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Fish Oil and HMB Supplementation in COPD (COPD fish oil)

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ClinicalTrials.gov Identifier: NCT03796455
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University

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 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Dietary Supplement: Capsule + Powder supplementation Other: stable tracer infusion Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Low Dose of Fish Oil (EPA+DHA) vs. Combined EPA+DHA and HMB Supplementation on Protein Metabolism, Muscle Mass and Functional Capacity in Moderate to Severe COPD
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: Fish Oil
2.0 g EPA + DHA / day + placebo powder
Dietary Supplement: Capsule + Powder supplementation
For Fish oil and Placebo oil, treatment will be provided in capsules.Each group will receive dose distributed to 3 capsules per day. Participants will be instructed to take all capsules with morning meal. . For HMB and a placebo powder, product will be delivered as powder taken with water or non-carbonated beverage (like juice). Product will be provided in 2 sachets/day. One sachet should be consumed with breakfast and the other prior to bedtime (approx. 10pm).

Other: stable tracer infusion
labeled amino acids L-Phenylalanine (ring-13C6), L-Tyrosine (ring-D4), and tau-Methylhistidine will be infused as a single injection. Subsequently, the catheter will be used for arterialized venous blood samples (3 ml) drawn multiple through the day

Experimental: Fish Oil and HMB
2.0 g EPA + DHA + 3.0 g HMB / day
Dietary Supplement: Capsule + Powder supplementation
For Fish oil and Placebo oil, treatment will be provided in capsules.Each group will receive dose distributed to 3 capsules per day. Participants will be instructed to take all capsules with morning meal. . For HMB and a placebo powder, product will be delivered as powder taken with water or non-carbonated beverage (like juice). Product will be provided in 2 sachets/day. One sachet should be consumed with breakfast and the other prior to bedtime (approx. 10pm).

Other: stable tracer infusion
labeled amino acids L-Phenylalanine (ring-13C6), L-Tyrosine (ring-D4), and tau-Methylhistidine will be infused as a single injection. Subsequently, the catheter will be used for arterialized venous blood samples (3 ml) drawn multiple through the day

Placebo Comparator: Placebo
3 g/d soy oil: corn oil (50:50 ratio) + placebo powder
Dietary Supplement: Capsule + Powder supplementation
For Fish oil and Placebo oil, treatment will be provided in capsules.Each group will receive dose distributed to 3 capsules per day. Participants will be instructed to take all capsules with morning meal. . For HMB and a placebo powder, product will be delivered as powder taken with water or non-carbonated beverage (like juice). Product will be provided in 2 sachets/day. One sachet should be consumed with breakfast and the other prior to bedtime (approx. 10pm).

Other: stable tracer infusion
labeled amino acids L-Phenylalanine (ring-13C6), L-Tyrosine (ring-D4), and tau-Methylhistidine will be infused as a single injection. Subsequently, the catheter will be used for arterialized venous blood samples (3 ml) drawn multiple through the day




Primary Outcome Measures :
  1. Changes to net whole body protein metabolism [ Time Frame: baseline and after 10-week supplementation ]
    whole body protein synthesis and myofibrillar protein breakdown measured by labeled amino acids on each study day via blood drawn at time 4, 10, 15, 20, 30, 40, 60, 120, 180, 240 minutes of infusion


Secondary Outcome Measures :
  1. muscle mass [ Time Frame: 15 minutes on baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation ]
    Body composition as measured by Dual-Energy X-ray Absorptiometry

  2. limb muscle strength [ Time Frame: 15 minutes on baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation ]
    kin-com 1-leg test

  3. respiratory muscle strength [ Time Frame: 15 minutes on baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation ]
    Micro-respiratory pressure meter to measure maximum inspiratory and expiratory pressure

  4. functional performance via six minute walk test [ Time Frame: baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation ]
    walk a predetermined loop of 69.77 meters (228.89 feet) at self-selected pace for six minutes

  5. systemic inflammatory markers [ Time Frame: baseline visit and after 10-week supplementation ]
    blood sample will be taken to measure c-reactive protein levels

  6. resting energy expenditure [ Time Frame: baseline visit and after 10-week supplementation ]
    Oxygen consumption and carbon dioxide production will be calculated from the airflow in a transparent plastic (Plexiglas) hood to determine concentration differences between inhaled and exhaled air



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Ages Eligible for Study:   45 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796455


Contacts
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Contact: Marielle Engelen 9792202282 mpkj.engelen@ctral.org
Contact: Laura Ruebush 9792185515 le.ruebush@ctral.org

Locations
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United States, Texas
Texas A&M University-CTRAL Recruiting
College Station, Texas, United States, 77843
Contact: Marielle Engelen, PhD    979-220-2282    mpkj.engelen@ctral.org   
Contact: Laura Ruebush, PhD    9792185515    le.ruebush@ctral.org   
Sponsors and Collaborators
Texas A&M University

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Responsible Party: Marielle PKJ Engelen, PhD, Associate Professor, Texas A&M University
ClinicalTrials.gov Identifier: NCT03796455     History of Changes
Other Study ID Numbers: 2017-0870
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marielle PKJ Engelen, PhD, Texas A&M University:
Fish Oil supplement
HMB supplement

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases