CHF COPD Sip Feed Anabolic Response

NCT02770092 | Completed

• 1 other identifier: IRB2015-0676
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic obstructive pulmonary disorder (COPD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CHF and COPD patients, but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. The purpose of this study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CHF and COPD patients compared to matched healthy controls. This will provide required information that is necessary to implement new strategies to develop optimal nutritional regimen in CHF and COPD.

Conditions

Pulmonary Disease, Chronic Obstructive; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in net whole-body protein synthesis

  Change in whole-body protein synthesis rate after intake of meal

  0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 min

Secondary Outcomes (17)

• Body Composition

  15 minutes on screening or study day 1

• Skeletal muscle strength

  on study day 1

• Respiratory muscle strength

  on study day 1

• Gut function

  In postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on study day

• Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)

  Postabsorptive state during 3 hours and change after feeding on study day 1

Study Arms (3)

Healthy

EXPERIMENTAL

screening visit: body weight and composition by DXA, height, and vital signs will be assessed. study day(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing

Other: sip feeding with stable isotope infusion

Chronic Obstructive Pulmonary Disorder

EXPERIMENTAL

screening visit: body weight and composition by DXA, height, and vital signs will be assessed. study day(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing

Other: sip feeding with stable isotope infusion

Congestive Heart Failure

EXPERIMENTAL

screening visit: body weight and composition by DXA, height, and vital signs will be assessed. study day(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing

Other: sip feeding with stable isotope infusion

Interventions

sip feeding with stable isotope infusion OTHER

such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

Chronic Obstructive Pulmonary Disorder; Congestive Heart Failure; Healthy

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to walk, sit down and stand up independently
• Age 45 years or older
• Ability to lie in supine or elevated position for 8 hours
• Diagnosis of CHF; under regular care by cardiologist
• Reduced ejection fraction (\<45%) assessed in the past 2 years
• NYHA class II-IV
• Clinically stable condition; no hospitalization 4 weeks preceding first study day
• Willingness and ability to comply with the protocol
• Ability to walk, sit down and stand up independently
• Age 45 years or older
• Ability to lie in supine or elevated position for 8 hours
• Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 \< 70% of reference FEV1
• 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

You may not qualify if:

• Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
• Established diagnosis of malignancy
• History of untreated metabolic diseases including hepatic or renal disorder
• Presence of acute illness or metabolically unstable chronic illness
• Presence of fever within the last 3 days
• Body mass index \>40 kg/m2 (healthy subjects only)
• 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
• Use of protein or amino acid containing nutritional supplements within 5 days of first study day
• Current Use of long-term oral corticosteroids (CHF only)
• Use of short course of oral corticosteroids within 4 weeks preceding first study day
• Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
• (Possible) pregnancy
• Already enrolled in another clinical trial and that clinical trial interferes with participating in this study

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University-CTRAL

College Station, Texas, 77843, United States

Location

Related Publications (7)

• Berger MM, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Perez C, Thaden JJ, Engelen MPKJ, Deutz NEP. Cytokine response to critical illness and its relation to amino acid metabolism. Clin Nutr. 2025 Sep;52:195-202. doi: 10.1016/j.clnu.2025.07.018. Epub 2025 Jul 26.

  PMID: 40784156 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

• Deutz NEP, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Thaden JJ, Ten Have GAM, Engelen MPKJ, Berger MM. Females have a different metabolic response to critical illness, measured by comprehensive amino acid flux analysis. Metabolism. 2023 May;142:155400. doi: 10.1016/j.metabol.2023.155400. Epub 2023 Jan 27.

  PMID: 36717057 DERIVED

• Wierzchowska-McNew RA, Engelen MPKJ, Thaden JJ, Ten Have GAM, Deutz NEP. Obesity- and sex-related metabolism of arginine and nitric oxide in adults. Am J Clin Nutr. 2022 Dec 19;116(6):1610-1620. doi: 10.1093/ajcn/nqac277.

  PMID: 36166849 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

• Deutz NEP, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Thaden JJ, Ten Have GAM, Engelen MPKJ, Berger MM. Comprehensive metabolic amino acid flux analysis in critically ill patients. Clin Nutr. 2021 May;40(5):2876-2897. doi: 10.1016/j.clnu.2021.03.015. Epub 2021 Mar 18.

  PMID: 33946038 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

• Marielle Engelen

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 12, 2016
• Study Start: February 10, 2016
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)