Fish Oil and HMB Supplementation in COPD

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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 whether adding either HMB at 3.0 g/d to the low dose of EPA+DHA (2.0 g/d) will enhance these effects even more.

Key facts

Study ID

NCT03796455

Run by

Texas A&M University

People needed

54

Starts

2018-04-25

Expected to finish

2020-04-01

Last updated by the study team

2022-02-07

Who can join

Age: 45 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Texas A&M University-CTRAL — College Station, Texas, United States

Full record on ClinicalTrials.gov

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