Fish Oil and HMB Supplementation in COPD

NCT03796455 | Completed

• 1 other identifier: 2017-0870
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Fish Oil supplement; HMB supplement

Outcome Measures

Primary Outcomes (1)

• Changes to net whole body protein metabolism

  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

  baseline and after 10-week supplementation

Secondary Outcomes (6)

• muscle mass

  15 minutes on baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation

• limb muscle strength

  15 minutes on baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation

• respiratory muscle strength

  15 minutes on baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation

• functional performance via six minute walk test

  baseline visit, visit at week 5 of supplement intake, and after 10-week supplementation

• systemic inflammatory markers

  baseline visit and after 10-week supplementation

Study Arms (3)

Fish Oil

EXPERIMENTAL

2.0 g EPA + DHA / day + placebo powder

Dietary Supplement: Capsule + Powder supplementation; Other: stable tracer infusion

Fish Oil and HMB

EXPERIMENTAL

2.0 g EPA + DHA + 3.0 g HMB / day

Dietary Supplement: Capsule + Powder supplementation; Other: stable tracer infusion

Placebo

PLACEBO COMPARATOR

3 g/d soy oil: corn oil (50:50 ratio) + placebo powder

Dietary Supplement: Capsule + Powder supplementation; Other: stable tracer infusion

Interventions

Capsule + Powder supplementation DIETARY_SUPPLEMENT

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).

Fish Oil; Fish Oil and HMB; Placebo

stable tracer infusion OTHER

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

Fish Oil; Fish Oil and HMB; Placebo

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University-CTRAL

College Station, Texas, 77843, United States

Location

Related Publications (4)

• Engelen MPKJ, Simbo SY, Ruebush LE, Thaden JJ, Ten Have GAM, Harrykissoon RI, Zachria AJ, Calder PC, Pereira SL, Deutz NEP. Functional and metabolic effects of omega-3 polyunsaturated fatty acid supplementation and the role of beta-hydroxy-beta-methylbutyrate addition in chronic obstructive pulmonary disease: A randomized clinical trial. Clin Nutr. 2024 Sep;43(9):2263-2278. doi: 10.1016/j.clnu.2024.08.004. Epub 2024 Aug 10.

  PMID: 39181037 DERIVED

• Deutz LN, Wierzchowska-McNew RA, Deutz NE, Engelen MP. Reduced plasma glycine concentration in healthy and chronically diseased older adults: a marker of visceral adiposity? Am J Clin Nutr. 2024 Jun;119(6):1455-1464. doi: 10.1016/j.ajcnut.2024.04.008. Epub 2024 Apr 12.

  PMID: 38616018 DERIVED

• Engelen MPKJ, Kirschner SK, Coyle KS, Argyelan D, Neal G, Dasarathy S, Deutz NEP. Sex related differences in muscle health and metabolism in chronic obstructive pulmonary disease. Clin Nutr. 2023 Sep;42(9):1737-1746. doi: 10.1016/j.clnu.2023.06.031. Epub 2023 Jul 26.

  PMID: 37542951 DERIVED

• Pinson MR, Deutz NEP, Harrykissoon R, Zachria AJ, Engelen MPKJ. Disturbances in branched-chain amino acid profile and poor daily functioning in mildly depressed chronic obstructive pulmonary disease patients. BMC Pulm Med. 2021 Nov 7;21(1):351. doi: 10.1186/s12890-021-01719-9.

  PMID: 34743729 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: January 8, 2019
• Study Start: April 25, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)