in whole body protein metabolism, and functional performance and systemic inflammation will be examined, and...
Detailed Description
Weight loss commonly occurs in patients with Chronic Obstructive Pulmonary Disease (COPD), negatively influencing their quality of life, treatment response and survival. Furthermore, limb muscle dysfu...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Ability to walk, sit down and stand up independently
- Ability to lie in supine or slightly elevated position for 8.5 hours
- Age 45 - 100
- Clinical diagnosis of COPD, including moderate to very severe chronic airflow limitation, and an FEV1 \< 70% of reference FEV1 (GOLD II-III). If subjects are on β2 agonists, only those subjects with \<10% improvement in FEV1 will be included.
- Clinically stable condition and not suffering from a 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 first test day
- Shortness of breath on exertion
- Willingness and ability to comply with the protocol, including:
- Refraining from intense physical activities (72h) prior to each study visit
- Adhering to fasting state and no smoking from 10 pm ± 2h onwards the day prior to each study visit
- Exclusion Criteria
- Participants 86 and older that fail to get physician approval
- Established diagnosis of malignancy
- Established diagnosis of Insulin Dependent 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 nurse that was found during the screening visit, that would interfere with the study or safety of the patient
- BMI ≥ 45 kg/m2
- Dietary or lifestyle characteristics:
- Daily use of supplements containing EPA+DHA or HMB prior to the first test day
- Use of protein or amino acid containing nutritional supplements within 5 days of first test day
- Indications related to interaction with study products. Known hypersensitivity to fish and/or shellfish and/or soy
- Use of long-term oral corticosteroids or short course of oral corticosteroids 4 weeks preceding first test day
- Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Exclusion
Key Trial Info
Start Date :
April 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03796455
Start Date
April 25 2018
End Date
April 1 2020
Last Update
February 7 2022
Active Locations (1)
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1
Texas A&M University-CTRAL
College Station, Texas, United States, 77843